Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, No. 46 “On the Rules for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices

Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016,
No. 46 “On the Rules for the Marketing Authorisation and Expert Assessment of the Safety,
Quality and Efficiency of Medical Devices

In accordance with para. 2 of Article 31 of the Eurasian Economic Union Treaty dated 29 May 2014, and paras. 2and 4 of Article 4 of the Agreement on Single Principles and Rules for the Circulation of Medical Devices (Articles of Medical Designation and Medical Equipment) within the Territory of the Eurasian Economic Union, dated 23 December 2014, and para. 92 of Addendum no. 1 to the Rules and Procedures of the Eurasian Economic Commission, as approved by a Decision of the Supreme Eurasian Economic Council dated 23 December 2014, no. 98, and in order to achieve implementation of the Decision of the Supreme Eurasian Economic Council dated 23 December 2014 no. 109 “On implementation of the Agreement for Single Principles and Rules for the Circulation of Medical Devices (Articles of Medical Designation and Medical Equipment) within the Territory of the Eurasian Economic Union”, the Council of the Eurasian Economic Commission has ruled as follows:

Approve the attached Rules for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices (hereinafter the Rules).
It shall be established that:
a) During the transitional period, i.e. until 31 December 2021,

marketing authorisation of the medical device may be performed, as chosen by the manufacturer of the medical device or its authorised representative, either in accordance with the Rules or in accordance with the legislation of the member state of the Eurasian Economic Union (hereinafter the Member States);

Medical devices registered in accordance with the Member State legislation shall circulate within the territory of the corresponding Member State;

b) all documents confirming the fact of the marketing authorisation of the medical devices issued by the authorised healthcare agency of the Member State in accordance with the relevant legislation of that member State, are valid until their relevant expiry dates, but no later than 31 December 2021.
All Member States shall, before 31 December 2016:
a) approve the amount of the fees, duties or any other mandatory payments, as provided by the Rules, in proper consideration of the overall complexity of the related procedures and number of tasks tobeperformed in each specific case in the reference Member State and in the recognizing states, including those applicable:

to the marketing authorisation of the medical device;

to the expert assessment of the safety, quality and efficiency of the medical device;

to any amendments to the marketing authorisation file of the medical device;

to issuing copies of the existing valid MAC;

b) identify bodies (authorities) responsible for marketing authorisation, amendments to the marketing authorisation file and any other marketing authorisation-related procedures, as per the Rules, and inform the Eurasian Economic Commission thereof.
This Decision comes into full force 10 calendar days after the entry into force of the protocol signed on 2 December 2015, regarding the accession of Armenia to the Agreement for Single Principles and Rules for the Circulation of Medical Devices (Articles of Medical Designation and Medical Equipment) within the Territory of the Eurasian Economic Union, dated 23 December 2014, but no later than 10 calendar days after the official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

On behalf of the Republic of Armenia
V. Gabrielyan

On behalf of the Republic of Belarus
V. Matiushevskij

On behalf of the Republic of Kazakhstan
B. Sagintaev

On behalf of the Republic of Kyrgyzstan
O. Pankratov

On behalf of the Russian Federation
I. Shuvalov

Rules
for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices(as approved by the Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, no. 46)

I. General Provisions

These Rules are developed in accordance with para. 2 of Article 31 of the Eurasian Economic Union Treaty dated 29 May 2014, and para.2 of Article 4 of the Agreement for Single Principles and Rules for the Circulation of Medical Devices (Articles of Medical Designation and Medical Equipment) within the Territory of the Eurasian Economic Union, dated 23 December of 2014, and set the procedure for the marketing authorisation and expert assessment of the safety, quality and efficiency of a medical device (hereinafter the marketing authorisation and expert assessment), amendment to the marketing authorisation file of a medical device, the issuing of copies of the existing valid MAC, as well as the procedure for the rejection of the marketing authorisation for the medical device, the suspension and/or withdrawal of the marketing authorisation certificate of the medical device within the territory of the Eurasian Economic Union (hereinafter the Union).

The requirements of these Rules are not applicable for medical devices to be used in the event of emergency, or those used for the diagnostics of emergent, endemic and/or highly dangerous infectious diseases, for which the circulation rules are governed by the related legislation of the Member States.

During the transitional period, the marketing authorisation of the medical device may be implemented as chosen by the manufacturer of the medical device or its authorised representative, either in accordance with the Rules or in accordance with the legislation of the Member State of the Union.
The concepts used in these Rules are described as follows:

“safety of medical devices” means the absence of an unacceptable risk associated with the harm caused to human life and health or damage to the environment;

“validation” means the confirmation via the provision of objective evidence of the fulfilment of requirements associated with any specific usage or application;

“software validation” is the process intended for the confirmation of the suitability of the software in terms of the performance of specific application tasks;

“verification” means confirmation based on the provision of objective evidence of the fulfilment of any specific requirements;

“software verification” is the process intended to confirm that the software is compliant with the specific requirements set for it (including those related to the terms of reference, specification, industry standards etc.);

“Recognizing State” means the Member State whose authorised body (expert authority) executes the procedure for the agreement of the expert conclusion made by the reference state;

“single register of medical devices registered within the Eurasian Economic Union” means the electronic database of all medical devices registered and authorised for medical use within the territory of the Union.

“Applicant” means the manufacturer who is a resident of the Member State, or its authorised representative;

“identification and labelling of the operation system” means analysis of the information related to the operational system used in the development of the software in order to evaluate the possibilities for protecting the software against unauthorised access;

“quality of the medical device” means the degree to which the combined properties and features of the medical devices are in correspondence with the goals assumed by its intended use;

“classification of medical device according to the potential risk of use” means the identification of the medical device as belonging to one of the classes of potential risk associated with the medical applications;

“component of the medical device” is a device which is not a medical device or its accessory, including but not limited to units, parts, elements of the device, materials, spare parts intended by the manufacturer for use as part of the medical device or in conjunction with the medical device;

“medical devices for in vitro diagnostics” -means any tools, apparatuses, devices, equipment, materials, reagents, calibrators, control materials and other devices for medical usage, used either individually or in conjunction/combination with each other, along with the accessories necessary for the intended usage of the aforementioned devices (including specific software), which are intended by the manufacturer specifically for in vitro testing and examination of human biological samples in order to obtain information regarding pathology or physiology of the human body, as well as for examination or determination of any inherent morbid conditions, pre-disposition for any known disease or clinical condition, for identification of tissue compatibility with the prospect recipient, forecasting of possible reaction for the therapy, as well as used for the selection of proper therapeutics and/or means of treatment control;

“modification of the medical device” means the version of the medical device which has common design features with the primary medical device; this variant is usually developed on the basis of the primary one in order to improve its functions, expand them or attain a more specific medical application for the device modified;

“multi-center study of the software” means simultaneous testing of the software under planned usage conditions at several external test sites outside the developing facility;

“medical device set (kit)” means a set or kit of medical devices which have a common single purpose and labelling; the set (kit) shall include also a list of individual components;

“accessory” is a non-medical device intended by the manufacture for usage in conjunction with one or more medical device assisting their intended use;

“manufacturer of the medical device” means the legal entity or person registered as the entrepreneur responsible for the development and manufacture of the medical device and/or making it available for usage regardless of whether it has been developed (manufactured) by this entity or person, or other persons (entities) producing this on their behalf; the aforementioned entities (persons) are ultimately responsible for the safety, quality and efficiency of the medical device;

“manufacturing site” means the industrial complex located on a specific confined territory and intended for the full cycle of the manufacturing of the medical device or certain stages of the process;

“consumables for medical devices” means other devices and/or materials which are spent during the routine usage of medical devices in order to ensure proper intervention in line with the intended use of the medical device;

“Marketing Authorisation File” is the set of documents and materials structured in a certain approved form which the applicant has to submit prior to the marketing authorisation of the medical device, in the event of the amendment of the issued marketing authorisation certificate; it also contains copies of decisions made by the authorised body (expert body) in relation to the medical device;

“registration number” means certain coded designations assigned to the medical devices upon marketing authorisation when they are included into the Single Register of Medical Devices Registered within the Union; this number is kept unchanged and must be referenced during the circulation of the medical device within the territory of the Union;

“Marketing Authorisation Certificate” is a document of a unified form confirming the fact of the medical device’s registration;

“marketing authorisation of a medical device” means the procedure for issuing permission for usage within the territory of the Union for a specific medical device provided by the authorised body of the Union;

“Reference State” -means the Member State selected by the applicant in which the authorised body implements the registration of the medical device;

“authorised representative of the manufacturer” means the legal entity or individual registered as entrepreneur, being a resident of the member State and authorised by the manufacturer of the medical device by Power of Attorney to act in the name of and on behalf of the manufacturer in terms of the circulation of the medical device within the territory of the Union, and in terms of fulfilment of all mandatory requirements set for medical devices;

Marketing authorisation and expert assessment of the medical device are mandatory conditions for its release into circulation within the territory of the Union, and this shall be done by the Authorised Body of the Reference State; Related requirements are the same for medical devices manufactured within the territory of the Union and for medical devices imported into the territory of the Union from any other third party states.
Prior to submission of the application for marketing authorisation to the Authorised Body of the reference state, the Applicant has to obtain evidence of the safety and efficiency of the medical device, and prepare the related marketing authorisation file.
In order to prepare the Marketing Authorisation File, the applicant has to do the following:
a) obtain preliminary conclusions from the expert authority dealing with the marketing authorisation and expert assessment of the medical device (if necessary);
b) perform technical tests and other necessary tests (studies) in order to evaluate the biological effect of the medical device, tests necessary to approve the measurement device type (this is relevant for the medical devices considered as measurement tools as per the List approved by the Commission), all this in order to confirm general requirements for the safety and efficiency of medical devices, as well as requirements for labelling and operational documentation, and has to be performed by the organisations and enterprises selected by the applicant, which are authorised for the performance of such tests/studies for the purpose of the marketing authorisation of medical devices, and are included in the Single Register of Authorised Organisations of the Union (hereinafter the Authorised Organisation).
c) perform clinical trials (studies) in accordance with the rules of implementation of clinical trials (studies) for medical devices in the Authorised Organisations selected by the applicant, or includes the data available in the marketing authorisation file.
In order to obtain the marketing authorisation of the medical device, an expert assessment shall be performed by the expert authority designated by the Authorised Body of the Member State (hereinafter the Expert Authority).
The manufacturer of the medical device shall ensure implementation and maintenance of the quality management system for the medical device, in accordance with the requirements for the implementation, maintenance and evaluation of the quality management system for medical devices based on the potential risk of usage, as approved by the Eurasian Economic Commission (hereinafter the Commission).
During the marketing authorisation and expert assessment of medical devices, the Authorised Bodies mutually recognise the results of technical tests and trials (studies) performed in order to evaluate the biological effect of the medical device, tests necessary to approve the measurement device type (this is relevant for the medical devices considered as measurement tools as per the List approved by the Commission), provided they are compliant with the rules and requirements set by the Commission.
The marketing authorisation of medical a device is performed by the Reference State on the basis of the outcome of an expert assessment, and on condition of approval of the expert conclusion by the Recognizing States.
The documentary evidence of the marketing authorisation of a medical device is the marketing authorisation certificate (MAC), drawn up as per the template provided in Appendix 1.

The MAC is issued for an unlimited period of time and is valid within the territory of the Union.

GARANT system:

See the Criteria for the delimitation of individual elements of the medical device regarded as components of the said device, as performed for the purpose of the marketing authorisation, approved by Decision of the Collegium of the Eurasian Economic Commission dated 24 July 2018, N 116

The registered medical device shall comply with the general requirements in terms of safety and efficiency, as well as with requirements concerning labelling and operational documentation, as approved by the Commission. The manufacturer or authorised representative of the manufacturer is ultimately responsible for the compliance of the medical device with the aforementioned general requirements.
All costs related to the marketing authorisation and expert assessment of the medical device are to be borne by the Applicant, in accordance with the related Member State’s legislation.
When several modifications of the medical device are simultaneously submitted to the marketing registration, and they belong to the same type of medical device as per the approved nomenclature of medical devices used in the Union, and when such modifications are made by the same manufacturer and differ in terms of the set contents and/or technical features which do not alter the main operational basis and functionality of the primary device, and belong to the same class of potential risk of usage, then the Applicant has to submit 1 application and 1 marketing authorisation file. When modifications are related to different variants or types of medical device (as per the aforementioned nomenclature), each modification needs an individual marketing authorisation procedure and requires an individual MAF submission.

GARANT system:

See the Criteria for several modifications of the medical device to be included in the same marketing authorisation certificate, provided they are related to the same type of medical devices as per the nomenclature of medical devices approved for the Eurasian Economic Union as per Decision of the Collegium of the Eurasian Economic Commission dated 24 July 2018, N 123

When the medical device registered as per the Rules is submitted for marketing authorisation in the Member States not stated previously by the Applicant as a Recognising State, as well as when an application is submitted for authorisation in the state which is a new Member State of the Union, the marketing authorisation has to be performed on the basis of the expert conclusion of the Authorised Body (Expert Authority) of the Reference State. In this case, the Authorised Body of the Reference State issues the marketing authorisation certificate stating all the Recognising States.

II. Procedures for the Marketing Authorisation and Expert Assessment of a Medical Device

In order to obtain the marketing authorisation of a medical device, the Applicant has to select theReference State and Recognising States.
The Applicant submits to the Authorised Body (Expert Authority) of the Reference State thefollowing documents:
a) an application for the expert assessment and marketing authorisation of a medical device (in paper and/or electronic form) as per the template provided in Appendix 2 and 3 (hereinafter in the Section the Application);

GARANT system:

See Requirements for the electronic forms of applications and documents constituting the marketing authorisation file to be submitted for the purpose of the marketing authorisation and expert assessment of the safety, quality and efficiency of the medical device, as approved by a decision of the Collegium of the Eurasian Economic Commission dated 30 June 2017, no. 78

b) the marketing authorisation file on electronic portable media, containing documents as per the list provided in Appendix 4. When the legislation of the Member State does not allow the aforementioned documents to be issued in e-form, the Authorised Body (Expert Authority) of the Reference State may have the right to request paper copies of such documents. The documents issued in foreign languages (not in Russian), shall be duly translated into Russian in accordance with the procedure provided by the applicable legislation of the relevant Member State;
c) documents confirming that any applicable fees have been duly paid for the expert assessment and marketing authorisation of the medical device in the Reference State.
The Authorised Body (Expert Authority) of the Reference State shall within 5 business days after receiving the Application and Marketing Authorisation File review this information for correctness and completeness and therefore decide on starting the marketing authorisation and expert assessment of the medical device and place the Application and the MAF in their information system. Information regarding medical devices subject to the marketing authorisation and expert assessment procedure, and documents constituting the Marketing Authorisation file, except the Instructions for Use and labelling of the medical device, are to be considered as confidential information and access to this information shall to be restricted and allowed only for the Authorised Bodies (Expert Authorities) of the Member States involved.

If the Application is submitted with a non-observance of the requirements set forth in those Rules, or contains inaccurate information, or if the MAF is not complete, then the Authorised Body (Expert Authority) of the Reference State shall, within 5 business days after receiving such Application and MAF, notify the Applicant about the need to rectify the related discrepancies and (or) about the need to provide the missing documents no later than 30 days after the notification was placed in the information system of the Authorised Body (Expert Authority) of the Reference State; the related notification has to be delivered to the Applicant personally against a signed acknowledgement, or it shall be delivered by registered mail with return receipt requested or transmitted via electronic means of communication or delivered in the form of an e-document bearing an e-signature.

Within the 3 days upon receiving the Application and MAF that are compliant with these Rules, the Authorised Body (Expert Authority) of the Reference State shall make its decision on the beginning of the procedure for the marketing authorisation and expert assessment of the medical device.

The Authorised Bodies (Expert Authorities) of the Recognising States have the right tofamiliarise themselves with the progress of the expert review conducted by the authorities of the Reference State, including the correspondence between the Applicant and the Authorised Body (Expert Authority) regarding the rectification of discrepancies, and with the documents submitted by the Applicant during the marketing authorisation and expert assessment of the medical device.
The Applicant is ultimately responsible for the accuracy of the MAF provided to the Authorised Body (Expert Authority).
If necessary, the Authorised Body (Expert Authority) may involve third party experts (not employed by the Authorised Body (Expert Authority)), provided their specific knowledge will be required todraw the expert conclusion.

Representative persons of Authorised Organisations conducting technical tests (trials) and studies in order to evaluate the biological effect, and those involved in clinical trials of the medical device submitted for expert evaluation, may not be involved in the expert assessment.

During the expert assessment, the expert shall not be related in any way to the body or person assigning such assessment, or manufacturer of the medical device, their authorised representative or any other persons interested in the results of the expert assessment.

When the expert knows there are certain circumstances which may prevent his/her involvement in the assessment, or such that prevent him/her from adhering to the principles of such an assessment procedure, they must report this to the head of the Authorised Body (Expert Authority) of the Reference State.

The Authorised Body (Expert Authority) of the Reference State performs an expert assessment of the medical device and issues an expert conclusion as per Appendix 5 within a maximum 60 business days after the date of a positive decision on the marketing authorisation and expert assessment procedure for the medical device.

Expert conclusions shall be unambiguous and clearly understandable.

In the event of a positive outcome of the expert assessment regarding the possibility of the marketing authorisation of the medical device in the Reference State, the Authorised Body of the Reference State shall within 5 business days after issuing the expert conclusion notify the Applicant about the need to submit copies of documents confirming the expert fee payment and registration fee payment in the Recognising States; this shall be done within 10 business days after the related notification is posted in the Reference State’s Authorised Body (Expert Authority) information system, or starting on the day when the Applicant received such notification personally with a signed acknowledgement, by registered mail with a return receipt requested, or in e-form via communication channels, or received the notification in the form of an e-document signed with an e-signature.

The Authorised Body (Expert Authority) of the Reference State, or their designated organisation in the Reference State shall inspect the manufacturing site of the medical device in question as per requirements set by the Commission. Such inspection shall be conducted prior the issuing of the expert conclusion. The time necessary to prepare and conduct such inspection is not counted towards the total time of the expert assessment procedure, and in total it shall be no longer than 90 business days.
The expert assessment of the medical device includes the following activities:
a) review of documents and materials which are critical for the safety, efficiency and quality of the medical device, including consumables and components of the medical device;
b) review of data related to the development and manufacturing of the medical device (process diagrams, description of the main process steps, packing, testing and release procedure for the end product);
c) review of standards applicable to the medical device;
d) review of technical test protocols (in terms of completeness of the test and competence of the test laboratory), and acceptance of test results as an outcome of this review;
e) review of inspection reports for the medical device;
f) review of reports on the biological effect of the medical device (in terms of completeness and quality of the tests and studies performed, and in terms of compliance with the rules applicable for tests, surveys or studies of the biological effect of the medical devices, as approved by the Commission), and therefore acceptance of the results of such tests, surveys or studies on the basis of the review;
g) analysis and evaluation of the clinical data contained in the Report on Clinical Proof of the Efficiency and Safety of the Medical Device, including compliance with the rules for clinical trials for medical devices as approved by the Commission, and review of the completeness of the trials conducted, as well as the accuracy of the results obtained, and comparison of the clinical data available with similar data from other sources, and therefore acceptance of the aforementioned results on the basis of the review;
h) evaluation of risks (stating the identified risks, generalised data for the validation and verification of trials and laboratory tests confirming feasibility of the implementation of scientific ideas in the end product, and including similar information found in literature);
i) evaluation of compliance with the claimed risk class (for the potential risk associated with the usage of the medical device), in accordance with the Rules for classification of a medical device with regard to the potential risk of usage, as approved by the Commission;
j) analysis of the correctness of the nomenclature classification of the medical device as per the related nomenclature used within the Union;
k) analysis of the safety and efficiency of the therapeutic drug used as part of the medical device, its effect on the functions of the medical device, compatibility of the therapeutic drug and the related medical device (except for medical devices for in vitro diagnostics) The therapeutic drug shall be registered and permitted for usage in the related manufacturing state.
l) review of the biological safety of the medical device based on the analysis of all materials of possible human or animal origin constituting this medical device, as well as information related to the selection of the sources (donors), material selection, material processing, storage, testing, validation of testing procedures, and handling of tissues, cells, and substances of human or animal origin, as well aswith viral and/or bacterial cultures;
m) review of the procedures and methods of sterilisation of the medical device, materials to justify the method of sterilisation, proposed QC methods and determination of the residual sterilising agent in the event of chemical sterilisation;
n) review of the validity of the software on the basis of review of the data available regarding its verification and validation, including information regarding its development and testing on the manufacturer site and in the multicenter trials, as well as data regarding identification and labelling of the operational system;
o) review of the Stability Report for the medical device, and justification of the storage term declared in the application;
p) review of the Plan for data gathering on the safety and efficiency of the medical device in the post-marketing period;
q) review of marketing information (when the medical device has been in circulation on the market for over 2 years) (if applicable);
r) review of information provided by the manufacturer concerning cases of emergency or recall related to the medical device (if any), and information about adverse events and (or) emergency cases related to the usage of the medical device, safety notifications related to the medical device (if any), as well as review of the approach used by the manufacturer in order to address the issues in each individual case, along with a description of corrective actions taken in response to the aforementioned cases; review of sales to emergency cases ratio and cases of recall of the medical device from the market on which it was previously approved;
s) review of the information provided by the manufacturer regarding compliance of the medical device with the general requirements for safety and efficiency of medical devices, as well as with requirements for labelling and operational documentation;
t) evaluation of the User Guide (Instructions for Medical Use) and operational documentation;
u) evaluation of the labelling of the medical device;
v) review of documents confirming results of tests of the medical devices in question performed in order to approve measurement tools type (for medical devices classified as measurement tools, as per the List approved by the Commission).
In the event that materials and data contained in the related application and in the documents constituting the Marketing Authorisation File are not sufficient for the Expert Authority to draw a definite conclusion, the Authorised Body (Expert Authority) sends the related request to the Applicant, stating the nature of the discrepancy and indicating possible corrective actions (hereinafter the Request). This Request shall be sent only once and can be transmitted to the Applicant personally against a signed acknowledgement, sent by registered mail with return receipt requested or transmitted in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature.

The Applicant must submit a response to the Request of the Expert Authority within a period not exceeding 60 business days from the date of receipt of the request. Should no answer to the Request be provided within the set period, the Authorised Body (Expert Authority) will take a decision on the basis of the documents available.

The time period from the date of the Request notification until the receipt of the response shall not be counted towards the total time of the expert assessment of the medical device.
The Authorised Body (Expert Authority) may refuse to grant the marketing authorisation to the medical device, under the following circumstances:
a) when materials and information contained in the Marketing Authorisation File do not confirm the safety, quality and/or efficiency of the medical device;
b) when the risk of damage to the health of patients and medical practitioners associated with the use of the medical device outweighs the related benefits;
c) when discrepancies found during the expert assessment will not be rectified in good time, and/or in the event of non-provision of missing documents in response to the Request duly made as per the Rules;
When necessary, the Authorised Bodies (Expert Authorities) of the Recognising States may use integrated systems of the Union in order to submit their notices and proposals to the Authorised Body (Expert Authority) of the Reference State prior to issuing the expert conclusion.

In the process of agreeing the said expert conclusion, the Authorised Bodies (Expert Authorities) of the Member States may communicate with each other in order to address any questions or issues that may arise during the process.

Upon issuing the expert conclusion, the Authorised Body (Expert Authority) of the Reference State shall post the text of this conclusion on the related information system. In turn, the Authorised Bodies (Expert Authorities) of the Recognising States shall within 30 calendar days after such publication of the expert conclusion made by the Authorised Body (Expert Authority) of the Reference State submit to the Authorised Body (Expert Authority) of the Reference State notification confirming approval or rejection of the expert conclusion (with justification) as per the form provided in Appendix 6, using the integrated information system of the Union, including such important items as the accuracy of the translation of the User Guide or Instructions for Medical Use and labelling of the medical device for the related languages of the Recognising States as per requirements provided in the legislation of the Member States.

If the Recognising States fail to provide confirmation of the approval or rejection of the expert conclusion within 30 calendar days after publication by the Authorised Body (Expert Authority) of the Reference State, the aforementioned expert conclusion shall be considered as approved.

Within 10 business days after approval of the aforementioned expert conclusion, the Authorised Body (Expert Authority) of the Reference State shall make a decision on the marketing authorisation of the medical device and post information regarding the medical device, its User Guide (Instructions for Medical Use) and copy of the approved label of the medical device in the Single Register of Medical Devices Registered within the Union.

The Authorised Body of the Reference State shall, within 10 business days after the decision on the marketing authorisation of the medical device, issue the Marketing Authorisation Certificate and related addendum, or inform the Applicant about the rejected application for marketing authorisation of the medical device in person against a signed acknowledgement, or deliver the notification via registered mail with notification of receipt, or shall transmit it by the e-communication channels or in the form of an e-document with an e-signature.

III. Procedure of agreement of the expert conclusion

During the agreement of the expert conclusion, the Recognising States shall evaluate the expert conclusion made by the Reference State in terms of its completeness and sufficiency of data confirming the safety, quality and efficiency of the related medical device.
Approval of the expert conclusion is the basis of a positive decision on the marketing authorisation of the medical device.
Agreement of the expert conclusion made by the Reference State may be refused if there is evidence that the efficiency and/or safety of medical device concerned are not confirmed by the facts provided in the Marketing Authorisation File, or when the risk of damage to the health of patients and medical practitioners associated with the use of the medical device outweighs related benefits.
If there is no consensus reached during the agreement of the expert conclusion, then discrepancies have to be solved by means of the Authorised Body of the Reference State addressing the Advisory Committee on Medical Devices in the Collegium of the Commission (hereinafter the Advisory Committee).

The Authorised Body (Expert Authority) of the Reference State shall use their official letter format to apply to the Advisory Committee about the need to review existing discrepancies and disagreement upon the subject matter and inform the Advisory Committee about the outcome of the previous negotiations and consultations. Any relevant material may be added to this application in order to justify the position of the Authorised Body (Expert Authority) of the Reference State with regard to the subject matter.

Upon receiving the application and attached materials thereto from the Authorised Body (Expert Authority) of the Reference State, the Advisory Committee shall request all other Authorised Bodies (Expert Authorities) of the Recognising States to submit materials justifying their related position with regard to the subject matter.

Upon receiving such materials from the Authorised Bodies (Expert Authorities) of the Recognising States, the Advisory Committee shall issue a notification about a meeting called in order to solve the disagreement issue to all the Authorised Bodies (Expert Authorities) involved.

The Advisory Committee shall ensure this meeting is called and shall host it in order to solve the issue. Representative persons from the Authorised Bodies (Expert Authorities) of the Reference State and Recognising States shall participate in this meeting.

The outcome of the meeting shall be a decision of recommendation.

This meeting shall be held within 30 business days after the application submitted by the Authorised Body (Expert Authority) of the Reference State to the Advisory Committee.

If one of the Recognizing States refuses to approve the expert conclusion made by the Reference State, this means that circulation of the medical device in this State will be prohibited.

IV. Expert review of amendments made to the Marketing Authorisation File

An expert review of amendments made to the Marketing Authorisation File has to be done by the Authorised Body (Expert Authority) of the Reference State, including evaluation of completeness and correctness of the documents, and considering the effect of the proposed amendments on the safety, quality and efficiency of the medical devices involved.
The manufacturer shall, within 2 months from the date of amendments of any of the documents constituting part of the Marketing Authorisation File, initiate management of the amendment procedure for the MAF involved by means of submitting the related application as per the form provided in Appendix 7 (hereinafter in this section the Application), to the Authorised Body (Expert Authority) of the Reference State, and attach documents confirming such amendments, as per the list provided in Appendix 8.
The Application and the substantiating documents must be posted by the Authorised Body (Expert Authority) of the Reference State in the related information system under restricted access mode (access available only to the concerned Authorised Bodies (Expert Authorities) of the Member States).
The Authorised Bodies (Expert Authorities) of the Recognising States may, within 30 business days after posting the Application and the substantiating documents by the Authorised Body (Expert Authority) of the Reference State in the related information system, use the Integrated system of the Union in order to submit their own proposals or notices to the Authorised Body (Expert Authority) of the Reference State prior to the expert conclusion being made as per Appendix 9.

Within 5 business day after receipt of the Application and the substantiating documents, the Authorised Body (Expert Authority) of the Reference State shall verify them for correctness and completeness of the information provided.

If the Application has not met the requirements set forth in those Rules, or contains inaccurate information, or if the substantiating documents are not provided in full, then the Authorised Body (Expert Authority) of the Reference State shall, within 30 business days after receiving this Application and MAF notify the Applicant about the need to rectify the related discrepancies and (or) about the need to provide the missing documents, the related notification has to be delivered to the Applicant personally against a signed acknowledgement, or it shall be delivered by registered mail with return receipt requested or transmitted via electronic means of communication or delivered in the form of an e-document bearing an e-signature.

Within 3 business days upon receipt of the duly drawn up Application and the substantiating documents, the Authorised Body (Expert Authority) of the Reference State shall make its decision on the beginning of the procedure for commencing amendments to the Marketing Authorisation File.

The applicant must submit a response to the request of the Authorised Body (Expert Authority) within a period not exceeding 60 business days from the date of receipt of the request. Should no answer to the request be provided within the set period, the Authorised Body (Expert Authority) will make a decision on the basis of the documents available.
The time period from the date of the request notification send by the Authorised Body (Expert Authority) until receipt of the response shall not be counted towards the total time of the expert assessment of the medical device.
Amendments to the MAF shall be made on the basis of the expert conclusion on the proposed amendments no later than within 30 business days after submission of the duly drawn up Application and the substantiating documents.
The Authorised Body (Expert Authority) of the Reference State may decide to refuse to make amendments to the Marketing Authorisation File, on the following conditions^
a) inaccuracy of any information justifying the introduction of changes;
b) lack of evidence to support the consistent functionality and/or the principle of operation of the medical device in connection with the proposed amendments;
c) when discrepancies found during the expert assessment were not rectified in good time, and/or in the event of the non-provision of missing documents;
The expert conclusion and User Guide (Instructions for Medical Use), the image of the registered labelling of the medical device (in Russian) shall be posted by the Authorised Body (Expert Authority) of the Reference State in its related information system under restricted access available only to the Authorised Bodies (Expert Authorities) concerned.
The Recognising States shall, within 10 business days after posting the expert conclusion by the Authorised Body (Expert Authority) of the Reference State in its related information system, submit to the Authorised Body (Expert Authority) of the Reference State their notices and proposals on the subject matter (with justification).
If the amendments involve the Marketing Authorisation Certificate, the Authorised Body (Expert Authority) of the Reference State shall issue a new certificate keeping its previous number and stating the date of the related amendments.
The Authorised Body of the Reference State shall, within 10 business days after making the related decision
a) issue the MAC;
b) amend the Single Register of the Medical Devices Registered within the Union with the information about amendment of the MAF, as per the procedure approved by the Commission, and attach scanned copies of the amended documents;
c) inform the Applicant about the refusal to make amendments to the Marketing Authorisation File; the related notification has to be delivered to the Applicant personally against signed acknowledgement, or it shall be delivered by registered mail with a return receipt requested or transmitted via electronic means of communication or delivered in the form of an e-document bearing an e-signature.

V. Procedure for the suspension or cancellation of a Marketing Authorisation Certificate

Suspension of an existing and valid Marketing Authorisation Certificate may be applied by the Authorised Body of the Reference State under the following conditions:
a) upon receiving information about the potential serious risk to public health as a result of post-marketing monitoring of the safety, quality and efficiency of the medical device;
b) when there are findings concerning the facts and circumstances which potentially constitute a threat to human health and well-being (both to the general public and medical professionals) associated with the use and/or operation of the medical devices, as a result of the state monitoring of the circulation of medical devices.
The decision to suspend the validity of the MAC (stating the reasons, date of implementation and duration of the suspension period) has to be taken by the Authorised Body of the Reference State in accordance with the legislation of that Reference State.
The suspension period for any MAC shall not be longer than 6 months, during which the distribution and application of the affected medical devices within the Union are prohibited.

The Authorised Body of the Reference State shall immediately inform the Authorised Bodies of the Recognising States, the manufacturer or its authorised representative, and the Commission, about the suspension of the Marketing Authorisation Certificate involved, and makes the related amendments to the information in the Single Register of Medical Devices Registered within the Union.

The Applicant shall, within the period determined by the Authorised Body of the Reference State, rectify the circumstances resulting in the suspension of the MAC, and notify the Authorised Body, attaching substantiating documents. Upon review of the submitted documents, the Authorised Body of the Reference State decides either to restore the validity of the related Marketing Authorisation Certificate, or to cancel the aforementioned MAC, stating the date of such restoration or cancellation.
The Authorised Body of the Reference State informs the Applicant about the restoration of the validity of the related Marketing Authorisation Certificate within 5 business days; the related notification has to be delivered to the Applicant personally against signed acknowledgement, or it shall be delivered by registered mail with a return receipt requested or transmitted via electronic means of communication or delivered in the form of an e-document bearing an e-signature.

A decision to restore the validity of the Marketing Authorisation Certificate shall be made in accordance with the related legislation of the Reference State, and enters into force on the day of issue.

If the Applicant fails to rectify the circumstances resulting in the suspension of the validity of the MAC, the Authorised Body of the Reference State decides on the cancellation of the related Marketing Authorisation Certificate with due substantiation of this decision.

The Authorised Body of the Reference State shall immediately notify the Applicant about this cancellation of the Marketing Authorisation Certificate; a related notification has to be delivered to the Applicant personally against signed acknowledgement, or it shall be delivered by registered mail with a return receipt requested or transmitted via electronic means of communication or delivered in the form of an e-document bearing an e-signature, and related amendments shall be made to the information in the Single Register of Medical Devices Registered within the Union.

The Authorised Body of the Reference State may also decide on the cancellation of the Marketing Authorisation Certificate on the basis of a related application submitted by the manufacturer of the medical device or its authorised representative, whose application shall be as per the template provided in Appendix 10.

The following conditions or circumstances may be considered as a basis for the decision of the Authorised Body of the Reference State to cancel a valid Marketing Authorisation Certificate:
a) an application submitted by the manufacturer of the medical device or its authorised representative, asking for such cancellation;
b) when certain findings become obvious suggesting that the Applicant submitted inaccurate information which was not discovered during the initial marketing authorisation;
c) a related court decision made and enforced in any of the Member States;
d) provision of information by the Authorised Body of the Member State (as the result of governmental monitoring of the circulation of medical devices) confirming that there are facts and circumstances threatening the life and health of citizens and medical professionals when operating and using the medical device;

e) loss of medical status by the related medical device due to changes made in the legal acts of the Union.

VI. Procedure for Issuing a Duplicate of an existing Marketing Authorisation Certificate

In the event of a lost or damaged Marketing Authorisation Certificate, the Applicant has the right to request the Authorised Body of the Reference State about issuing a duplicate of the existing MAC as per the template provided in Appendix 11.
When the original Marketing Authorisation Certificate is damaged, and the damaged certificate shall be attached to the application for a duplicate.
Within 7 business days from the receipt of such application, the Authorised Body of the Reference State shall issue a duplicate of the existing MAC using the actual version of the MAC template and issue it to the applicant or deliver it by registered mail with a return request receipt.

Appendix no. 1
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of a Marketing Authorisation Certificate and rules for its issue

Template of a Marketing Authorisation Certificate

Emblem of the Eurasian Economic Union (1)

EURASIAN ECONOMIC UNION (2)

____________________________________________________________________________________________________

(Full name of the Authorised Body of the Reference State) (3)

MARKETING AUTHORISATION CERTIFICATE (4)

МИ-ХХ-N ______ (5)

In accordance with the _______________________________________________________________________________ (6)

(Number and date of the Order of the Authorised Body of the Reference State)

this Marketing Authorisation Certificate is issued to: __________________________________________________

_____________________________________________________________________________________________________ (7)

(Full name of manufacturer and its location, including country and registered address)

_____________________________________________________________________________________________________ (8)

(Full name of manufacturing sites, including location (registered address))

_____________________________________________________________________________________________________ (9)

(Name of the authorised representative on the territories of the Member States

of the Eurasian Economic Union, including location (registered address))

In order to certify that _____________________________________________________________________________ (10)

(Full name of the medical device)

Class of potential risk of the use of medical device: ________________________________________________ (11)

Type of the medical device as per the nomenclature used within the

Eurasian Economic Union _______________________________________________________________________________(12)

Is authorised and released for marketing and circulation within the Eurasian Economic Union

_______________________________________________________________________________________________________(13)

(Full name of the Member State of the Eurasian Economic Union)

The list of components, accessories and consumables applicable to the modification of the medical device

is provided in the Appendix to this Marketing Authorisation Certificate on ____ pages. (14)

This Appendix is an integral part of this Marketing Authorisation Certificate (15)

Term of validity of this certificate: unlimited (16)

Date of registration “__” of ________, 20__ (17)

Date of amendment “__” of ________, 20__ (18)

________________________________________________________________________________________

(Full name of the head person (authorised person) of the Authorised Body of the Reference State)

_______________________ place for stamp (19)

(signature)

N _________ (20)

Appendix to the Marketing Authorisation Certificate

МИ-ХХ-N ______ (1)

┌─────┬──────────────────────────────────────────────────────┐

│ N │ Name of the components of the medical device │

│ │ │

├─────┼──────────────────────────────────────────────────────┤

│ 1. │ Main units (parts) of the medical device │

├─────┼──────────────────────────────────────────────────────┤

│ 2. │ Accessories (if applicable) │

├─────┼──────────────────────────────────────────────────────┤

│ 3. │ Consumables (if applicable) │

├─────┼──────────────────────────────────────────────────────┤

│ 4. │ Components (if applicable) │

└─────┴──────────────────────────────────────────────────────┘

(2)

___________________________________________________________________________

(Full name of the head person (authorised person) of the Authorised Body
of the Reference State)

_______________________ place for stamp (3)

(signature)

“__” of ________, 20__

II. I. Rules for issuing the Marketing Authorisation Certificate

The Marketing Authorisation Certificate has to be completed by the Authorised Body of the Member State of the Eurasian Economic Union which is responsible for the marketing authorisation of the aforementioned medical device, in Russian, using electronic printing devices and, if applicable as per the related requirements of the legislation of the Reference State, in the official language of that state.
In the Marketing Authorisation Certificate, the text in Russian and in the official language of the Recognising State shall be placed on different sides of the Marketing Authorisation Certificate’s main page.
A Marketing Authorisation Certificate is a strict accounting document, so related document sheets shall be printed by typography.

If necessary, the use of Latin letters is permitted for the designation of the name of the manufacturer, its location (registered address), physical address (except the name of the state) and certain product-related information (such as type, make, model, article code etc.).

All fields of the Marketing Authorisation Certificate shall be filled in (please consider that in the original Marketing Authorisation Certificate sheet there is no numbering of the fields).
The Marketing Authorisation Certificate shall contain the following mandatory information:
a) in field 1 — emblem of the Eurasian Economic Union;
b) in field 2 — 1 line of the following text:

“EURASIAN ECONOMIC UNION”;

c) in field 3 — Full name of the Authorised Body of the Reference State;
d) in field 4 — one line of the following text: “Marketing Authorisation Certificate”;
e) in field 5 — registration number of the Marketing Authorisation Certificate and date of issue.

The registration number of the Marketing Authorisation Certificate is composed as follows:

МИ – Х Х – ХХХХХХ,

── ─ ─ ──────

1 2 3 4

where

Element 1 is the abbreviation for the Medical Device (in Russian);

Element 2 is a 2-letter code indicating the Reference State as per the Countries of the World Classification Table;

Element 3 is a 2-letter code indicating the Recognising State as per the Countries of the World Classification Table (codes shall be provided for all Recognising States which have confirmed acceptance of the expert conclusion made by the Reference State).

Element 4 is the 6-digit serial number of the Marketing Authorisation Certificate assigned by the Authorised Body of the Reference State (this is assigned automatically on the basis of the Single Register of Medical Devices Registered within the Eurasian Economic Union):

f) in field 6 the number and date of the Order of the Authorised Body of the Reference State;
g) in field 7 the full name of the manufacturer, manufacturing country, manufacturer’s location (registered address) and physical address — for the legal entity and/or its subsidiaries which are involved in the manufacturing process, or residential address for an individual entrepreneur (person);
h) in field 8 the full name of the manufacturing sites and their location (registered address) and physical address — for the legal entity and/or its subsidiaries which are involved in the manufacturing process, or residential address for an individual entrepreneur (person);
i) in field 9 the full name of the authorised representative of the manufacturer on the territory of the Member State, manufacturer’s location (registered address) and physical address — for the legal entity and/or its subsidiaries which are involved in the manufacturing process, or residential address for an individual entrepreneur (person);
j) in field 10 the full name of the medical device as stated in the expert conclusion made by the Authorised Body of the Reference State, trade name of the medical device (if applicable), information regarding the medical device necessary for its identification (type, make, model, article code etc.);
k) in field 11 the class of risk associated with potential usage of the medical device, as confirmed by the expert assessment made by the Reference State;
l) in field 12 the type of medical device as per the nomenclature used within the Eurasian Economic Union;
m) in field 13 the names of the Reference and Recognising States;
n) in field 14 the number of pages (sheets) in the appendix to the Marketing Authorisation Certificate (to be filled in if an appendix is issued);
o) in field 17 the date of the registration of the medical device, which has to be designated in a combined way: the numeral (day of the month) by two Arabic digits (in parentheses), month as written, and the year by four Arabic digits (adding abbreviated “г.” for “year”).
p) in field 18 the date of amendments (if any) made to the Marketing Authorisation Certificate, which has to be designated in a combined way: the numeral (day of the month) by two Arabic digits (in parentheses), month as written, and the year by four Arabic digits (adding abbreviated “г.” for “year”). This field has to be completed in the event of amendments made to the Marketing Authorisation File which resulted in the issue of a new Marketing Authorisation Certificate, albeit with the same number;
q) in field 19 the title, first name, patronymic (if applicable) and surname of the head (or his/her authorised designate) of the Authorised Body issuing the Certificate, along with the signature of the person and stamp of the Authorised Body. The signature shall be made by the person himself/herself, no use of a facsimile is allowed.
r) in field 20 the typographic number, serial number and serial code of the registration sheet indicated during its printing.
If the medical device contains main parts (units), along with other components, accessories or consumables, the Appendix to the Marketing Authorisation Certificate shall also be completed, being an integral part of the Marketing Authorisation Certificate. Each sheet of the Appendix shall be numbered. The Appendix to the Marketing Authorisation Certificate shall contain the following information:
a) in field 1 the registration number of the Marketing Authorisation Certificate and date of issue;
b) in field 2 the list of components of the medical device, including the main units (parts), components, accessories and consumables, indicating the model (if applicable);
c) in field 3 the title, first name, patronymic (if applicable) and surname of the head (or his/her authorised designate) of the Authorised Body issuing the Certificate, along with the signature of the person and stamp of the Authorised Body. The signature shall be made by the person himself/herself, no use of a facsimile is allowed.
When completing the Marketing Authorisation Certificate and/or related Appendix, it is not allowed to state any information other than that stipulated in this Rules; the use of abbreviated forms of words (except common ones) and correctives is not allowed.
If the original Marketing Authorisation Certificate is damaged or lost, the Authorised Body of the Reference State issues a duplicate of the original existing certificate. In this case, the following shall be stated in writing in the top right corner of the certificate sheet: “The duplicate is issued on “__” _______ 20___ and “the original copy of this certificate shall be considered as null and void”.

Appendix no. 2
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of an Application for Expert Assessment of a Medical Device

To the Authorised Body (Expert Authority)

Of the Member State

Of the Eurasian Economic Union

_______________________________________

(Name of the Reference State)

_______________________________________

(Name of the Recognising State)

APPLICATION

for Expert Assessment of the Medical Device

______________________________________________________________________________

(Full and abbreviated name (if applicable), including brand name,

of the organisation on behalf of which the marketing authorisation is done

(The manufacturer (authorised representative of the manufacturer),

legal form of the entity)

Hereby we ask you to perform an expert assessment of the medical device, acting as____________________________________________________________________________

(Reference State/Recognising State, specify as applicable)

Name of the medical device

Intended use of the medical device

Scope of use of the medical device

Class of potential risk of use of the medical device

Type code of the medical device (as per the Nomenclature of Medical Devices used within the Union)

The medical device contains a therapeutic drug for release (highlight the necessary item)

Yes

Composition of the medical device

Name of device

Model

Manufacturer

Country

1) Main unit

(if applicable)

2) Components

(if applicable)

3) Consumables

(if applicable)

4) Accessories

(if applicable)

Shelf life/warranty service life

Storage conditions

10.

Marketing Authorisation in the country of origin and in other countries

Name of the country

No. of the Marketing Authorisation Certificate

(if applicable)

Date of issue

Validity term

…

11.

Manufacture

Completely on the stated manufacturing site

Partly on the stated manufacturing site

Completely on another manufacturing site

12.

Information about the manufacturer

name of the manufacturer, country

number, date of issue and validity term of the related permit

registered address

physical address

phone and fax numbers, email address (if applicable)

full name and title of head person

full name and title of contact person

13.

Information regarding manufacturing site(s)

name of the manufacturer, country

number, date of issue and validity term of the related permit (if applicable)

physical address

phone and fax numbers, email address (if applicable)

full name and title of head person

full name and title of contact person

14.

Information about the authorised representative (if applicable)

name of the manufacturer, country

number, date of issue and validity term of the related permit (if applicable)

registered address

physical address

phone and fax numbers, email address (if applicable)

full name and title of head person

full name and title of contact person

15.

Information about the document confirming the duly paid fee for the expert assessment of the medical device

I hereby guarantee the accuracy and identity of the information contained in the Marketing Authorisation File and in the Application.

Date of application

Full name and title of the head person of the manufacturer (authorised representative)

Signature, stamp of the manufacturer (authorised representative)

Appendix no. 3
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of a Medical Device

TEMPLATE
of an Application for the Marketing Authorisation of a Medical Device

To the Authorised Body of the Member State

of the Eurasian Economic Union

_______________________________________

(Name of the Reference State)

_______________________________________

(Name of the Recognising State)

APPLICATION

for the Marketing Authorisation of a Medical Device

(Full and abbreviated name (if applicable), including brand name,

of the organisation on behalf of which the marketing authorisation is done

(The manufacturer (authorised representative of the manufacturer),

legal form of the entity)

Hereby we ask you to perform the marketing authorisation of the medical device, acting as _______________________________________________________________

(Reference State/Recognising State, specify as applicable)

1.	Name of the medical device
2.	Intended use of the medical device
3.	Scope of use of the medical device
4.	Class of potential risk of use of the medical device
5.	Type code of the medical device (as per the Nomenclature of Medical Devices used within the Union)
6.	The medical device contains a therapeutic drug for release (highlight the necessary item)						о		Yes
							о		No
7.	List of components
8.	Information about the manufacturer
N	name of the manufacturer, country	number, date of issue and validity term of the related permit	registered address		physical address	phone and fax numbers, email address (if applicable)		full name and title of head person		full name and title of contact person
9.	Information regarding manufacturing site(s)
N	name of the manufacturer, country	number, date of issue and validity term of the related permit (if applicable)		physical address		phone and fax numbers, email address (if applicable)		full name and title of head person		full name and title of contact person
10.	Information about the authorised representative (if applicable)
N	name of the manufacturer, country	number, date of issue and validity term of the related permit (if applicable)	registered address		physical address	phone and fax numbers, email address (if applicable)		full name and title of head person		full name and title of contact person
11.	Information about the document confirming the duly paid official fee for the marketing authorisation of the medical device
I hereby guarantee the accuracy and identity of the information contained in the Marketing Authorisation File and in the Application.
Date of application
Full name and title of the head person of the manufacturer (authorised representative)
Signature, stamp of the manufacturer (authorised representative)

Appendix no. 4
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

THE LIST
of documents necessary for the marketing authorisation of a medical device, and template of the reference statement for the medical device

Item No.	Document name	Class of the medical device				Medical device for in vitro diagnostics (Regardless of the class of potential risk of use)	Note.
Item No.	Document name	1	2a	2b	3		Note.
1.	Application	+	+	+	+	+	As per templates provided in Appendix 2and 3 to the Rules
2.	Power of Attorney issued by the manufacturer in order to act on its behalf during the marketing authorisation (If necessary)	+	+	+	+	+	As per international rules for witnessing, or as per norms for witnessing established by the respective legislation of the Member State of the Eurasian Economic Union (hereinafter the Member State)
3.	Copy of the permit for manufacturing issued in the manufacturing state, along with the appendix (if applicable)	+	+	+	+	+	As per international rules for witnessing, or as per norms for witnessing established by the respective legislation of the Member State
4.	Copies of the certificates of Quality Management Systems used by the manufacturer of the medical devices (ISO 13485 or related regional or national standard of the member State (if applicable))	+	+	+	+	+	As per international rules for witnessing, or as per norms for witnessing established by the respective legislation of the Member State
5.	Declaration of conformity with the requirements for safety and efficiency of medical devices, or equivalent document (if applicable)	+	+	+	+	+
6.	Copy of the Marketing Authorisation Certificate (Free Sales certificate, export certificate (except for medical devices newly produced on the territory of the Member State)) issued in the country of manufacture (if applicable), translated into Russian	+	+	+	+	+	As per international rules for witnessing, or as per norms for witnessing established by the respective legislation of the Member State
7.	Copy of the document confirming marketing authorisation in other countries (if applicable)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
8.	Reference statement for the medical device, containing a description of the scope of use, a short general description of the medical device, variants of implementation and components (as per the template)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
9.	Information regarding labelling and packing (full colour layouts of the packing and labelling, with the text provided in Russian and in the official languages of the Member States)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
10.	Information related to the development and manufacture of the medical device (process diagrams, description of main process stages, packing, testing and release procedure for the end product)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
11.	Information regarding the manufacturer: name, type of activity, registered address, type of ownership, list of senior management, list of divisions and subsidiaries, stating their status and terms of reference	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
12.	Marketing information (when the device has been circulating on the market for more than two years, if applicable)	–	–	+	+	+ (Except for classes 1 and 2a)	Certified by the manufacturer (or its authorised representative)
13.	Information about any health related emergencies and recalls (not to be provided for newly developed and designed medical devices): List of adverse events and/or emergencies related to the use of the medical device, stating the reporting period; If there an excessive number of AEs, provide short summaries for each type of such event and state the total amount of related AE reported for each category; List of recall issues and/or notifications, along with a description of the approach used to address the issues, and list the individual solutions used by the manufacturer in each specific case; description of the related analysis and/or corrective actions taken in response to each issue;	+	+	+	+	+ (Except for class 1)	Certified by the manufacturer (or its authorised representative)
14.	List of standards to be complied with (with related information)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
15.	Information regarding compliance of the medical device with the general requirements for safety and efficiency of medical devices, as well as with the requirements for labelling and operational documentation (hereinafter the general requirements)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
16.	Document setting out the requirements for the specifications (performance characteristics) of the medical device	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
17.	Technical test records, for the tests performed in order to prove compliance with the general requirements	+	+	+	+	+ (Except for reagents/reagent kits)
18.	Test records for the studies (tests) performed in order to assess the biological effect of the medical device and in order to prove compliance with the general requirements	+	+	+	+	–
19.	Report on clinical proof of the efficiency and safety of the medical device	+	+	+	+	+ (Except for class 1)	Certified by the manufacturer (or its authorised representative)
20.	Risk analysis report	–	+	+	+	+ (Except for class 1)	Certified by the manufacturer (or its authorised representative)
21.	Information regarding treatment drugs used as a component of the medical device (composition of the said drug, amount, information regarding compatibility with the medical device, information about the marketing authorisation of the therapeutic drug involved in the country of manufacture)	+	+	+	+	–	Certified by the manufacturer (or its authorised representative)
22.	Data concerning biological safety (if applicable)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
23.	Data regarding the sterilisation procedure, including information regarding process validation, test results for bioburden testing, pyrogenicity, sterility test (if necessary), along with a description of the test methods used, and information regarding packing validation (for sterile items)	+	+	+	+	+ (Except for class 1)	Certified by the manufacturer (or its authorised representative)
24.	Information regarding specific software (if applicable): manufacturer’s information regarding software validation	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
25.	Stability test report, with the authentic translation of all test results and conclusion into Russian, for all medical devices which have a specified shelf life	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
26.	Operational document or instruction for use of the medical device, written in the official language of the Recognition State (if necessary) and in Russian	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
27.	Service manual (for components of the medical device), when relevant data are not provided in the operational documentation (if applicable)	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
28.	Manufacturing site inspection report	+	+	+	+	+
29.	Plan for data gathering on the safety and efficiency of the medical device in the post-marketing period	+	+	+	+	+	Certified by the manufacturer (or its authorised representative)
30.	Documents confirming the results of tests of the medical devices in question performed in order to approve the measurement tools type (for medical devices classified as measurement tools, as per the List approved by the Commission) (If necessary)	+	+	+	+	+

(template)

Reference statement for the medical device

Name of device	Manufacturer (Country)	Contents (list of components)				Scope of application, intended use	Short description of the medical device
		Name of component	model	manufacturer	country
		1. Main units (parts) of the medical device
		2. Accessories (if applicable)
		3. Supplies (if applicable)
		4. Components (if applicable)

Appendix no. 5
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

EXPERT CONCLUSION
on the assessment of the safety, efficiency and quality of medical devices
as part of marketing authorisation

Specification of the medical device:
a) name;
b) manufacturer, country;
c) manufacturing site, country;
d) scope of application, intended use;
e) type of the medical device as per the Nomenclature used within the Eurasian Economic Union;
f) class of potential risk of use of the medical device;
g) description of components and consumables;
h) description or list of the modifications of the medical device
i) composition of the medical device;
h) materials used for manufacturing of the medical device;
j) main technical features (performance characteristics).
Information on the certification of the quality management system (if applicable):

The quality management system is certified for compliance with the requirements of:

_________________________________________________________________________

(List of certificates, including identification items such as registration number, date of issue, validity term, name of the issuing body)

Development and manufacture:
a) evaluation of the data provided by the manufacturer related to development and manufacturing, including review of the manufacturing inspection (if applicable);
b) conclusion regarding compliance of the development, production process and quality control with the principles of a safe and quality production process.
Standards used by the manufacturers of medical devices, including those applicable to the production materials, components, consumables and test methods which were used during the technical tests, trials (studies) of the biological effect, and during clinical trials involving the medical device;
Justified conclusion on the compliance with the general requirements in terms of safety and efficiency, as well as with the requirements concerning labelling and operational documentation, (hereinafter the general requirements).
Document setting out requirements for the specifications (performance characteristics) of the medical device:
a) analysis of the document’s compliance with the general requirements;
b) conclusion regarding compliance of the medical device’s specifications (performance characteristics) with the general requirements.
Evaluation of technical tests and studies (trials) with the purpose of evaluating the biological effect:
a) evaluation of technical test records for testing the biological effect in terms of completeness and accuracy of those tests as compared with the manufacturer’s specifications and/or other specifications as applicable (if any);
b) conclusion on completeness and accuracy of technical tests and studies (trials) performed with the purpose of evaluating the biological effect.
Review of clinical trial results or clinical data available:
a) review of compliance of the clinical trials (study) data with the rules for the implementation of clinical trials for medical devices, as approved by the Commission, as well as evaluation of the completeness and accuracy of the results of such studies (trials);
b) conclusion on compliance of the clinical trials (study) data with the rules for the implementation of clinical trials for medical devices, as approved by the Commission, as well as evaluation of the completeness and accuracy of the results of such studies (trials), and on justification of the conclusions made on the basis of the trial data;
c) evaluation of the report on the clinical proof of the efficiency and safety of the medical device
Risk analysis: conclusion on the completeness and accuracy of the risk analysis.
Medical devices containing therapeutic drugs: conclusion on the safety and efficiency of the medical device containing a therapeutic drug, on its effect on the functions of the medical device, and on compatibility of this therapeutic drug with the medical device.
a) Biological safety of the medical device: conclusion on the biological safety of the medical device based on an analysis of all the materials of possible human or animal origin constituting this medical device, as well as nano-particles, gene-engineered organisms and other newly developed materials, as well as on information related to the selection of the sources (donors), material selection, material processing, storage, testing, validation of testing procedures, and handling of tissues, cells, and substances of human or animal origin, as well as with viral and/or bacterial cultures.
Sterilisation: a review of procedures and methods of sterilisation of the medical device based on information on the development of sterilisation methods used for the medical device and related materials, materials to justify the method of sterilisation, proposed QC methods and determination of the residual sterilising agent in the event of chemical sterilisation.
Medical devices containing specific software: conclusion on the validity of the software on the basis of a review of the data available regarding its verification and validation, including information regarding its development and testing on the manufacturer’s site and in the multicenter clinical trials, as well as data regarding identification and labellingof the operational system.
Review and conclusion on stability data for the medical device.
Review of the plan for data gathering on the safety and efficiency of the medical device in the post-marketing period.
Review and conclusion of marketing information (when the device has been circulating on the market for more than two years, if applicable).
Analysis of information about emergency and adverse event feedback related to the use of the medical device in question; review of recall cases and/or notifications related to the medical device, written reports on the response in the event of recall of the medical device and rectification of the related circumstances, description of corrective actions taken by the manufacturer in response of these recall issues, as well as a review of the sales to emergency/recall issues ratio (this is not applicable to newly developed and designed medical devices).
Review of information provided by the manufacturer considering compliance of the medical device with the general requirements.
a) conclusion on the correctness of the determination of the requirements related to the medical device, and to the completeness and accuracy of evidence of its compliance with the general requirements.
Review of the manufacturing site inspection report (if applicable).
Review of documents confirming results of the tests of the medical devices in question performed in order to approve measurement tools type (for medical devices classified as measurement tools, as per the List approved by the Commission) (If necessary).
General conclusion on the confirmation (or inability to confirm) of the safety, quality and efficiency of the medical device, and subsequent recommendation (refusal to recommend) for the possibility to provide marketing authorisation for this medical device.
Full name, academic credentials (title) (if applicable), signature of the expert involved in this conclusion.
Date of the report’s completion.
Signature of the Head of the Expert Authority.
Stamp of the expert authority.

Appendix no. 6
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of conclusion on approval (refusal to approve) of the expert conclusion made on the basis of the expert assessment of safety, quality and efficiency of the medical device, executed by the Member State of the Eurasian Economic Union performing marketing authorisation procedure for the medical device

_____________________________________________________________________________

(Name of the Authorised Body (Expert Authority)
of the Recognition State)

APPROVED

(The Head of the Authorised Body

(Expert Authority)

Full name, signature, stamp)

“__” of ________, 20__

CONCLUSION

On approval (non-approval) of the expert conclusion made on the basis of the expert assessment of the safety, quality and efficiency of a medical device provided by the Member State of the Eurasian Economic Union performing the marketing authorisation procedure for a medical device

No. “__” of ________, 20__

1. Name of the Authorised Body (Expert Authority) of the member State of the Eurasian Economic Union providing the marketing authorisation of the medical device in question (hereinafter the Reference State)
2. Date of posting of the expert conclusion in the information system of the Authorised Body (expert Authority) of the Reference State.
3. Ref. number of the expert conclusion
4. Name of the medical device (along with the accessories required for operation of the medical device as intended)
5. Manufacturer of the medical device (full and abbreviated name, legal form of the legal entity, location, address)
6. Authorised representative of the manufacturer of the medical device (full and abbreviated name, legal form of the legal entity, location, address) (if applicable)
7. Applicant
8. Information regarding experts (full name, field of competence, academic credentials (if applicable), place of employment, title)
9. Review of the expert assessment of the safety, quality and efficiency of the medical device provided by the Authorised Body (Expert Authority) of the Reference State as the outcome of the expert assessment of the safety, quality and efficiency of the medical device in terms of completeness, quality of document review, evaluation of scope and completeness of tests and trials conducted.
11. Outcome of the expert assessment (please list conclusions on every individual aspect of the expert assessment)
12. Conclusion (the general conclusion is stated, and in the event of a negative outcome, this has to be justified)
Date of submission of the decision on approval (or non-approval) of the expert conclusion made by the Reference State on the basis of the expert assessment of the quality, safety and efficiency of the medical device
I have been informed about the responsibility to ensure the accuracy of facts provided in the decision on the approval (or non-approval) of the expert conclusion made by the Reference State on the basis of the expert assessment of the quality, safety and efficiency of the medical device.
_________________ (Full name of expert)	_____________________ (signature)

Appendix no. 7
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of the application for amendment of the marketing authorisation file of a medical device

To the Authorised Body

of the Member State

of the Eurasian Economic Union

_______________________________________

(Name of the Reference State)

_______________________________________

(Name of the Recognising State)

APPLICATION
for amendment of the marketing authorisation file of a medical device

______________________________________________________________________________

(Full and abbreviated name (if applicable), including brand name,

of the organisation on behalf of which amendments
are requested (manufacturer (authorised representative

of the manufacturer), legal form of the legal entity)

1.	Name of the medical device
2.	Manufacturer of the medical device
3.	Manufacturing country of the medical device:
4.	Authorised representative of the manufacturer (if applicable)
5.	Class of potential risk of use of the medical device
5.	Type code of the medical device (as per the Nomenclature of Medical Devices used within the Union)

hereby requests amendments to the Marketing Authorisation File

of the medical device due to the following changes implemented:

Amendments proposed to the Marketing Authorisation File
1.	Change of information related to the Applicant, including information about re-organisation of the legal entity, change of company name or individual`s name or surname and address
	Version before amendments	Amendments to be implemented
2.	Change of the name of the medical device
	Version before amendments	Amendments to be implemented
3.	Change of accessories, and/or components, and/or consumables
	Version before amendments	Amendments to be implemented
4.	Changes in indications for use, scope of application, contra-indications, adverse effects
	Version before amendments	Amendments to be implemented
5.	Changes in information about the manufacturer of the medical device
	Version before amendments	Amendments to be implemented
6.	Changes in technical and/or operational documents of the medical device
	Version before amendments	Amendments to be implemented

No amendments to be made in the Marketing Authorisation File

result in changes of the properties or features related to the safety, quality and

efficiency of the medical device.

______________________________________________________________________________

(Manufacturer of the medical device (or its authorised representative))

I guarantee that the information provided here is correct.

I guarantee that the declared safety and efficiency parameters of the medical device will be preserved and stable during the whole period of its service life, provided the conditions of storage, transportation and operation of the medical device will be in compliance with the requirements of the manufacturer.

Date of application

Full name and title of the head person

of the manufacturer (or authorised representative

of the manufacturer)

Signature and stamp of the manufacturer

(authorised person of the manufacturer)

Appendix no. 8
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

LIST
of amendments to be implemented in the Marketing Authorisation File during the validity term of the Marketing Authorisation Certificate, which do not require a new marketing authorisation procedure

Name of information to be amended	Conditions	Information and documents necessary for the implementation of the proposed amendments
1. Information related to the Applicant, including information about re-organisation of the legal entity, change of company name or individual`s name or surname and address	Amendments to the Marketing Authorisation Certificate will not affect the safety and efficiency of the medical device as per the general requirements for the safety and efficiency of medical devices, the labelling requirements and requirements for related operational documentation	copy of the document confirming the authority of the manufacturer’s authorised representative
		Marketing Authorisation File number
		documents confirming the proposed amendments
		list of documents
2. Name of the medical device	Justification of the need to change the name of the medical device which does not affect the functionality and technical parameters of the device	application for amendments as per the template provided in Appendix 7 to the Rules
		document* confirming the marketing authorisation of the medical device in the manufacturing country (Declaration of Conformity, Marketing Authorisation Certificate, Free Sales Certificate, Export Certificate etc.), with the amendments implemented
		copy of the Marketing Authorisation Certificate as per the template provided in Appendix 1 to the Rules
		letter from the manufacturer containing a reasoned justification of the need to change the name of the medical device, which does not affect the functionality and technical parameters of the medical device
		draft version of the Instructions for Use (User Guide) for the medical device
		labelling layout
		document setting out the requirements for the specifications (performance characteristics) of the medical device to which the medical device is compliant, drawn up in accordance with the new name of the medical device
		operational documentation of the manufacturer for the medical device (including the User Guide or the Instructions for Use of the medical device) drawn up in accordance with the new name of the medical device
		photographic images of the general configuration of the medical device together with the accessories needed for its intended application (Minimum 18×24 cm)
		list of documents
3. List of accessories, and/or components, and/or consumables	Proof of no effect on the functionality of the medical device	application for amendments as per the template provided in Appendix 7 to the Rules
		copy of the Marketing Authorisation Certificate as per the single template provided in Appendix 1 to the Rules
		Letter from the manufacturer, with a reasoned justification of the need to change the composition of the device, listing the new set of components and confirming no effect on the functionality of the medical device
		draft version of the Instructions for Use (User Guide) for the medical device, written in an official language of the Member State of the Eurasian Economic Union and in Russian
		updated specification stating the list of the components and consumables as per the approved form
		list of documents
		If a new component is added, which is a medical device itself, a sample of this component (in the event of a sterile component, the whole batch of samples shall be provided), along with the related regulatory documentation
4. Indications for use, scope of application, contra-indications, adverse effects	the safety of the medical device shall be preserved and shall be confirmed by the data obtained from trials, clinical safety data and quality data	application for amendments as per the template provided in Appendix 7 to the Rules
		copy of the Marketing Authorisation Certificate as per the single template provided in Appendix 1 to the Rules
		letter from the manufacturer with a reasoned justification of the need to change the Indications for Use for the medical device
		draft version of the Instructions for Use (User Guide) for the medical device
		previous version of the Instructions for Use (User Guide) for the medical device
		Full colour layouts of the packaging, labels, stickers (if necessary) (this to be provided on e-storage media (CD) in JPEG format)
		results of related clinical (medical) trials reflecting such amendments
		list of documents
5. Information about the manufacturer of the medical device	no changes in the production process or in specifications, including test methods	application for amendments as per the template provided in Appendix 7 to the Rules
		document* confirming the marketing authorisation of the medical device in the manufacturing country (Marketing Authorisation Certificate, Free Sales Certificate, Export certificate etc.), with the amendments implemented
		document* confirming implementation of amendments (stating the date of implementation)
		document* confirming compliance of the production process with national and/or international standards (GMP, ISO EN)
		document* confirming compliance of the medical device with national or international standards, and stating the potential risk class (Conformity Certificate, Declaration of Conformity)
		copy of the Marketing Authorisation Certificate as per the template provided in Appendix 1 to the Rules
		Letter from the manufacturer confirming that the production process, quality control and control of safety will remain unchanged, stating the date of implementation of the proposed amendments
		draft version of the Instructions for Use (User Guide) for the medical device
		labelling layout
		list of documents
6. The manufacturer’s specification or other specifications (if applicable), against which the compliance of the medical device is verified, and/or operational documentation of this medical device	no changes in the production process or in specifications, including test methods	application for amendments as per the template provided in Appendix 7 to the Rules
		copy of the Marketing Authorisation Certificate as per the template provided in Appendix 1 to the Rules
		manufacturer`s justification letter regarding proposed amendments
		Data regarding the stability of the medical device obtained from a minimum of 3 batches of the product (if applicable, provide also the report to justify the service life of the medical device)
		draft version of the Instructions for Use (User Guide) for the medical device (if necessary)
		full colour layouts of packaging, labels and stickers (if necessary)
		regulatory documentation* with the amendments implemented, stating the quality parameters of the final product, along with the Certificate of Analysis and methods for monitoring the final product (if necessary)
		technical test report or other relevant test (study) report containing an evaluation of the biological effect considering the amended regulatory documentation (if necessary)
		list of documents

*Documents shall be provided with mandatory authentic translation into Russian (certified by notary)

Appendix no. 9
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

EXPERT CONCLUSION
on the approval (non-approval) of amendments
to the Marketing Authorisation File for a medical device

Name of medical device.
Manufacturer, country.
Manufacturing site, country.
Scope of application, intended use.
Type of medical device as per the nomenclature of medical devices used within the Eurasian Economic Union.
Class of potential risk of use of the medical device.
Number of the Marketing Authorisation Certificate.
Date of issue of the Marketing Authorisation Certificate
Amendments to be implemented.

Type of amendments to be implemented	Data included in the MAF at the moment of registration	Amendments to be implemented	Applicant`s justification of proposed amendments
1. Change of the manufacturer’s name, manufacturing site(s), for the whole process or for part of it
2. Change of the name of the medical device
3. Change of accessories, components, and/or consumables
4. Changes in indications for use, scope of application, contra-indications, adverse effects
5. Changes in information about the manufacturer of the medical device
6. Changes in the manufacturer’s specification or other specifications (if applicable), against which the compliance of the medical device is verified, and/or operational documentation of this medical device

Analysis and evaluation of data justifying the amendments
Analysis of risks related to the implementation of amendments (conclusion on the possible risks associated with the proposed amendments)
Conclusion on the recommendation (or non-recommendation) to accept the proposed amendments.
Full name, academic credentials (title) (if applicable), signature of the expert involved in this conclusion.
Date of the report’s completion.
Signature of the Head of the Expert Authority.
Stamp of the expert authority.

Appendix no. 10
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of the application for cancellation (withdrawal)
of the Marketing Authorisation Certificate for a medical device

(on the official headed paper of the organisation)

To the Authorised Body of the Reference State

APPLICATION

for cancellation (withdrawal) of the Marketing Authorisation Certificate

for a medical device

_________________________________________________________________________

(Full and abbreviated name (if applicable), name of the applicant,

including brand name, legal form of the legal entity)

_________________________________________________________________________________________________________________________________

Hereby requests to cancel the Marketing Authorisation Certificate

(To withdraw the marketing Authorisation Certificate) for the medical device

(Name of the medical device (along with the related accessories

necessary for the intended use of the medical device))

_________________________________________________________________________________________________________________________________

Date of the marketing authorisation of the medical device and number
of the related Marketing Authorisation Certificate

due to___________________________________________________________________ _

(Please state the reason)

_________________________________________________________________________________________________________________________________

(Full name of the head person of the manufacturer of the medical device

(or its authorised representative))

“__” of ________, 20__.place of stamp ______________________________

(signature)

Appendix no. 11
to the Rules for the Marketing Authorisation and Expert
Assessment of the Safety, Quality and Efficiency
of Medical Devices

TEMPLATE
of the application for issuing a duplicate of the existing Marketing Authorisation Certificate
for a medical device

(on the official headed paper of the organisation)

To the Authorised Body of the Reference State

APPLICATION
for issuing a duplicate of the existing
Marketing Authorisation Certificate for a medical device

1. Name of the medical device (along with the related accessories necessary for its intended use, as an addendum to the application, certified by the signature and stamp of the head person)
I. In relation to the manufacturer of the medical device
2. Legal form and full name of the legal entity
3. Abbreviated name of the legal entity (if applicable)
4. Brand name of the legal entity (if applicable)
5. Location (address) of the legal entity
6. Phone number
7. E-mail address of the legal entity (if applicable)
8. Tax payer identification number
II. In relation to the authorised representative of the manufacturer
9. Legal form and full name of the legal entity
10. Abbreviated name of the legal entity (if applicable)
11. Brand name of the legal entity (if applicable)
12. Location (address) of the legal entity
13. Phone number
14. E-mail address of the legal entity (if applicable)
15. Tax payer identification number
16. Place of manufacture of the medical device:
17. Intended use of the medical device, as established by the manufacturer
18. Type of medical device as per the nomenclature of medical devices used within the Eurasian Economic Union
19. Class of medical device in accordance with the rules of the classification of medical devices depending on the potential risk of usage
20. Method of obtaining information related to the marketing authorisation procedure for the medical device
21. Method of obtaining the Marketing Authorisation Certificate	In hard copy, delivered personally
	In hard copy, delivered by registered mail with a return receipt requested
	In the form of an electronic document
	Other
22. Reason for issuing the duplicate
23. Information regarding payment of the state fee (Provided at the discretion of the Applicant):
Date and number of the payment order

________________________________________________________________________

Full name of the head person of the manufacturer of the medical device (or its authorised representative))

“__” of ________, 20__.place of stamp ________________________________

(signature)

Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, No. 46 “On the Rules for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices

Rules for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices(as approved by the Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, no. 46)

I. General Provisions

II. Procedures for the Marketing Authorisation and Expert Assessment of a Medical Device

III. Procedure of agreement of the expert conclusion

IV. Expert review of amendments made to the Marketing Authorisation File

V. Procedure for the suspension or cancellation of a Marketing Authorisation Certificate

VI. Procedure for Issuing a Duplicate of an existing Marketing Authorisation Certificate

TEMPLATE of a Marketing Authorisation Certificate and rules for its issue

II. I. Rules for issuing the Marketing Authorisation Certificate

TEMPLATE of an Application for Expert Assessment of a Medical Device

TEMPLATE of an Application for the Marketing Authorisation of a Medical Device

THE LIST of documents necessary for the marketing authorisation of a medical device, and template of the reference statement for the medical device

Reference statement for the medical device

EXPERT CONCLUSION on the assessment of the safety, efficiency and quality of medical devices as part of marketing authorisation

TEMPLATE of the application for amendment of the marketing authorisation file of a medical device

APPLICATION for amendment of the marketing authorisation file of a medical device

LIST of amendments to be implemented in the Marketing Authorisation File during the validity term of the Marketing Authorisation Certificate, which do not require a new marketing authorisation procedure

EXPERT CONCLUSION on the approval (non-approval) of amendments to the Marketing Authorisation File for a medical device

TEMPLATE of the application for cancellation (withdrawal) of the Marketing Authorisation Certificate for a medical device

TEMPLATE of the application for issuing a duplicate of the existing Marketing Authorisation Certificate for a medical device

APPLICATION for issuing a duplicate of the existing Marketing Authorisation Certificate for a medical device

I. In relation to the manufacturer of the medical device

II. In relation to the authorised representative of the manufacturer

Rules
for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices(as approved by the Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, no. 46)

TEMPLATE
of a Marketing Authorisation Certificate and rules for its issue

TEMPLATE
of an Application for Expert Assessment of a Medical Device

TEMPLATE
of an Application for the Marketing Authorisation of a Medical Device

THE LIST
of documents necessary for the marketing authorisation of a medical device, and template of the reference statement for the medical device

EXPERT CONCLUSION
on the assessment of the safety, efficiency and quality of medical devices
as part of marketing authorisation

TEMPLATE
of the application for amendment of the marketing authorisation file of a medical device

APPLICATION
for amendment of the marketing authorisation file of a medical device

LIST
of amendments to be implemented in the Marketing Authorisation File during the validity term of the Marketing Authorisation Certificate, which do not require a new marketing authorisation procedure

EXPERT CONCLUSION
on the approval (non-approval) of amendments
to the Marketing Authorisation File for a medical device

TEMPLATE
of the application for cancellation (withdrawal)
of the Marketing Authorisation Certificate for a medical device

TEMPLATE
of the application for issuing a duplicate of the existing Marketing Authorisation Certificate
for a medical device

APPLICATION
for issuing a duplicate of the existing
Marketing Authorisation Certificate for a medical device