
Resolution No. 552 of 01.04.2022
GOVERNMENT OF THE RUSSIAN FEDERATION
RESOLUTION
dated 01 April 2022 No. 552
MOSCOW
On the approval of specific features of the circulation, including specific features pertaining to the marketing authorisation, of medical devices in the event of deficiency or risk of possible deficiency which may occur due to the implementation of restrictive economic measures with regard to the Russian Federation
In accordance with part 51 of Article 38 of the Federal Law “On the Basics of Public Healthcare in the Russian Federation”, item 3 of part 1 of article 18 of the Federal Law dated March 8, 2022 No. 46-FZ “On the implementation of changes in certain regulations of the Russian Federation”, the Government of the Russian Federation hereby orders the following:
1.Approve the attached specific features of the circulation, including specific features pertaining to the marketing authorisation, of medical devices in the event of defects or risks of possible defects which may occur due to the implementation of restrictive economic measures with regard to the Russian Federation
2.An Expert Review of the application for the marketing authorisation of a medical device and related documents provided in accordance with the Rules for the Marketing Authorisation of Medical Devices as approved by an order of the Government of the Russian Federation dated 27 December 2012, no. 1416 “On the Approval of the Rules for the Marketing Authorisation of Medical Devices”, shall be conducted, starting from the Effective Date of the order, simultaneously with the expert review of the completeness and results of the performed technical tests, toxicological studies, clinical studies, as well as any tests performed in order to get approval for the measurement devices (for medical devices considered as measurement devices within the scope of state regulation of the assurance of measurement uniformity, the list of which devices have to be approved by the Ministry of Healthcare of the Russian Federation), with the exception of tests requiring clinical human-based studies.
3.This order comes into full force on the day of its official publication, and shall remain in force until 1 September, 2023.
STAMP: STATE ADMINISTRATION OF RUSSIAN FEDERATION DEPARTMENT OF DOCUMENT SUPPORT OF THE GOVERNMENT OF RUSSIAN FEDERATION 8 NO.1/
Chairman of the Government of the Russian Federation |
M. Mishustin |
APPROVED by Resolution of the Government of the Russian Federation dated 01 April 2022 no. 552 |
SPECIFIC FEATURES
of the circulation, including specific features pertaining to the marketing authorisation, of medical devices in the event of defects or risks of possible defects which may occur due to the implementation of restrictive economic measures with regard to the Russian Federation
І. General terms
1.This document is related to the implementation of restrictive economic measures with regard to the Russian Federation and determines specific features of the circulation of medical devices, particularly considering specific features of the marketing authorisation of medical devices, implementation of changes in the documentation pertaining to the registration dossier for a domestic medical device (a medical device mentioned in the marketing authorisation certificate issued as per this document or as per the Rules for the Marketing Authorisation of Medical Devices, as approved by Order of the Government of the Russian Federation dated 27 December 2012, no. 1416 “On Approval of the Rules for the Marketing Authorisation of Medical Devices” (hereinafter “Rules for the Marketing Authorisation”), or a medical device, of which the manufacturer stated in the MA application is the legal entity or physical person, a resident of the Russian Federation, registered as an individual entrepreneur and having a manufacturing location (manufacturing site) within the territory of the Russian Federation (hereinafter the domestic medical device).
2.The Marketing Authorisation of Medical Devices in accordance with this document is performed by the Federal Service for Surveillance in Healthcare (hereinafter — registering body).
3.The fact of the marketing authorisation in accordance with this document has to be confirmed by the Marketing Authorisation Certificate issued with the validity term until 1 September 2023, and by the registration entry in the State Register of Medical Devices and Organisations (Individual Entrepreneurs) performing the manufacture and production of medical devices (hereinafter the State Register).
A counteract of the Marketing Authorisation Certificate for the medical device shall be issued as per the procedure outlined in the Rules for the Marketing Authorisation.
4.The list of types of medical devices to be allowed for circulation under this document (hereinafter the List of Medical Devices) has to be approved by the intergovernmental committee comprising representatives of the Ministry of Healthcare of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finances of the Russian Federation, the Ministry of Economic Development of the Russian Federation, the Federal Anti-Monopoly Service, the Federal Customs Service, the Federal Tax Service, the registering body, and representatives of other authorities and organisations, if necessary (hereinafter the Intergovernmental Committee).
The Provisions on the Intergovernmental Committee, including the procedure for the organisation of its operations, the procedure for the determination of the deficiency of medical devices or risk of potential deficiency, the criteria for the inclusion of a medical device in the List of Medical Devices, and the composition of the Intergovernmental Committee, shall be approved by the Registering Body on agreement with the Ministry of Healthcare of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finances of the Russian Federation, the Ministry of Economic Development of the Russian Federation, and the Federal Anti-Monopoly Service.
The List of Medical Devices includes:
medical devices under deficiency or under risk of such deficiency;
medical devices for which the Intergovernmental Committee received proposals for the delivery of such medical devices at the price below the average market rate;
other medical devices as per the decision of the Intergovernmental Committee.
The List of Medical Devices has to be posted on the official site of the Registering Body in the information and telecommunications network the Internet (hereinafter “the Internet network”) within a maximum of two working days upon its approval (or modification) by the Intergovernmental Committee.
5.For the purposes of this document, the following definitions are used:
“Applicant” means the producer (manufacturer) of the medical device concerned, or the authorised representative of the producer (manufacturer), or importer of the medical device concerned to the Russian Federation with the intention of its marketing authorisation.
“Importer of the medical device concerned to the Russian Federation with the intention of its marketing authorisation” means the legal entity or physical person registered as an individual entrepreneur, with the status of a resident of the Russian Federation, responsible for all issues related to the circulation of the medical device concerned, and performing the procurement, storage, formation of batches without any effect on the quality of the product, or the sale of the product without any effect on its quality.
“Manufacturing Site” means the physically localised facility intended for the performance of the entire process of the manufacturing of the medical device, or for the performance of certain stages of that process.
Other definitions used in that document are used in their respective meanings determined by the Rules for the MA.
6.The State Marketing Authorisation of medical devices with low potential risk associated with their application (except medical devices produced as sterile units), which are included in the List of Medical Devices, has to be performed as per the Applicant’s choice in accordance with paragraphs 13–22 of this document, or in accordance with paragraphs 23–29 of this document.
7.Cancellation of the Marketing Authorisation for the foreign medical device registered in accordance with the Rules for the MA or with this document for the consumables concerned on the basis of the application of the producer (manufacturer) of the medical device concerned, or the authorised representative of the producer (manufacturer) of the medical device for cancellation of the Marketing Authorisation for the medical device concerned is not performed.
8.The Federal Budgetary Enterprises reporting to the Registering Body (hereinafter the Expert Authority), may, upon the request of the Applicants, before the start of the Marketing Authorisation procedure, provide on a payment basis consultancy services related to the Marketing Authorisation of medical devices, including a preliminary review and evaluation of the registration dossier.
The consultancy services mentioned in the first paragraph of this item are not a mandatory condition for receiving the state service of the Marketing Authorisation.
9.In order to comply with the principles of non-prejudice and independence of the expert review of the quality, efficiency and safety of the medical device, and in order to avoid a possible conflict of interest, the officers of the Expert Authorities performing consultancy services as per clause 8 of this document, cannot be involved in the expert review of the quality, efficiency and safety of the medical device concerned.
10.During the circulation of the medical devices, both included and not included in the List of Medical Devices, it is not allowed to limit their interchangeability by means of using specific hardware or software means, or by any other means.
11.It is possible to use the medical device, for which the producer (manufacturer) is established in the operational documentation as a limited list of consumables, in combination with the consumables of another producer (manufacturer) registered as a medical device, provided the aforementioned producer (manufacturer) has confirmed for those consumables during the process of the Marketing Authorisation the possibility of combined use with the medical device concerned. Such combined use of the medical device and consumables shall be performed with consideration of certain features specified in the operational documentation of the producer (manufacturer)
12.The State Fee due to the Registering Body for its operations related to the Marketing Authorisation has to be paid in accordance with the applicable tax and fee legislation of the Russian Federation.
II. The specific features of the marketing authorisation of medical devices included in the List of Medical Devices
13.For the purposes of the Marketing Authorisation, the Applicant shall submit the following information and documents in paper format:
application for the Marketing Authorisation of the medical device, issued in accordance with the requirements for the contents and form of such application, as set forth in the Rules for the MA;
a copy of the document confirming the authority of the producer’s (manufacturer’s) authorised representative;
the original document confirming the authority of the importer of the medical device concerned to the Russian Federation with the intention of its Marketing Authorisation (as applicable);
documents confirming that the medical device concerned belongs to the importer of the device to the Russian Federation with the intention of its legal Marketing Authorisation (as applicable);
technical documentation of the producer (manufacturer) for the medical device in question, drawn up in accordance with the requirements of the Ministry of Healthcare of the Russian Federation;
operational documentation of the producer (manufacturer) for the medical device in question, drawn up in accordance with the requirements of the Ministry of Healthcare of the Russian Federation;
photographic images of the general configuration of the medical device together with the accessories needed for its intended application (minimum size 18 x 24 cm);
photographic images of the electronic media and interface of the software (if any) (minimum size 18 x 24 cm), for the software which isconsidered as a medical device, including the software based on the AI technologies;
documents supporting the results of technical tests of the medical devices, toxicological tests of the medical device and (or) accessories related to the medical device concerned which are directly or indirectly in contact with the human body, its mucous membranes, body fluids, etc., for which the aforementioned contact is necessary for the performance of their essential functions (hereinafter the Test), clinical trials of the medical device performed as per a standard test program depending on the type of medical device concerned, developed by the Expert Authorities (hereinafter the Standard Program) and published on the official site of the Expert Authority in the Internet network (as applicable), or in the form of the evaluation of compliance of the medical devices in the form of technical tests, toxicological studies, clinical trials, in order to obtain the Marketing Authorisation as per the procedure provided by the Ministry of Healthcare of the Russian Federation.
The clinical trials as per the Standard Program shall be conducted within the qualified laboratory (center), as part of the national accreditation system, conducting technical tests and/or toxicological trials, with consideration of the scope of accreditation, and also in the medical organization compliant with the requirements set forth by the Ministry of Healthcare of the Russian Federation, and capable of conducting clinical trials of medical devices.
For Domestic Medical Devices (except implanted medical devices and sterile medical devices), for the purpose of the Marketing Authorisation it is possible to submit the producer’s (manufacturer’s) documentation and/or documentation provided by organizations performing technical tests or toxicological studies (with the results of related tests) which allow evaluation of the methods (techniques) used and the list of test equipment used (at the Applicant’s discretion).
For Foreign Medical devices (except the software constituting the medical device itself, including the software using artificial intelligence technologies and medical devices intended for in vitro diagnostics), for the purpose of the Marketing Authorisation, copies of the documents confirming the fact of marketing authorisation in the country of origin, together with the documents confirming the clinical efficiency and safety of the medical device concerned shall be provided, and exact composition is at the discretion of the Applicant. In that case, the results of clinical trials of the medical device concerned performed within the territory of the Russian Federation in accordance with the procedures set forth by the Ministry of Healthcare of the Russian Federation shall not be submitted;
documents confirming the findings of tests of the medical device in order to approve the type of measuring instruments (with regard to medical devices related to measuring instruments in the field of the state regulation of traceability, the list of which is approved by the Ministry of Healthcare of the Russian Federation).
information concerning import licenses issued by the Registering Body with the purpose for the Marketing Authorisation of the medical devices concerned (for medical devices manufactured by the legal entity or physical person registered as an individual entrepreneur on the territory of the Russian Federation, while the address(es) of the manufacturing site(s) for such medical devices are within the territory of a foreign country, and for Foreign Medical Devices, except the software constituting the medical device itself, including the software using artificial intelligence technologies);
documents confirming the possibility of manufacturing at the address(es) stated in the application for the Marketing Authorisation of the medical device concerned (manufacturing site(s) (documents confirming related manufacturing capacities, and/or copies of QMS certificates as per the requirements of GOST ISO 13485. “Medical devices. Quality management systems. Requirements for regulatory purposes” or related international standard ISO 13485 (if applicable);
any other documents supporting the quality, efficiency and safety of the medical device concerned (if any);
list of documents referring to the Section of this document regulating the procedure for the Marketing Authorisation for the medical device concerned.
When the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.
The producer’s (manufacturer’s) documents mentioned in this clause (except for the document mentioned in paragraph 3 of this clause) shall be certified by the producer (manufacturer) or authorised representative of the producer (manufacturer), provided there is a document confirming the authority of the aforementioned representative of the producer (manufacturer) regarding such certification of documents, which shall be issued and enter into full force before the issuing of the documents mentioned in this clause.
14.Upon receipt of the documents mentioned in clause 13 of this document, the Expert Authority shall, within 15 working days, evaluate the dossier submitted for its correctness and accuracy, completeness and sufficiency, including the adequacy of the scope of tests and studies (trials) performed against the requirements of the marketing authorisation of the medical device in accordance with this document, and therefore draw an expert conclusion on the possibility of the marketing authorisation (or rejection statement, if applicable) of the medical device, as per the form approved by the Ministry of Healthcare of the Russian Federation, with the purpose of the expert evaluation of the quality, safety and efficiency of the medical device in question, and shall submit this conclusion/statement to the related Registering Body.
Such conclusion/statement of the Expert Authority shall be accompanied with the dossier submitted by the Applicant as per paragraph 13 of this document.
15.In the event that it is insufficient for the Expert Authority to make a conclusion (as per clause 14 of this document) on the materials and information contained in the documents submitted by the Applicant, as stipulated by clause 13 of this document, the expert institution shall send the Applicant within 5 business days a request for submission of the necessary information indicating the nature of the comments and how to address them by recorded delivery or in the form of an electronic document signed by electronic signature or delivered via telecommunication channels (hereinafter — the Request).
The Applicant must submit a response to the request of the expert institution within a period not exceeding 30 business days from the date of submission of the Request. The expert institution shall prepare a report within 5 business days of receiving a response to the Applicant’s request.
In the event of failure to submit a response to the Request after 30 business days, the expert institution shall prepare a report on the basis of documents available.
16.The rejection statement for the marketing authorisation of the medical device may be completed by the Expert Authority when one or several of the following conditions occur:
a) there is no evidence of compliance of the medical device concerned with the requirements set forth in the producer’s (manufacturer’s) documentation;
b) here is no evidence of the quality and /or efficiency, and/or safety of the medical device concerned;
c) the risk of damage to the health of patients and medical practitioners associated with the use of the medical device concerned outweighs the related benefits;
d) the medical device is not listed in the List of Medical Devices;
e) documents mentioned in clause 13 of this document are not provided fully, including those mentioned in clause 15 of this document, and/or there are some invalid or incorrect facts mentioned in those documents.
17.The Registering Body, within 7 working days of receipt of the aforementioned statement/conclusion as per clause 14 of this Statement, shall either:
a) take a decision on the Marketing Authorisation of the medical device or the refusal to carry out the Marketing Authorisation of the medical device, which is formally issued as an order by the Registering Body, and notification to the applicant of the decision taken with a related record made in the State Registry regarding the authorised medical device;
b) issuing and release to the user of the Marketing Authorisation Certificate or notification of the rejection of the SMA for the medical device concerned, stating the reasons of such rejection.
18.As for the medical devices included into the List of Medical Devices changes in the documents constituting registration dossier are allowed, for the reasons provided in the Rules for the Marketing Authorisation, which do not require an expert review of the quality, efficiency and safety of the medical device concerned, and in the event when changes are related to the information about the importer of the medical device into the territory of the Russian Federation with the purpose of Marketing Authorisation.
Any modifications or changes to the documents constituting the registration dossier for the medical device registered as per this document, which require an expert review of the quality, efficiency and safety of the medical device concerned, shall be performed as per the procedure provided in the Rules for the Marketing Authorisation, within 25 working days after receiving a notification on such modification or change and submission of the related documents package, as required by the Rules for the Marketing Authorisation.
19.In order to implement modifications and changes in the documents constituting the registration dossier, as mentioned in the paragraph 1 of clause 18 of this document, the Applicant has to submit directly to the Registering Body or send by registered mail with delivery notification and list of the contents, the following documents in paper format:
an application for amending the documents contained in the registration dossier (hereinafter the Application for Making Amendments), carried out in accordance with the requirements for the content of such Application for Making Amendments as set forth in the Rules for the Marketing Authorisation;
a copy of the document confirming the authority of the producer’s (manufacturer’s) authorised representative;
the original document confirming the authority of the importer of the medical device concerned to the Russian Federation with the intention of its Marketing Authorisation;
documents confirming that the medical device concerned belongs to the importer into the Russian Federation with the intention of its legal Marketing Authorisation;
documents confirming the possibility of manufacturing at the address(es) stated in the Application for Making Amendments (manufacturing site(s) (documents confirming related manufacturing capacities, and/or copies of QMS certificates as per the requirements of GOST ISO 13485. Medical devices. Quality management systems. Requirements for regulatory purposes”, or Related international standard ISO 13485 (if applicable), documents and information on related amendments and modifications, including
documents confirming amendments and modifications and supporting the fact that such amendments and modifications will not result in a change of the characteristics and properties of the medical device related to its safety, quality and efficiency under the same intended function and/or functional concept;
original of the registration certificate (duplicate);
information concerning import licenses issued by the Registering Body with the purpose of the Marketing Authorisation of the medical devices concerned (for medical devices manufactured by the legal entity or individual entrepreneur registered in the territory of the Russian Federation, while address(es) of manufacturing site(s) for such medical devices are within the territory of a foreign country, and for Foreign Medical Devices, except the software constituting the medical device itself, including the software using artificial intelligence technologies);
list of documents referring to the Section of this document regulating the procedure for the Marketing Authorisation for the medical device concerned.
If the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.
The producer’s (manufacturer’s) documents mentioned in this clause (except for the document mentioned in paragraph 3 of this clause) shall be certified by the producer (manufacturer) or authorised representative of the producer (manufacturer), provided there is a document confirming the authority of the aforementioned representative of the producer (manufacturer) regarding such certification of documents, which shall be issued and enter into full force before the issuing of the documents mentioned in this clause.
20.Within 15 working days after receiving the Application on Making Amendments, and submitting the documents as per clause 19 of this document, the Registering Body shall review the completeness and accuracy of all information contained in the documents concerned, and shall either:
а) take a decision on amending the documents contained in the registration dossier, which is drawn up on the order of the Registering Body entering the relevant information in the State Registry, or a decision to return the application for amendments and documents referred to in clause 19 hereof, indicating the reasons for their return;
b) send a written notification to the Applicant on the decision made by recorded delivery enclosing the renewed registration certificate (in the event of making amendments to it) and the previously issued registration certificate with an indication of its invalidity (indicating the date).
21.The Registering Body shall create a registration dossier for the medical device concerned comprising of the following documents:
a) application for Marketing Authorisation with related documents, and an Application for Making Amendments with supporting documents;
b) the expert conclusion of the Expert Authority on the possibility of the marketing authorisation of the medical device concerned (either positive or negative);
c) the related decision on the Marketing Authorisation of the medical device concerned, with the issuing of the appropriate order by the Registration Body;
d) a copy of the registration certificate and notices issued by the Registration Body;
e) a copy of the duplicate registration certificate issued by the Registration Body.
22.During the term of validity of the Marketing Authorisation of the medical device carried out in accordance with this document, the producer (manufacturer) of the medical device or the authorised representative of the producer (manufacturer) of the medical device has the right to submit to the Registering Body the Application for Marketing Authorisation and the package of documents as per the Rules for the Marketing Authorisation, in order to pass the procedure for the Marketing Authorisation with the subsequent issuing of a permanent MA certificate.
In order to provide the Marketing Authorisation of the medical device, the Expert Review of the Application for the Marketing Authorisation, and the documents required as per the Rules for the MA, shall be performed simultaneously with the Expert Review of the completeness and results of the tests and studies conducted.
III.Specific features of the Marketing Authorisation of medical devices with low risks associated with their application (except for medical devices produced as sterile items) included in the List of Medical Devices
23.For the purposes of the Marketing Authorisation of a medical device with low risk associated with its usage (except medical devices produced as sterile items) included in the List of Medical Devices, the Applicant shall submit directly to the Registering Body or send by registered mail with delivery notification and list of the contents, the following documents in paper format:
application for the Marketing Authorisation of the medical device, issued in accordance with the requirements for the contents and form of such application, set forth in the Rules for the MA;
a copy of the document confirming the authority of the producer’s (manufacturer’s) authorised representative;
the original document confirming the authority of the importer into the Russian Federation of the medical device concerned with the intention of its Marketing Authorisation (as applicable);
documents confirming that the medical device concerned belongs to the importer into the Russian Federation with the intention of its legal Marketing Authorisation (as applicable);
technical documentation of the producer (manufacturer) for the medical device in question, drawn up in accordance with the requirements of the Ministry of Healthcare of the Russian Federation;
operational documentation of the producer (manufacturer) for the medical device in question, drawn up in accordance with the requirements of the Ministry of Healthcare of the Russian Federation;
photographic images of the general configuration of the medical device together with the accessories needed for its intended application (minimum size 18 x 24 cm);
photo of the electronic media and interface (if applicable, minimum size 18 x 24 cm), for the software which is considered as a medical device;
list of documents referring to the Section of this document regulating the procedure for the Marketing Authorisation for the medical device concerned.
When the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.
The producer’s (manufacturer’s) documents mentioned in this clause (except for the document mentioned in paragraph 3 of this clause) shall be certified by the producer (manufacturer) or authorised representative of the producer (manufacturer), provided there is a document confirming the authority of the aforementioned representative of the producer (manufacturer) regarding such certification of documents, which shall be issued and enter into full force before the issuing of the documents mentioned in this clause.
24.Within 5 working days after receiving the Application and related documents package mentioned in clause 23 of this document the Registering Body has to take a decision on the Marketing Authorisation issued in the form of an order by the Registering Body, and sends the MA certificate for the medical device concerned to the Applicant using registered mail with notification of delivery, or in e-form with an e-signature via telecommunication channels, and makes the related entry in the State Registry concerning the medical device in question.
When the Application for the Marketing Authorisation of the medical devices with low risk associated with its usage (except for medical devices produced as sterile items), included in the List of Medical Devices, and/or documents required under clause 23 of this document, are not submitted in their full required scope, such application and related documents will not be accepted by the Registering Body and shall be returned to the Applicant.
25.The Applicant shall within the 5 working days after receiving the MAC for the medical device with the low risk associated with its usage (except the medical devices produced as sterile items), in accordance with the previously entered agreement, provide to the Federal State Budgetary Enterprise “Russian Scientific Research and Test Institute of Medical Equipment” of the Federal Service for Surveillance in Healthcare (hereinafter the Enterprise) a sample (samples) of the medical device concerned with the purpose of carrying out the necessary tests, and pay for those services.
26.The Enterprise shall, within a maximum of 50 days upon receiving the sample (samples) of the medical device with low risk associated with its usage (except for medical devices produced as sterile items), conduct all necessary tests as per the Standard Program depending on the type of medical device concerned, as developed by the Expert Authority and published on its official site in the Internet network (as applicable), and perform the following actions:
a) issue and release to the Applicant the statement of the evaluation of the test results and the conclusion on the results of toxicological studies of the medical device concerned (as applicable);
b) send the statement of the evaluation of the test results and the conclusion on the results of toxicological studies of the medical device concerned (as applicable) to the Registering Body, attaching the accompanying letter stating information regarding any findings (or lack thereof) representing a hazard to the life and health of individuals and healthcare professionals during the operation and application of the aforementioned medical device.
27.Within a maximum of 150 working days after the date of the Marketing Authorisation of the medical device with low risk associated with its usage (except medical devices produced as sterile items), included in the List of Medical Devices, the producer (manufacturer) of the medical device or authorised representative of the producer (manufacturer) of the medical device shall submit to the Registering Body an Application for the Marketing Authorisation and the package of documents as per clause 26 of this Document, if there are no amendments or extra tests assumed, as per the requirements of the Rules for the MA, for the procedure for the Marketing Authorisation of the medical device in accordance with the Rules for the Marketing Authorisation.
With the purpose of the Marketing Authorisation of medical devices mentioned in paragraph 1 of this clause, the Expert Review of the Application for the Marketing Authorisation and documents provided in accordance with the Rules for the Marketing Authorisation, shall be performed simultaneously with the Expert Review of the completeness and results of the tests performed.
Issuing the counterpart of the SMA certificate for a medical device with low risk associated with its usage (except for medical devices produced as sterile items), included in the List of Medical Devices, shall be performed for the original copy of the MA certificate issued by the Registering Body as per the Rules for the MA.
28.Any amendments to the documents comprising the registration dossier of the medical device with low risk associated with its usage (except for medical devices produced as sterile items), included in the List of Medical Devices, shall be made after the decision taken on the fact of the Marketing Authorisation in accordance with the Rules for the MA.
29.The basic reasons for the decision by the Registering Body on the cancellation of the Marketing Authorisation of a medical device with low risk associated with its usage (except medical devices produced as sterile items), included in the List of Medical Devices are as follows:
a) an opinion drawn up by the Expert Authority, based on the results of the expert evaluation of the quality, efficiency and safety of the medical device, stating that the quality and/or efficiency and/or safety of the medical device in question is not supported by the available data, and/or an opinion stating that the risk of harm to the patient and medical professionals caused by the use of the medical device in question outweighs the beneficial effect of its usage, and/or an opinion stating that the medical device in question does not comply with the applicable regulations, technical documentation or operational instructions of the producer (manufacturer);
b) based on the results of the state monitoring of the circulation of medical devices, identification by the Registering Body of inconsistencies in the data on the efficiency and safety of the medical device with the data on the medical device contained in the documents specified in clause 23 of this document;
c) failure to provide by the producer (manufacturer) of the medical device or by the authorised representative of the producer (manufacturer) of the medical device within a term not exceeding 150 working days starting from the date of the Marketing Authorisation of the medical device with low risk associated with its usage (except medical devices produced as sterile items), included in the List of Medical Devices, the Application for the Marketing Authorisation, to the Registering Body, with the package of documents required by the Rules for the Marketing Authorisation with the purpose of passing the procedure for the Marketing Authorisation in accordance with the Rules for the Marketing Authorisation;
d) receiving information from the Enterprise about facts AND CIRCUMSTANCES CREATING HAZARDS TO THE LIFE AND HEALTH OF INDIVIDUALS AND healthcare professionals during the operation and application of the medical device concerned on the basis of results of the tests performed in accordance with clause 26 of this document;
e) failure to follow the requirements set forth in clause 25 of this document, and failure to enter into an agreement as stipulated by clause 25 of this document;
f) decision made by the Registering Body about the return of documents as per the Rules for the Marketing Authorisation.
IV.Specific features of the implementation of amendments to documents comprising the registration dossier for the medical device of the domestic origin
30.Amendments made to the documents comprising the registration dossier for the medical device of domestic origin which had successfully passed the procedure for the Marketing Authorisation as per this document, or with the Rules for the Marketing Authorisation, which require an expert review of the quality, efficiency and safety of a medical device, are generally as follows:
a) information regarding purchased products, raw materials and components;
b) information on components, spare parts and accessories.
31.To have the documents contained in the registration dossier amended with the changes specified in clause 30 of these Rules, the Applicant shall, no later than within 30 business days following the day of making the appropriate amendments, send in paper format to the Registering Body, or submit the following documents to the Registering Body via registered mail with notification on delivery and the list of contents:
the Application for Making Amendments to the documents, issued in accordance with the requirements for the contents and form of such Application, as set forth in the Rules for the MA;
a copy of the document confirming the authority of the producer’s (manufacturer’s) authorised representative;
documents and information regarding the related amendments, including documents confirming amendments and modifications and supporting the fact that such amendments and modifications will not result in a change in the characteristics and properties of the medical device related to its safety, quality and efficiency under the same intended function and/or functional concept;
original of the registration certificate (duplicate);
documents of the manufacturer and (or) organisations conducting technical tests, toxicity studies, clinical trials (results of relevant tests) confirming that the aforementioned amendments do not entail changes in the properties and characteristics affecting the quality, efficiency and safety of the medical device or improve the properties and characteristics preserving the same functional purpose and (or) the principle of the operation of the medical device;
a list of documents referring to the Section of this document regulating the procedure for making amendments to the documents comprising the registration dossier.
When the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.
32.The Expert Review of the quality, efficiency and safety of the medical device for the reasons mentioned in clause 30 of this document shall be performed within 5 working days after receiving the related task and the documents mentioned in clause 31 of this document by the Expert Authority or Registering Body.
33.The Registering Body shall, within 7 days after receiving the
a) conclusion by the Expert Authority on the possibility of amendments to the documents comprising the registration dossier of the medical devices, takes a decision to approve the amendments to the documents comprising the registration dossier, makes an entry in the related State Registry and sends notification to the applicant of the decision by registered mail with notification of delivery, or as soft copy signed with an electronic signature or in electronic form via telecommunication channels;
b) conclusion by the Expert Authority on the impossibility of amending the documents comprising the registration dossier of the medical device, takes a decision on the rejection of the amendments to the documents comprising the registration dossier, and sends notification to the applicant of the decision by registered mail with notification of delivery or as soft copy signed with an electronic signature or in electronic form via telecommunication channels