Order No. 135 by the Ministry of Health of the Russian Federation

Decree No. 135 of the Government of the Russian Federation dated 09/02/2022 (as amended on 29/12/2022)
“On the approval of the rules for the organization and implementation of inspection of the production of medical devices for compliance with the requirements for implementation, maintenance and evaluation of the quality management system for medical devices, depending on the potential risk of their use”

GOVERNMENT OF THE RUSSIAN FEDERATION DECREE No. 135dated 09 February 2022 

ON THE APPROVAL OF THE RULES FOR THE ORGANIZATION AND IMPLEMENTATION OF INSPECTION OF THE PRODUCTION OF MEDICAL DEVICES FOR COMPLIANCE WITH THE REQUIREMENTS FOR IMPLEMENTATION, MAINTENANCE AND EVALUATION OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES, DEPENDING ON THE POTENTIAL RISKOF THEIR USE 

List of amending documents

(As per Decree No. 2517 of the Government of the Russian Federation dated 29/12/2022)

In accordance with part 8.1 of Article 38 of the Federal Law “On the Fundamentals of the Healthcare of Citizens in the Russian Federation” the Government of the Russian Federation decrees:

1. Approve the attached Rules for the organization and implementation of inspection of the production of medical devices for compliance with the requirements for implementation, maintenance and evaluation of the quality management system for medical devices, depending on the potential risk of their use.

2. It shall be established that:

a) During the period from 1 January, 2023 through 31 December, 2023 evaluation of the quality management system of the manufacturer of medical device for compliance with the requirements for implementation, maintenance and evaluation of the quality management system depending on the potential risk of their use is not mandatory and may be performed on a voluntary basis, if initiated by the manufacturer of the medical device or by a representative person of the manufacturer (maker) of such medical device.

b) If no evaluation of the quality management system of the manufacturer of the medical devices was performed during the period from 1 January 2023 through 31 December 2023, then if the manufacturer of the medical device or its authorized representative shall submit during the said period of time an application for marketing authorization of the medical device or an application for making changes in the documentation of the marketing authorization file for the medical device of potential risk of use class 2a (for sterile medical devices), 2b or 3, the documents shall be provided to the authorities as part of the marketing authorization file, able to confirm the proper conditions of manufacturing for the said manufacturer, and copies of certificates of compliance for the quality management system as per the related industry standard, namely GOST ISO 13485-2017 “Medical devices. Quality management systems. Requirements for regulatory purposes”, or related international standard ISO 13485 (if available), and copies of reports on previously performed inspections for standard compliance.

c) the manufacturers of medical devices who submitted applications for the marketing authorization of a medical device during the period of time from 1 January, 2023 through 31 December, 2023, shall confirm implementation of the quality management system by means of a primary inspection of production which has to be performed within 3 years of the date of the marketing authorization of the medical device concerned, following the procedure for non-scheduled inspection of production.

(para. 2 in the Decree No. 2517 of the Government of the Russian Federation dated 29/12/2022)

3. This Decree becomes effective from 01 September 2022 and is in force until 01 September 2028.

Chairman of the Government of the Russian Federation M. Mishustin

Approved by Decree of the Government of the Russian Federation No. 135 dated 09 February 2022

RULES FOR THE ORGANIZATION AND IMPLEMENTATION OF INSPECTION OF THE PRODUCTION OF MEDICAL DEVICES FOR COMPLIANCE WITH THE REQUIREMENTS FOR IMPLEMENTATION, MAINTENANCE AND EVALUATION OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES, DEPENDING ON THE POTENTIAL RISK OF THEIR USE 

List of amending documents

(As per Decree No. 2517 of the Government of the Russian Federation dated 29/12/2022)

I. General

1. These Rules determine the procedure for the organization and implementation of the inspection of the production of medical devices, which is to be performed by organizations reporting to the Federal Service for Surveillance in Healthcare (hereinafter the “Inspecting Organization”) in order to verify compliance with the requirements for the implementation, maintenance and evaluation of the quality management system for medical devices depending on the potential risk of their use, as per the applicable nomenclature of medical devices (hereinafter, accordingly, “Inspection of Production” and “Requirements”).

2. The following definitions are used in these Rules:

“Inspection of Production” means evaluation of the manufacturing conditions and evaluation of the QMS used by the manufacturer of the medical device in question.

“Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance found during inspection, or mitigation of any other unfavourable event.

“Critical Vendor” means the vendor whose services or products immediately affect the quality, efficiency and safety of the medical device in question.

“Preventive action” means action taken by the manufacturer in order to remove the root cause of potential non-compliance or a potential unfavourable event.

“Manufacturing Site” means the physically located 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.

“Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for the coordinated and efficient management of the organization which is the manufacturer of the medical devices, in terms of quality.

“Authority” means the Federal Service for Surveillance in Healthcare.

“Manufacturing conditions” means the infrastructure and process environment necessary to ensure the quality, efficiency and safety of the medical devices.

“Authorized Representative of the Manufacturer” means the legal entity or entrepreneur registered on the territory of the Russian Federation and authorized by the manufacturer of the medical device to represent their interests concerning the circulation of medical devices within the Russian Federation.

3. Inspection of Production has to be performed when:

there is production of medical devices subject to marketing authorization, and therefore requiring an expert review of quality, efficiency and safety, and also when such production had changed its legal address stated in the MAC of the said medical device, except for marketing authorization of the lot (batch) of medical devices and/or medical devices registered in accordance with Decree of the Government of the Russian Federation No 552 dated April 1, 2022 “On the approval of specific features of the circulation, including specific features pertaining to the marketing authorization, 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”.

(As per Decree No. 2517 of the Government of the Russian Federation dated 29/12/2022)

there is a production of medical devices manufactured to the individual orders of patients and which have specific requirements for their prescription by healthcare professionals.

4. The Inspecting Organization must keep a register of compliance statements (hereinafter the “Register of Statements”) which must be placed on the official website of the Authority in the information and communication Internet network (Hereinafter the “Internet network”) and must include the following information:

a) unique registration number of the related entry in the Register of Statements,

b) date and number of the related inspection report, and its validity period,

c) type of inspection, e.g. primary, repeated, non-scheduled (as needed),

d) purpose of the inspection (in the event it is an unscheduled one),

e) name of the medical device,

f) class of potential risk of the use of the manufactured medical products,

g) group or subgroup (if applicable) of the medical device depending on the risk class associated with its intended use, as per the list provided in Appendix No. 1,

h) name and location of the manufacturer of the medical device in question, or full name (with patronymic, if applicable) and residential address of the entrepreneur who is the manufacturer of this medical device,

i) addresses of the manufacturing sites,

j) results of the inspection.

5. The Authority shall keep, on its official website in the Internet network, a register of organizations involved in manufacturing medical devices to the individual orders of patients and those subject to special requirements for their prescription by healthcare professionals (hereinafter, “Register of Organizations”). The Register of Organizations shall include the following information:

a) unique registration number of the related entry in the Register of Organizations,

b) full and abbreviated (if applicable) name, including brand name, and legal form of the legal entity, or full name (with patronymic, if applicable) of the entrepreneur, type and ID number of their personal identification document, physical address of the legal entity or residential address of the entrepreneur, state registration number for the legal entity and tax payer identification number of the individual person,

c) addresses of the manufacturing sites,

d) name of the related medical devices, information on intended use as implant into the human body, intended use of the medical device made to individual patient order subject to specific requirements for their prescription by healthcare professionals.

The entry in the Register of Organizations shall be made on the basis of information received by the Authority concerning the entry made in the Register of Statements.

6. All information contained in the report made upon the Inspection of Production shall be mentioned in the following documents:

in the marketing authorization file of the medical device concerned, which is kept by the Authority,

in the Register of Organizations.

It is prohibited to manufacture medical devices to the individual orders of patients, and which are subject to special requirements for their prescription by healthcare professionals, specifically intended for implantation into the human body, if the manufacturer is not included in the Register of Organizations.

7. The procedure for the submission of information to be included in the Register of Organizations and the Register of Statements shall be determined by the Authority.

8. If the manufacturers of the medical devices with potential usage risk class 1 and/or with potential usage risk class 2a for non-sterile devices have already had their QMS evaluated (including design and development processes) as per those Rules, then during the validity period of the related Production Inspection Results Report, any changes to be made to the marketing authorization file of such medical devices shall be executed with notification only and do not require any expert review of the quality, efficiency and safety of such medical devices.

9. Information regarding the issue (or refusal to issue) of the Production Inspection Report shall be entered in the Register of Statements within 10 working days after such decision was made, and this information shall be published on the official website of the Authority in the Internet network.

10. Any expenses related to the Inspection of Production with the purpose of the evaluation of the QMS for medical devices shall be paid by the manufacturer of the medical device concerned on the basis of the contract made with the Inspecting Organization. The methodology for determining the service fee for the Inspection of Production of the medical devices for compliance shall be determined by the Ministry of Health of the Russian Federation.

When determining such service fee, the nominal duration of such inspection of production shall be established regardless of the actual time spent for the Inspection of Production.

11. The list of Inspecting Organizations is published on the official website of the Authority in the Internet network.

12. The Inspecting Organization shall have no specific interest in the results of the inspection of production.

The Inspecting Organization, its management and employees involved in the Inspection of Production, shall be not engaged in any kind of activity which may or potentially may affect the independent nature of their judgement or objectivity of the results of the Inspection of Production they perform, also they shall be neither developers, nor manufacturers nor vendors of any medical devices, as well as they shall not provide any maintenance or service for the medical devices involved, and they shall not be representative persons related to the developer, manufacturer or vendor of such medical devices, or entities involved in the maintenance or service (repairs) of the medical devices.

13. The Inspecting Organization shall document all related processes including:

a) processing the application for the Inspection of Production submitted by the manufacturer of the medical device concerned,

b) planning, execution and reporting of the Inspection of Production,

c) terms and conditions of the Contract for the Inspection of production made with the manufacturer of the medical device or with its authorized representative,

d) determining the manufacturing sites to be involved in the Inspection of Production,

e) completion of reports along with the conclusion of compliance or non-compliance of the quality management system for the medical device, as evaluated against specific requirements,

f) monitoring the implementation of corrective actions for non-compliance issues found during the Inspection of Production,

g) assignment of specific duties and authorities to various members of the inspection group during execution of the Inspection of Production (with regard to their related competencies), and involvement of third party experts, if necessary.

14. The Inspecting Organization shall document the procedure to ensure and keep confidential the nature of the information representing trade secrets, if such information shall be obtained during the inspection, considering the possibility to use third party experts and monitors assigned by the Authority.

The Confidentiality Agreement made between the Inspecting Organization and the manufacturer of the medical devices concerned shall contain terms which assume that the Inspecting Organization may provide certain materials to the Authority upon the inspection and based in its results.

15. The Inspecting Organization shall maintain all records related to the inspection and other related activities as readable and keep them stored for 10 years minimum; this requirement is applicable to all manufacturers of medical devices which have submitted applications for the Inspection of Production and/or passed such Inspection of Production. The records shall contain the following information and documentation:

a) information related to the application for the Inspection of Production and reports on the results of such Inspection,

b) contract for the Inspection of Production,

c) justification (calculation) of the expected duration of the Inspection;

d) information about follow-up and monitoring of Corrective Actions prescribed based on the Inspection results,

e) complaint records indicating subsequent Corrective Actions,

f) documentation to confirm competencies of the inspectors and third party experts,

g) the Confidentiality Agreement made between the Inspecting Organization and the manufacturer of the medical devices.

16. The Authority, acting as coordinator of the Inspecting organization's activities, has a right to send its own representatives (at its own expense) to participate as third party inspector in the Inspection concerned, regarding the evaluation of the QMS for medical devices. The manufacturer of the medical devices concerned shall provide unrestricted access for the inspectors and third party inspectors to the assets and processes subject to the said Inspection.

 

II. The Procedure of the Inspection of Production of

Medical Devicee 

17. Evaluation of the quality management system for medical devices may be performed as a primary, routine (scheduled) or non-scheduled Inspection of Production.

18. The primary inspection of production shall be performed as part of the State Marketing Authorization process, if this requires evaluation of the quality, efficiency and safety of the medical device concerned, or with the purpose of making an entry into the Register of Organizations containing information mentioned in paragraph 5 of the Rules.

19. In order to perform the primary Inspection of production, the manufacturer of the medical device concerned or authorized representative of the manufacturer (maker) of the medical device (hereinafter the “Applicant”), shall provide a related application to the Inspecting Organization stating the names of the medical devices concerned, their groups or subgroups as per Appendix No. 1 to these Rules, and a list of manufacturing sites to be inspected, with the following documents to be added as supporting in electronic form (the so-called electronic documentation package):

A document stating the actual number of personnel involved in processes related to the evaluated quality management system for medical devices,

A copy of the report of the latest audit of the QMS for medical devices (if applicable), performed by the related certification authority (if the QMS is already certified).

20. The Inspecting Organization shall review the submitted documents within 10 days after the date on which the Applicant submitted the application for the Inspection of Production. If the decision on performing the Inspection of Production is positive, the Inspecting Organization shall conclude a contract with the Applicant for such Inspection of Production.

In the event of a negative decision about the Inspection of Production, the Inspecting Organization shall issue a related notification to the Applicant stating the reasons for which they refuse to perform the requested primary Inspection of Production (such letter shall be sent by registered mail with proof of delivery, or sent as an electronic document with an enhanced digital signature).

The reason for a negative decision on the primary Inspection of production is the non-compliance of the application with the list of documents mentioned in paragraph 19 of these Rules.

21. The quality management system for the conformity of medical devices to the requirements shall be evaluated during this primary Inspection of Production.

22. In the course of this primary Inspection of Production, the Inspecting Organization makes an inspection of all manufacturing sites listed in the related application.

When medical devices manufactured at the same manufacturing site belong to different groups (or subgroups) as per Appendix 1, depending on the class of potential risk of use, the Inspection of Production can involve those several groups (subgroups) during the same inspection procedure, as per the manufacturing sites named by the manufacturer in the related application.

23. The regulatory duration of such Inspection of Production shall be established regardless of the actual time spent for the Inspection of Production in order to determine the related service fee.

24. The regulatory duration of the Inspection of Production is calculated in person-days based on an 8-hour working day. The regulatory duration of the Inspection of Production includes the time spent outside the inspected organization and the time spent on analysis of the documentation and inspection of production planning, as well as the time spent directly at the inspected organization and spent on the reports generated.

If the entities subject to the Inspection of Production are located in another city in relation to the Inspecting Organization, then the regulatory duration of the Inspection of Production is increased by 2 person-days for each entity under inspection.

25. As a basis for calculation of the regulatory duration of the Inspection of Production, the actual number of employees of the Inspecting Organization involved in the processes within the framework of the evaluated QMS shall be used. The personnel only partially involved in the inspection shall be taken into account by converting their number into the related number of full-time personnel.

The parameters necessary for calculating the regulatory duration of the Inspection of Production depending on the actual number of employees at the entity under inspection are given in Appendix No. 2.

26. Certain actions during the primary. routine (scheduled) and unscheduled inspection are to be performed within the following terms:

the Inspecting Organization to review the documents provided by the Applicant in order to have the Inspection performed shall be within 10 working days after the date on which the Applicant submitted the application;

the Inspecting Organization to submit the application to the Authority for the evaluation of the quality management system for the medical device, using remote communication shall be no later than in 3 working days after the date on which the Applicant submitted the application for the Inspection of Production;

The Authority to send notification to the Inspecting Organization regarding a positive or negative decision on evaluation of the QMS for the medical device using remote communication shall be within a maximum 3 working days after the date on which the Authority received the application form the Inspecting Organization regarding evaluation of the quality management system for the medical device, using remote communication;

concluding a Contract for the Inspection of Production (including negotiation of terms, drawing up the draft and signature of the document) shall be within a maximum 10 working days after the decision on performing the Inspection of Production was made;

notification to be sent in the event of a negative decision on performing such Inspection of Production shall be within a maximum 3 working days after taking such negative decision’

issuing travel documents and any other documents necessary to inspect one or several manufacturing sites, and travel to the inspection sites shall be within a maximum 25 working days after concluding the Contract for the related Inspection of Production;

staying at the manufacturing site (including the inspection performed using remote communication) shall be for a maximum 5 working days after arrival.

27. When calculating the regulatory duration of the Inspection of Production, the terms set forth in paragraphs 29, 35 and 38 of these Rules shall be taken into account.

28. The cumulative duration of the Inspection of Production shall not exceed 90 days after the date on which the Applicant submitted the Application for the Inspection of Production.

29. Based on the results of the primary Inspection of Production, the Inspecting Organization shall, within 10 working days:

prepare a report as per the template provided in Appendix No. 3 and submit it to the Applicant either by registered mail with confirmed delivery or in the form of electronic document with an enhanced digital signature.

shall publish information mentioned in paragraph 4 of these Rules in the Register of Statements.

The validity period for the report on the findings of the primary Inspection of Production is 5 years after the date of its issue.

30. The results of the Inspection of Production are applicable to the group (subgroup) of medical devices listed in Appendix 1. For medical devices of potential risk of use class 1 and 2a, the results of the Inspection of Production are applicable to groups of medical devices. For medical devices of potential risk of use class 2b and 3, the results of the Inspection of Production are applicable to subgroups of medical devices.

31. The routine (scheduled) Inspection of Production shall be conducted once every 5 years after the issue of the Report of the results of the Inspection of Production.

In order to perform the routine (scheduled) Inspection of Production, the manufacturer of the medical device shall provide the Application to the Inspecting Organization for the performance of the routine (scheduled) Inspection of Production, stating the names of the medical devices concerned, their groups or subgroups as per Appendix No. 1 to these Rules, and a list of manufacturing sites to be inspected, with the following documents to be added as supporting in electronic form (the so-called electronic documentation package):

document stating the actual number of personnel involved in processes related to the evaluated quality management system for medical devices,

copy of the report on results of the latest Inspection of Production,

copy of the report of the latest audit of the QMS for medical devices (if applicable), performed by the related certification authority (if the QMS is already certified).

32. The Inspecting Organization shall review the submitted documents within 10 days after the date on which the Applicant submitted the application for the routine (scheduled) Inspection of Production. If the Inspecting Organization decided positively on such routine (scheduled) Inspection of Production, it shall conclude a related Contract with the Applicant.

In the event of a negative decision about the Inspection of Production, the Inspecting Organization shall issue a related notification to the Applicant stating the reasons for which they refuse to perform the requested primary Inspection of Production; such letter shall be sent as an electronic document with an enhanced digital signature.

The reason for a negative decision on a routine (scheduled) Inspection of Production is non-compliance with the list of documents mentioned in paragraph 31 of these Rules.

33. During the routine (scheduled) Inspection of Production, inspectors shall evaluate the maintenance of regulative compliance of the QMS for the medical devices in question.

34. The routine (scheduled) Inspection of Production shall be conducted at the manufacturing sites selected by the Inspecting Organization on the basis of medical devices selected for each group or subgroup of the manufactured medical devices (depending of the class of potential risk of use), as per Appendix No. 1 to the Rules, and on the basis of the review of documentation and records, which are the result of the implementation of related documented processes and/or operational procedures of the QMS for medical devices, as applicable to the selected medical devices. For medical devices of potential risk of use class 1 and 2a, the representative sample of medical devices has to be selected by the Inspecting Organization on the basis of a group of related medical devices, while for classes 2b and 3 the selection basis shall be a related subgroup of medical devices.

Criteria which the Inspecting Organization uses for the selection of representative samples of the medical devices concerned are the novelty of engineering solutions, their intended use and production technologies, with regard to the findings of previous Inspections of Production. A justification of the selection of a representative sample of medical devices shall be included in the final report on the results of the Inspection of Production.

35. Based on the results of the routine (scheduled) Inspection of Production, the Inspecting Organization shall, within 10 working days:

prepare a report as per the template provided in Appendix No. 4 and issue (submit) it to the Applicant either by registered mail with confirmed delivery or in the form of an electronic document with an enhanced digital signature.

shall publish information mentioned in paragraph 4 of these Rules in the Register of Statements.

The validity period for the report on the findings of the routine (scheduled) Inspection of Production is 5 years after the date of its issue.

36. A non-scheduled Inspection of Production shall be carried out when:

a) it is necessary to make changes to the list of manufacturing sites and list of groups (subgroups) of medical devices on the basis of the final report on the results of the Inspection,

b) there is a need to confirm implementation of corrective actions on the basis of the Inspection of Production;

c) it is necessary to confirm the elimination of the root causes which resulted in the compromised quality of the medical devices concerned;

d) it is necessary to confirm that the manufacturer has implemented the quality management system for medical devices (in the event when the compliance of such QMS was not evaluated yet).

37. In order to perform the non-scheduled Inspection of Production, the manufacturer of the medical device shall provide the Application to the Inspecting Organization to carry out a non-scheduled Inspection of Production, stating the names of the medical devices concerned, their groups or subgroups as per Appendix No. 1 to these Rules, and a list of manufacturing sites to be inspected, with the following documents to be added as supporting in electronic form (the so-called electronic documentation package):

document stating the actual number of personnel involved in processes related to the evaluated quality management system for medical devices,

information about the root causes resulting in the production and release of medical devices of compromised quality (as applicable).

In the event when the non-scheduled Inspection of Production is performed as per sub-paragraph (a) of paragraph 36 of the Rules, the Application for such Inspection shall be submitted to the Inspecting Organization before submission of the document package for the marketing authorization of the related medical devices.

38. Based on the results of the unscheduled Inspection of Production, the Inspecting Organization shall, within 10 working days:

prepare a report as per the template provided in Appendix No. 5, except for an inspection performed as per subparagraph (d) of paragraph 36 of the Rules, and issue (submit) it to the Applicant either by registered mail with confirmed delivery or in the form of an electronic document with an enhanced digital signature.

for the purposes mentioned in subparagraph (d) of paragraph 36 of the Rules, complete the report as per the template provided in Appendix No. 3 to these Rules,

shall publish information mentioned in paragraph 4 of these Rules in the Register of Statements.

39. The Inspecting Organization in charge of the Inspection of Production shall not come to a positive conclusion on the inspection if the quality management system for the medical devices appears to be non-compliant, or it is not actualized at the time of the inspection.

All non-compliances revealed during the Inspection of Production shall be rectified by the manufacturer of the medical device during the inspection, or within 30 days after completion of the Inspection of Production. Should the non-compliances be rectified during the inspection, such findings shall be reported but not taken into account in the integral score of non-compliance importance for the evaluated QMS.

 

III. Integral score of the importance of the non-compliances revealed for the quality management system for medical devices during the Inspection of Production 

40. Classification of non-compliances found during the Inspection of Production for regulative compliance (hereinafter “non-compliances”) involves two steps:

Step I involves the application of a qualification matrix for the purpose of preliminary evaluation of the significance of the non-compliances.

Step II involves the application of boosting scores in order to get the final evaluation of the significance of the non-compliances.

In the event of multiple non-compliance issues pertaining to the same regulatory requirement, they shall all be considered as one non-compliance for the purposes of the scoring.

41. In the qualification matrix, all findings (non-compliances) are divided into 4 groups characterized quantitatively by the significance of the related non-compliance in terms of the safety, efficiency and quality of the related medical devices, namely:

a first time identified issue directly affecting the safety, efficiency and quality of the medical device has a score of 3 points,

a first time identified issue with an indirect effect on the safety, efficiency and quality of the medical device has a score of 1 point,

a repeatedly identified issue directly affecting the safety, efficiency and quality of the medical device has a score of 4 points,

a repeatedly identified issue with an indirect effect on the safety, efficiency and quality of the medical device has a score of 2 points.

42. The qualification matrix reflects therefore both the effect of a specific non-compliance on the safety, efficiency and quality of the medical device and the repetition of such non-compliance.

43. Non-compliance is considered as having an indirect effect on the safety, efficiency and quality of the medical device, when it is related to requirements concerning the functional operations of the QMS for medical devices, and it is qualified as having a direct effect when the related requirements concern design and development, manufacturing and release control of the related medical device.

“First time identified” means that such non-compliance was not identified during 2 previous Inspections of Production, in which the same processes within the QMS were evaluated at the manufacturing site.

“Repeatedly identified” means that such non-compliance was identified during one of 2 previous Inspections of Production, in which the same processes within the QMS were evaluated at the manufacturing site.

44. The quantitative evaluation result (score) calculated for any particular non-compliance at step I shall be adjusted and refined at step II by means of so-called boosting scores, which shall be applied as follows:

when there is a lack of documented processes related to design and development and in-process control, provided such documented processes are necessary to ensure the safety and efficiency of the medical device;

when a compromised medical device was released on the market. If the non-scheduled Inspection of Production is ordered by the manufacturer of the medical device in order to confirm that the root causes of such release of a compromised product have been eliminated, then the related boosting score shall not be applied.

Each non-compliance identified at the Step I shall have 1 boosting score added normally.

45. The Inspecting Organization shall not come to a positive conclusion on the regulatory compliance of the manufacturer of the medical devices if at least one (or more) non-compliances have a score of 5 or 6 points, or when more than 2 non-compliances have a score of 4 points.

46. The results of this integral evaluation of the significance of the non-compliances must be documented as a report as per the template provided in Appendix No. 6.

47. When the Inspecting Organization reveals non-compliances, for which the integral evaluation score of significance will be so high that the decision on the compliance of the related quality management system will be negative, in this case the Inspecting Organization has to inform the Applicant that additional actions shall be taken or additional materials shall be provided in order to confirm the positive result of the implemented corrective actions.

48. If the Applicant disagrees with the negative overall conclusion or with the findings of the inspection, it may submit the claim to the Inspecting Organization within 30 working days after receiving the copy of the Inspection of Production results by the Inspecting Organization. The Inspecting Organization must review the claim and respond within 15 working days after receiving it. If no mutual agreement has been achieved, the Applicant has the right to apply to a local court within the jurisdiction to which the Inspecting Organization belongs, or it may apply to the Authority. If the Applicant does not agree with the decision made by the Authority, it may apply to the local court at the jurisdiction to which the Authority belongs.

49. If the manufacturer of the medical device concerned fails to rectify the non-compliances, or fails to do so within the proper terms mentioned in paragraph 39 of the Rules, the Inspecting Organization within 5 working days shall enter the appropriate record in the Register of Statements.

The Authority has a legal right to pause usage of the medical device on the territory of the Russian Federation until the manufacturer rectifies all non-compliances mentioned in the Inspection of Production final report, or do the same upon the expiry of the current report.

 

IV. Procedure for the Inspection of Production using remote communication media (video communication)

50. Upon the decision of the Authority, evaluation of the quality management system for medical devices may be performed using means of remote communication (such as video communication), under the following circumstances:

a) when there is a threat of an emergency or emergency situation or already occurring, and there are measures taken for its mitigation, or in the event of a threat of a dangerous epidemic condition, or in the event of a threat of spreading diseases or injuries due to the adverse effect of chemical, biological or radiation factors;

b) in the event of force majeur conditions or other conditions beyond the control of the parties involved, which can pose a threat to the life and/or well-being of inspectors.

51. Before the evaluation of the QMS for medical devices can be performed using remote communication means, the manufacturer shall confirm geolocation data (longitude and latitude) of the related manufacturing site.

52. In order to have an evaluation of the QMS for the medical device performed using means of remote communication, the manufacturer must provide documentation and information as per Appendix No. 7.

In the event of a non-scheduled Inspection of Production of medical devices, the documents and information shall be provided to justify such inspection.

Appendix No. 1 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

LIST OF GROUPS AND SUBGROUPS OF MEDICAL DEVICES

Group of medical devices (for potential risk classes 1 and 2a)	Subgroup of medical devices (for potential risk classes 2b and 3)
1. Non-active medical devices (except those for IVD)	1.1. Non-active cardiac implants
	1.2. Non-active orthopaedic implants
	1.3. Non-active implants of soft tissues
	1.4. Non-active functional implants
	1.5. Non-active dental implants and materials for dentistry
	1.6. Non-active medical devices used for injections, infusions, blood transfer and dialysis
	1.7. Non-active ophthalmologic medical devices
	1.8. Non-active orthopaedic medical devices and medical devices used for physical rehabilitation
	1.9. Medical devices used for contraception
	1.10. Medical tools
	1.11. Non-active medical devices for disinfection, hygienic processing and sterilization of other medical devices
	1.12. Sutures, medical dressings and other non-active medical devices for wound management.
	1.13. Non-active medical devices not otherwise included into subgroups 1.1–1.12
2. Active non-implantable medical devices (except those for IVD)	2.1. Medical devices used for monitoring of physiological parameters
	2.2. Medical devices for visualization using ionizing radiation
	2.3. Medical devices for visualization not using ionizing radiation
	2.4. Medical devices for radiation therapy using ionizing radiation
	2.5. Medical devices for radiation therapy not using ionizing radiation
	2.6. Medical devices used for lithotripsy
	2.7. Active medical devices for extracorporal blood circulation, intravenous infusion and plasmapheresis
	2.8. Active medical devices for inhalation anaesthesia, hyperbaric medical devices and medical devices for respiratory therapy
	2.9. Active medical devices for stimulation and inhibition
	2.10. Active surgical medical devices
	2.11. Active ophthalmologic medical devices
	2.12. Active medical devices for dentistry
	2.13. Active medical devices for disinfection and sterilization of other medical devices
	2.14. Active medical devices for rehabilitation, and active prosthetics
	2.15. Active medical devices for positioning and transportation of patients
	2.16. Standalone medical software
	2.17. Active medical devices for in vitro fertilization and assisted fertilization
	2.18. Active medical devices not otherwise included into subgroups 2.1–2.17
3. Active implantable medical devices	3.1. Active implantable medical devices for stimulation and inhibition
	3.2. Active implantable medical devices for delivery of drugs and other substances
	3.3. Active implantable medical devices used to support, substitute or otherwise replace certain functions of the bodily organs
	3.4. Radioactive implants for intra-tissue radiotherapy
	3.5. Active medical devices not otherwise included into subgroups 3.1–3.4
4. Medical devices for in vitro diagnostics	4.1. Reagents, reagent sets, calibrators and controls
	4.2. Devices and equipment for in vitro diagnostics
	4.3. Standalone medical software for in vitro diagnostics
	4.4. Other medical devices for in vitro diagnostics, not otherwise included into subgroups 4.1–4.3

Appendix No. 2 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

 

INDICES FOR CALCULATION OF THE REGULATORY DURATION OF THE INSPECTION OF PRODUCTION DEPENDING ON THE ACTUAL NUMBER OF EMPLOYEES AT THE INSPECTION FACILITY

Actual number of employees (persons)	Regulatory duration of the primary Inspection of Production (person-days)	Regulatory duration of the routine (scheduled) Inspection of Production (person-days)
5–49	6	4
50–99	7	5
100–199	8	6
200–499	9	7
500–999	10	8
1,000–1,999	11	9
2,000–4,999	12	10
More than 5,000	13	11

 

Appendix No. 3 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance

with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

 

 

REPORT on the results of the primary Inspection of Production

1.	Report number
2.	The organization performing the Inspection of Production (full name and abbreviation, if applicable) of the legal entity (including also the brand name), legal form and address (location)
3.	Information about the manufacturer of the medical device:
3.1.	Full name and abbreviation, if applicable, of the legal entity (including also the brand name), legal form and address (location), contact details
3.2.	Organizational structure and interactions with legal entities within the framework of the QMS for medical devices
3.3.	List of manufacturing sites (including the addresses) and medical devices produced correspondingly (stating the approximate number of employees involved in processes covered by the evaluated QMS, as well as contact details).
3.4.	List of medical devices manufactured for circulation on the territory of the Russian Federation
3.5.	List of groups (subgroups) of medical devices involved in the Inspection of Production, as per the manufacturer`s Application (also indicate whether design and development processes are included in the scope of the Inspection of Production).
3.6.	List of critical vendors (stating their addresses, list of medical devices supplied or services rendered, and contact details)
4.	Information regarding the Inspection of Production:
4.1.	Dates of the Inspection of Production, including dates of field inspections for each facility inspected
4.2.	List of inspection team members (indicating the roles of team members and information about interpreters and monitors, if present)
4.3.	Plan of the Inspection of Production
5.	Results of the Inspection of Production (for each facility inspected)
5.1.	General description of the activities inspected and/or production processes
5.2.	Full names (with patronymic, if applicable) and titles of the surveyed employees
5.3.	Names of medical devices selected for examination as representative samples, and justification of such selection
5.4.	Types and quantity of documents and records reviewed
5.5.	List of issues in which the quality management system for medical devices was non-compliant with the requirements for the implementation, management and evaluation of the QMS for medical devices depending on the potential risk of their use
5.6.	Information regarding non-compliances rectified during the Inspection of Production, and terms for the implementation of corrective actions towards remaining non-compliances, and how such actions shall be confirmed (via supporting documentation or by means of a field inspection)
6.	Conclusions:
6.1.	The conclusion on compliance (or non-compliance) of the quality management system for medical devices with the related implementation requirements (also stating the information as to whether design and development programs for the inspected groups (subgroups) of medical devices were included into the scope of inspection)
7.	Full names (with patronymic, if applicable) and titles of the inspectors
8.	Signature, stamp (if applicable)

Note.

The following definitions are used in this Appendix “Inspection of Production” means evaluation of the manufacturing conditions and evaluation of the QMS used by the manufacturer of the medical device in question. “Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance found during inspection, or mitigation of any other unfavourable event. “Critical Vendor” means the vendor whose services or products immediately affect the quality, efficiency and safety of the medical device in question. “Manufacturing Site” means the physically located 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. “Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for coordinated and efficient management of the organization which is the manufacturer of the medical devices, in terms of quality.

 

Appendix No. 4 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

REPORT on the results of the routine (scheduled) Inspection of Production

1.	Report number
2.	The organization performing the Inspection of Production (full name and abbreviation, if applicable) of the legal entity (including also the brand name), legal form and address (location)
3.	Information about the manufacturer of the medical device:
3.1.	Full name and abbreviation, if applicable, of the legal entity (including also the brand name), legal form and address (location), contact details
3.2.	Organizational structure and interactions with legal entities within the framework of the QMS for medical devices
3.3.	List of manufacturing sites (including the addresses) and medical devices produced correspondingly (stating the approximate number of employees involved in processes covered by the evaluated QMS, as well as contact details).
3.4.	List of medical devices released for circulation on the territory of the Russian Federation
3.5.	List of groups (subgroups) of medical devices according to the previously issued compliance statement (also indicate as to whether design and development processes are included in the scope of the Inspection of Production).
3.6.	List of critical vendors (stating their addresses, list of devices supplied or services rendered, and contact details)
4.	Information regarding the Inspection of Production:
4.1.	Dates of the Inspection of Production, including dates of field inspections for each facility inspected
4.2.	List of inspection team members (indicating the roles of team members and information about interpreters and inspectors (experts), if present)
4.3.	Plan of the Inspection of Production
5.	Results of the Inspection of Production (for each facility inspected)
5.1.	General description of the activities inspected and/or production processes
5.2.	Full names (with patronymic, if applicable) and titles of the surveyed employees
5.3.	Names of medical devices selected for examination as representative samples, and justification of such selection
5.4.	Types and quantity of documents and records reviewed
5.5.	List of issues in which the quality management system for medical devices was non-compliant with the requirements for the implementation, management and evaluation of the QMS for medical devices depending on the potential risk of their use
5.6.	Information regarding non-compliances rectified during the Inspection of Production, and terms for the implementation of corrective actions towards remaining non-compliances, and how such actions shall be confirmed (via supporting documentation or by means of a field inspection)
6.	Conclusions:
6.1.	Conclusion on compliance (or non-compliance) of the quality management system for medical devices with the related actualization requirements
7.	Full names (with patronymic, if applicable) and titles of the inspectors
8.	Signature, stamp (if applicable)

Note.

The following definitions are used in this Appendix “Inspection of Production” means evaluation of the manufacturing conditions and evaluation of the QMS used by the manufacturer of the medical device in question. “Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance found during inspection, or mitigation of any other unfavourable event. “Critical Vendor” means the vendor whose services or products immediately affect the quality, efficiency and safety of the medical device in question. “Manufacturing Site” means the physically located 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. “Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for coordinated and efficient management of the organization which is the manufacturer of the medical devices, in terms of quality.

Appendix No. 5 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

 

REPORT on the results of the non-scheduled Inspection of Production

 

1.	Report number
2.	The organization performing the Inspection of Production (full name and abbreviation, if applicable) of the legal entity (including also the brand name), legal form and address (location)
3.	Information about the manufacturer of the medical device:
3.1.	Full name and abbreviation, if applicable, of the legal entity (including also the brand name), legal form and address (location), contact details
3.2.	Organizational structure and interactions with legal entities within the framework of the QMS for medical devices
3.3.	List of manufacturing sites (including the addresses) and medical devices produced correspondingly (stating the approximate number of employees involved in processes covered by the evaluated QMS, as well as contact details).
3.4.	List of medical devices released for circulation on the territory of the Russian Federation
3.5.	List of groups (subgroups) of medical devices according to the previously issued compliance statement (also indicate as to whether design and development processes are included in the scope of the Inspection of Production).
3.6.	List of critical vendors (stating their addresses, list of medical devices supplied or services rendered, and contact details)
4.	Information regarding the Inspection of Production:
4.1.	Dates of the Inspection of Production, including dates of field inspections for each facility inspected
4.2.	List of inspection team members (indicating the roles of team members and information about interpreters and monitors, if present)
4.3.	Goals and objectives of the Inspection of Production
4.4.	Scope and content of the Inspection of Production
5.	Results of the Inspection of Production for each facility inspected:
5.1.	General description of the activities inspected and/or production processes
5.2.	Full names (with patronymic, if applicable) and titles of the surveyed employees
5.3.	Names of medical devices selected for examination as representative samples, and justification of such selection with regards to the goal of the inspection
5.4.	Types and quantity of documents and records reviewed
5.5.	List of issues and discrepancies in which the quality management system for medical devices was non-compliant with the requirements for implementation, management and evaluation of the QMS for medical devices depending on the potential risk of their use
5.6.	Information regarding discrepancies rectified during the inspection of production, and terms for the implementation of corrective actions towards remaining discrepancies, and how such actions shall be confirmed (with regard to the goal of the inspection)
6.	Conclusions:
6.1.	Conclusion on compliance (or non-compliance) of the quality management system for medical devices with the related implementation and actualization requirements (and with regard to the goal of the inspection)
7.	Full names (with patronymic, if applicable) and titles of the inspectors
8.	Signature, stamp (if applicable)

Note.

The following definitions are used in this Appendix “Inspection of Production” means evaluation of the manufacturing conditions and evaluation of the QMS used by the manufacturer of the medical device in question. “Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance found during inspection, or mitigation of any other unfavourable event. “Critical Vendor” means the vendor whose services or products immediately affect the quality, efficiency and safety of the medical device in question. “Manufacturing Site” means the physically located 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. “Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for coordinated and efficient management of the organization which is the manufacturer of the medical devices, in terms of quality.

 

Appendix No. 6 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

REPORT On the Integral Score of the Importance of the Non-Compliance Issue Determined for the Quality Management System with the Requirements for the Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices, Depending On the Potential Risk of Their Use

Item No.	Non-compliance	Non-compliance severity
		I step, score	II Step, no documented processes, score	II step, release of compromised medical device, score	cumulative score for non-compliance
1.
2.

Total score

 

Appendix No. 7 to the Rules for the Organization and Performance of the Inspection of Production of Medical Devices for Compliance with the Requirements Concerning Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use

LIST OF THE DOCUMENTS AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER OF MEDICAL DEVICES FOR EVALUATION OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES PERFORMED USING MEANS OF REMOTECOMMUNICATION

Requirements (justification)	For the primary inspection	For the routine (scheduled) inspection
Description of the quality management system for medical devices depending on the potential risk of their use in compliance with the requirements for implementation, maintenance and evaluation of the quality management system for medical devices depending on the potential risk of their use	full description of the quality management system for medical devices	short information regarding changes implemented since the last inspection
List of employees involved in processes related to the evaluated quality management system for medical devices	document stating the actual number of personnel involved in processes related to the evaluated quality management system for medical devices,	document stating the actual number of personnel involved in processes related to the evaluated quality management system for medical devices,
List of medical devices manufactured (or planned for manufacture) at the manufacturing site involved	names of the medical devices	names of the medical devices
Availability of technical documentation for the medical devices	technical devices in searchable electronic format	technical devices in searchable electronic format
Availability of the report on the results of the latest audit conducted by the certification authority for the quality management system for medical devices, and the report on the results of the latest Inspection of Production (with notarized translation, if applicable), certificate of compliance with GOST ISO 13485 standard or related international standard ISO 13485 (if available)	copy of the report on the results of the latest audit conducted by the certification authority for the quality management system for medical devices, and the report on the results of the latest Inspection of Production (with notarized translation, if applicable), certificate of compliance with GOST ISO 13485 standard or another standard corresponding to international standard ISO 13485 (if available)	copy of the report on the results of the latest audit conducted by the certification authority for the quality management system for medical devices, and the report on the results of the latest Inspection of Production (with notarized translation, if applicable), certificate of compliance with GOST ISO 13485 standard or another standard corresponding to international standard ISO 13485 (if available)
Processes for the design and development of the quality management system for medical devices (potential risk of use class 3)	documents and information related to medical devices for which the Inspection of Production is performed: a) procedures for design and development (including risk management); b) documentation describing the design procedure covering the whole product range for the medical device in question’ c) design records for the medical device in question confirming that design and development procedures are established and implemented; d) process input data are developed in proper consideration of the intended use of the medical device; e) specifications for the medical device in question in order to confirm that output data of the medical device project, which ensure safety and efficiency of use of the medical device, are determined; f) documents confirming that risk management actions were determined and implemented, risk acceptability criteria are established and are corresponding to the situation, any residual risk is evaluated and. if necessary, reported to the end user as per legal requirements;	documentation and records related to medical devices selected as representative samples
Processes of documentation and records management for the quality management system for medical devices (in the event when for the QMS concerned there is no proof of conformity to the requirements of GOST ISO 13485 standard or related international standard ISO 13485)	documents and information related to medical devices for which the Inspection of Production is performed: a) procedures for the identification, storage and removal (destruction) of documents and records (including management of change) are developed; b) documents necessary for the organization to be able to plan production processes, implement and manage them; c) evidence of the conformity of the medical devices concerned with the requirements (including the requirements of applicable standards), description of the medical devices, including instructions for use (operation manuals), materials and specification; d) consolidated documentation for verification and validation of projects (including, data of clinical trials (tests); e) labelling of the medical devices; f) risk management documentation	documentation and records related to medical devices selected as representative samples
Production processes and release control of the medical devices	documents and information related to medical devices for which the Inspection of Production is performed: a) documentation of production processes for batch products (including manufacturing conditions); b) documents related to the sterilization process (for medical devices which are released as sterile units). including: proof of proper documentation of sterilization, and proper management of parameter records for each sterilized batch of medical devices; proof of validation of the sterilization process; proof of adherence to established parameters of the sterilization process; c) documents confirming that production processes are manageable and monitored, and that they are functioning within the established range of parameters, and proof of the necessary level of production and/or service control provided by the critical vendors; d) documentation confirming the identification and traceability of the medical devices and their production processes, as well as their compliance with the established requirements; e) documentation confirming that activities related to the release control of the medical devices ensure their compliance with the established requirements and this is documented	documentation and records related to medical devices selected as representative samples
Processes for corrective and preventive actions for the quality management system for medical devices (in the event when for the QMS concerned there is no proof of conformity to the requirements of GOST ISO 13485 standard or related international standard ISO 13485)	documents and information related to medical devices for which the Inspection of Production is performed: a) documentation confirming that procedures for corrective and preventive actions are developed; b) documentation confirming that existing means of control are sufficient to prevent dissemination of medical devices for which the quality is not compliant with the requirements set for the expert review of the quality, safety and efficiency of the medical devices; c) document conforming that preventive and corrective actions are effective; d) documents confirming that the manufacturer of the medical device has developed an efficient procedure for issuing and using the safety notification for the medical device	documentation and records related to medical devices selected as representative samples
Evaluation of processes related to the consumer (if there is no evidence of the compliance of the quality management system for the medical devices with the requirements of the GOST ISO 13485 standard or related international standard ISO 13485, otherwise the evaluation has to be performed regarding after-sales monitoring)	documents and information related to medical devices for which the Inspection of Production is performed: a) documentation confirming that measures were taken by the manufacturer, necessary to establish connection with the consumers in order to exercise the necessary corrective and preventive actions, that the manufacturer has established and keeps actualized a system for the collection and review of data related to the safety and efficiency of the medical devices in the after-sales period, and that the manufacturer reports to the authorized body regarding the results of the after-sales monitoring of the safety and efficiency of the medical devices; b) documents confirming that consumer feedback is analyzed by the manufacturer of the medical device during the life cycle of the product, and that the data obtained are used for repeated risk analyses and, if necessary, for the actualization of risk management activities	documentation and records related to medical devices selected as representative samples

Note.

The following definitions are used in this Appendix “Inspection of Production” means evaluation of the manufacturing conditions and evaluation of the QMS used by the manufacturer of the medical device in question. “Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance found during inspection, or mitigation of any other unfavourable event. “Critical Vendor” means the vendor whose services or products immediately affect the quality, efficiency and safety of the medical device in question. “Preventive action” means action taken by the manufacturer in order to remove the root cause of potential non-compliance or a potential unfavourable event. “Manufacturing Site” means the physically located 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. “Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for the coordinated and efficient management of the organization which is the manufacturer of the medical devices, in terms of quality. “Authority” means the Federal Service for Surveillance in Healthcare. “Manufacturing conditions” means the infrastructure and process environment necessary to ensure the quality, efficiency and safety of the medical devices.