
Order No. 136 by the Ministry of Health of the Russian Federation
Decree of the Government of the Russian Federation No. 136 dated 09 February 2022 “On approval of the requirements for the implementation, management and evaluation of the QMS for medical devices depending on the potential risk of their use”
GOVERNMENT OF THE RUSSIAN FEDERATION
DECREE No. 136 dated 09 February 2022
ON THE APPROVAL OF THE REQUIREMENTS FOR THE IMPLEMENTATION, MAINTENANCE AND EVALUATION OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK OF THEIR USE
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 requirements for the implementation, management and evaluation of the QMS for medical devices depending on the potential risk of their use.
2. To establish that the implementation and maintenance of the quality management system as part of the production of medical devices in accordance with the international treaties and regulations comprising the Law of the Eurasian Economic Union are to be considered as confirmation of compliance of the production of the medical device with the requirements set forth in this Decree.
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. 136 dated 09 February 2022
REQUIREMENTS FOR THE IMPLEMENTATION, MAINTENANCE AND EVALUATION OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK OF THEIR USE
1. The manufacture of medical devices subject to marketing authorization, which are made to an individual patient`s order with specific requirements for their prescription by healthcare professionals, shall comply 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 in accordance with the nomenclature of medical devices as approved in accordance with part 2 of Article 38 of the Federal Law “On the Basic Principles of Healthcare in the Russian Federation”.
2. For the purposes of these Requirements, the following terms are used:
“Corrective Action” means action to be taken by the medical devices’ manufacturer in order to remove the root cause of non-compliance with the manufacturing conditions found during inspection or mitigation of any other unfavorable event.
“Preventive action” means action taken by the manufacturer in order to remove the root cause of potential non-compliance or a potential unfavourable event.
“Quality Management System for Medical Devices” means an organizational structure, functions, procedures, processes and resources necessary for the coordinated and efficient management by the manufacturer of the medical devices, in terms of quality.
“Manufacturing conditions” means the infrastructure and process environment necessary to ensure the quality, efficiency and safety of the medical devices.
3. Manufacturers of medical devices (except the manufacturers of medical devices with the potential risk of usage class 1 and non-sterile medical devices with the potential risk of usage class 2a) shall implement the quality management system for medical devices depending on the class of potential risk of their use.
4. Manufacturers of medical devices with the potential risk of usage class 1 and non-sterile medical devices with the potential risk of usage class 2a have the right to implement and maintain the quality management system for medical devices depending on the class of potential risk of their use.
5. Manufacturers of medical devices with the potential risk of usage class 2a (for sterile medical devices) 2b shall implement the quality management system for medical devices (except for design and development processes).
6. Manufacturers of medical devices with the potential risk of usage class 3 shall implement the quality management system for medical devices, including design and development processes.
7. Manufacturers of the medical devices made to the individual orders of patients subject to specific requirements for their prescription by healthcare professionals, and which are intended for implantation into the human body shall, within one year after the date on which these requirements come into full force, implement the quality management system for medical devices covering the design and development processes for medical devices.
8. In order to implement the quality management system for medical devices, the manufacturer of medical devices shall:
a) develop documented requirements for risk management for all steps of the life cycle of the said medical device;
b) determine the processes necessary for the efficient functioning of the quality management system for the medical devices (hereinafter the “processes”) and use of such processes at the manufacturer`s plant;
c) determine the sequence of the processes and their inter-relations;
d) determine the criteria and methods necessary to ensure efficiency, both during implementation of the processes and in their management;
e) ensure that all manufacturing conditions are met, and all the resources and information necessary for supporting the processes and performance of their monitoring are present;
f) perform the monitoring, measurements (where applicable) and analysis of the processes;
g) take actions necessary to achieve the planned results and maintain efficiency of the processes.
9. In order to properly maintain the QMS for the medical devices, all its elements (organizational structure, methodology and description of the processes) shall be properly documented and actualized.
The documentation of the QMS for medical devices shall be drawn up on paper and/or on electronic media.
If the documents mentioned above are written in a foreign language, they shall be presented with a duly certified Russian translation.
10. Documentation of the QMS for the medical devices shall contain:
a) a description of the specifications for the medical device, standards or specific sections (paragraphs/subparagraphs) which will apply, and if the related standards are not applicable, then a description of methods to be used to ensure that the medical devices so released will be safe, efficient and of good quality.
b) a description of the methods of control used by a third party, and the depth of control in the event that development and (or) release control will be the responsibility of a third party;
c) a description of the production processes, quality control and assurance processes for the medical device concerned, as well as a description of the processes and systematic means to be used for the quality control and assurance of the medical device, including the processes related to corrective and preventive actions;
d) a description of the documentation used for the recording of quality indices pertaining to the medical device (e. g. reports on internal audits, test reports, etc.);
e) a description of the control means used to ensure the necessary quality of the medical device and the efficient functioning of the QMS for the medical device;
f) a description of the plans, procedures and feedback documentation used for establishing a connection with the consumers (including but not limited to the needs of monitoring the safety and efficiency of the medical device at the after-sales stage).
11. Processes for the design and development of the quality management system for medical devices include the following:
a) availability of 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) documents and records (based on selected design records for the medical device in question) confirming that design and development procedures have been established and implemented;
d) documents and records confirming that the process input data have been 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 the output data of the medical device project, which ensure the safety and efficiency of using the medical device, have been properly determined;
f) documents and records confirming that risk management actions have been determined and implemented, risk acceptability criteria are established and appropriate, any residual risk is evaluated and, if necessary, reported to the end user;
12. Processes for the documentation and records management system for the medical devices include the following:
a) documents and records confirming that procedures for identification, storage and removal (destruction) of documents and records (including management of change) have been properly developed;
b) confirmation of the existence of documents necessary for the organization to be able to plan production processes, implement and manage them;
c) confirmation of the fact that the documentation for the medical device contains the following items:
certificates of conformity for the medical devices confirming that they are compliant with the requirements of local regulations (particularly with the requirements of the applicable standards)
description of the medical devices. including instructions for use, materials and specifications;
consolidated documentation on the verification and validation of the projects;
labelling of the medical devices;
risk management documentation.
13. Production processes and release control of medical devices shall include:
a) production processes (including manufacturing conditions);
b) sterilization processes (for medical devices which are released as sterile units). including:
determination of proper documentation of sterilization, and proper management of parameter records for each sterilized batch of the medical devices;
determination of validation of the sterilization process;
determination of adherence to the established parameters of the sterilization process;
c) documents confirming that production processes are manageable and monitored, and that they function within the established range of parameters, and confirmation of the necessary level of production and/or service control provided by the critical vendors;
d) documentation confirming 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.
14. Processes for corrective and preventive actions for the quality management system for the medical devices include the following:
a) documentation confirming that procedures for corrective and preventive actions have been developed;
b) documentation confirming that the control means prevent the dissemination of compromised medical devices;
c) documentation confirming that preventive and corrective actions are efficient.
15. Processes related to the consumer include the following:
a) documentation confirming that the manufacturer of the medical device has taken all necessary actions to establish a proper connection with consumers in order to perform the necessary corrective and preventive actions;
b) documentation 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.
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KonsultantPlus: note Starting on 1 September, 2022 and through 31 December, 2022 evaluation of the QMS was not available. Starting on 1 January, 2023 and through 31 December, 2023 evaluation of the QMS is available and may be performed on a voluntary basis. Regarding confirmation of implementation of the QMS, please refer to. Decree of the Government of the Russian Federation No. 135 dated 09/02/2022. |
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16. Evaluation of the QMS for medical devices shall be performed for the following processes:
design and development, if included in the medical device manufacturer's quality management system;
documentation and records management;
production and output control;
corrective and preventive actions;
processes related to the consumer.
If the manufacturer of a medical device has implemented a quality management system for medical devices in accordance with the requirements of the international standardGOST ISO 13485-2017 or any other related standards, then proof of the conformity of this system (certificate of conformity issued for the system concerned by a duly accredited certification body, QMS audit reports etc.) ensures its compliance with these Requirements in terms of the processes and procedures related to the performance of the quality management system for medical devices. In this case, evaluation is limited to inspection of the adherence to the requirements related to the processes of designing and development, manufacturing and release control of the medical devices and processes related to consumers (with regard to after-sales monitoring).
17. Evaluation of the processes mentioned in paragraph 16 shall be done by means of analysis of documents and records which are the results of the implementation of the related documented processes and/or operational procedures of the QMS for medical devices, taking specific medical devices of each group and subgroup of manufactured medical devices as examples, depending on the classification of the potential risk associated with their usage as per Appendix 1 to the Rules of the organization and implementation of inspection of the production of medical devices for 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 approved by Decree No. 135 of the Government of the Russian Federation dated 09/02/2022 “On approval of the rules for the organization and implementation of an 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”
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