REGULATORY DOCUMENTATION FOR LOCAL REGISTRATION OF MEDICAL DEVICES WITHIN THE RUSSIAN FEDERATION
- RF Government Resolution dd. December 27, 2012 No.1416 "On approval of the rules for state registration of medical devices" (as amended on 18.03.2020)
- RF Government Resolution dd. April 01, 2022 No. 552 "On approval of the specifics of circulation, including the specifics of state registration, of medical devices in the event of their defect or the risk of defect in connection with the introduction of restrictive economic measures against the Russian Federation character" “On approval of the specifics of circulation, including specifics of state registration, of medical devices in the event of their defects or risk of defects in connection with the introduction of restrictive economic measures against the Russian Federation”
- Order of the Ministry of Health of Russia dd. August 30, 2021 No.885n "On approval of the Procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices"
- Order of the Ministry of Health of Russia dd. October 19, 2020 No.1113n "On approval of the Procedure for reporting by subjects of medical devices circulation on all cases of detection of side effects not specified in the instructions for use or operating manual for a medical device, on adverse reactions during its use, on specifics of the medical devices interaction, on facts and circumstances creating a danger to the life and health of patients and healthcare professionals during the use and operation of medical devices"
- RF Government Resolution dd. February 09, 2022 No.135 "On approval of the rules for organizing and conducting inspections of the medical device production for its compliance with the requirements for implementation, maintenance and assessment of the quality management system for medical products depending on the potential risk of their use" (as amended on 29 December, 2022)
- RF Government Resolution dd. February 09, 2022 No.136 "Requirements for implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their use"
- Nomenclature classification of medical devices by type
REGULATORY DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES WITHIN THE EAEU
- Decision of the Eurasian Economic Commission Council dd. February 12, 2016 No. 46 “On the Rules of registration and professional examination of the safety, quality and efficacy of medical products”
- Decision of the Eurasian Economic Commission Board dd. July 24, 2018 No.123 "On the Criteria for including in a single registration certificate several modifications of a medical device related to one type of medical device in accordance with the Nomenclature of Medical Devices Applied in the Eurasian Economic Union"
- Recommendations of the Eurasian Economic Commission College dd. October 08, 2019 No.29 "On Methodological Recommendations regarding the content and structure of documents contained in the medical device registration dossier"
- General safety and performance requirements for medical devices, requirements for their labeling and operational documentation approved by Decision of the Eurasian Economic Commission Council dd. February 12, 2016 No.27
- Decision of the Eurasian Economic Commission Council dd. November 10, 2017 No.106 “Requirements for implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their use”
