July 4, 2022
QMS inspection of medical device manufacturers
Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below:
| No. | Item | National system | EAEU |
| 1 | Main document |
Decree of the Government of the Russian Federation No. 135 dated 09.02.2022 “On approval of the Rules for arranging and conducting inspections of the production of medical devices for compliance with the requirements for the implementation, maintenance and evaluation of a quality management system for medical devices, depending on the potential risk of their use”
Note: In general, the inspection under the Decree refers to the procedure for making amendments to the documents contained in the registration dossier (if such a procedure requires an inspection of quality, safety and efficiency or amends information about production sites), as well as to the verification of the QMS of production facilities that manufacture customized medical devices |
Ruling of the Council of the Eurasian Economic Commission No. 106 dated November 10, 2017 “On the Requirements for the implementation, maintenance and evaluation of a quality management system for medical devices, depending on the potential risk of their use” (as amended by a Decision of the EEC Council No. 131 dated November 12, 2021 “On Amendments to Requirements for the implementation, maintenance and evaluation of a quality management system for medical devices, depending on the potential risk of their use”) |
| 2 | Partial/full effect of inspection requirements |
Partial effect from 01.01.2022 (without conducting an inspection at the current time, but with an unscheduled inspection within 2 years), full effect from 01.06.2023 (with an inspection).
Note: if amendments to the documents contained in the registration dossier were not made before 01.06.2023 (not “confirmed” by the Federal Service for Surveillance in Healthcare (Roszdravnadzor)), the text of the Decree implies that an inspection will be required now, and not within 2 years |
Full effect from 15.03.2019 |
| 3 | Mandatory inspection |
Class IIa sterile, Class IIb and Class III Note: hereinafter, regardless of whether it is related to in vitro diagnostics or not |
Class IIa sterile, Class IIb and Class III Note: hereinafter, regardless of whether it is related to in vitro diagnostics or not |
| 4 | Voluntary inspection | Class I or Class IIa non-sterile | Class I or Class IIa non-sterile |
| 5 | Application of inspection results to groups/subgroups of medical devices | Application; groups for Class I and Class IIa (sterile and non-sterile), subgroups for Class IIb and Class III; the list of groups / subgroups is equivalent to the national and EAEU systems | Application; groups for Class I and Class IIa (sterile and non-sterile), subgroups for Class IIb and Class III; the list of groups / subgroups is equivalent to the national and EAEU systems |
| 6 | Frequency of scheduled inspections | At least once every 5 years | At least once every 3 years |
| 7 | Time of initial inspection | Not specified exactly, except for amendments to information about production sites; in this case, before submitting an application for amendments to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) | When conducting an inspection after the start of registration |
| 8 | Total duration | The total period for the production inspection shall not exceed 90 working days from the date of filing an application for a production inspection | The period for arranging and conducting the production inspection shall not exceed 90 working days in total from the date of the decision to start the production inspection |
