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 From 01/01/2024, the mandatory inspection of the production site is introduced for manufacturers of medical devices belonging to risk class IIa (sterile), IIb and III, consisting of a verification of the quality management system documentation and an inspection of the medical device production plant. The inspection service will be provided on a contractual basis by one of the two public bodies controlled by Roszdravnadzor (Medical Devices Market Surveillance Authority).
In Russia, until 01/01/2022, to carry out the medical devices manufacturing activity, a specific authorization issued by the aforementioned supervisory authority was required. The authorization requirement only concerned domestic manufacturers. For foreign manufacturers it was sufficient to have ISO 9001 certification (class I and IIa non-sterile) or ISO 13485 (for the remaining risk classes).
After 01/01/2024 the inspection of the production site became mandatory for all manufacturers, including both national and foreign ones.
Only the essential medical devices referred to in the Legislative Decree Govt. RUS No. 552 of 04/01/2022 are excluded from the site inspection requirement.
The inspection remains optional for risk classes I and IIa (non-sterile). In this case, if carried out voluntarily, it allows to enjoy the benefit consisting in the possibility of making an unlimited number of changes to the registration certificate with simplified methods during the validity period of the last audit report (5 years).
For inspection purposes, medical devices are divided as follows:
- by macrocategory: class I and IIa (non-sterile)
- by macrofamily: class IIa (sterile), IIb and III
The inspection can be initial, periodic and extraordinary.
The initial inspection must be carried out before submitting the application for registration of the medical device.
The periodic inspection must be done every 5 years.
The extraordinary inspection is carried out in the following cases:
- change of production site;
- additional of a new medical device macrocategory or macrofamily products to the list of medical devices;
- following the elimination of non-conformities found during the initial/periodic inspection;
- following the elimination of the causes that led to the placing on the market of defective medical devices;
- following implementation of the quality management system.
Manufacturers of class IIa (sterile) and IIb medical devices must implement and maintain a quality management system including:
- documentation and recording management procedures;
- production control procedures, monitoring and measurement of products (outgoing controls);
- preventive and corrective actions;
- consumer-related processes.
Manufacturers of class III medical devices and custom-made implantable medical devices, in addition to the above procedures, must also implement and maintain design and development procedures.
For manufacturers with a management system certified according to ISO 13485, the inspection will be limited to verification of design and development processes, production control, product monitoring and measurement (output controls), consumer-related processes (limited to post-marketing surveillance).
The number of members of the inspection commission will be established based on the size of the company.
The maximum cost of inspecting a foreign production site cannot exceed 3,069 million rubles (approximately 31.200 EURO).
Normative references:
Legislative Decree Govt. RUS No. 136 of 09/02/2022: requirements for the quality management system of medical device manufacturers
Legislative Decree Govt. RUS No. 135 of 09/02/2022: methods of carrying out the management system audit
Order of the Ministry of Health No. 91n of 18/02/2022 containing the price list for management system audits |
