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).

On 31/08/2023, following the updating of the list of products subject to mandatory certification on Russian territory and the revision of the technical standards, the transitional period within which it was possible to import and distribute products without product certification on the Russian market ended. We remind you that this type of certification (commonly known as GOST R certification) still exists in the Russian Federation, although it is destined to be gradually replaced by the EAC certification of the Eurasian Community.

Russian Government temporarily simplified product certification procedures and automatically extended the validity of certificates and declarations of conformity to support the domestic economy within the sanctions context by adopting Decree No. 353 of 12/03/2022. Certification bodies were given the opportunity to postpone the factory periodic inspection or conduct it remotely by video conferencing services. The control and supervision activities of Russian National Accreditation Body to suspend or invalidate certificates and declarations of conformity have been temporarily suspended.

The requirement of the GLN and GTIN codes was introduced for the first time in the Russian certification field with the order of the Ministry of Economic Development of the Russian Federation of 31.07.2020 No. 478. This order sets out an EAC declarations of conformity registration procedure in the Russian national database. For manufacturers outside the Eurasian Union, in addition to the data usually entered, the obligation to enter GLN and GTIN code was introduced starting from 01.01.2021 (date of entry into force of the aforementioned order).