On March 1, 2025, updated regulations for state registration of medical devices, approved by Russian Government Resolution No. 1684, came into effect. This raised questions among market participants about the status of previously issued documents and the procedures for using the new formats.
The regulator has provided official clarifications that remove key uncertainties.
What has changed:
Previously, registration was confirmed by a paper registration certificate. Now, in accordance with paragraph 25 of the new rules, the primary confirmation is considered to be an entry in the state register. The number of such an entry is generated using a new template: Yxxx-xxxxx-хх / хххххххх .
In addition, Federal Law No. 304-FZ amended Federal Law No. 323-FZ, stating that a registration certificate is precisely an entry in the register.
Roszdravnadzor explains:
– The numbers indicated in previously issued forms (FSZ 20XX/XXXXXX, FSR, RZN) and the new registry entry numbers are equivalent.
– They have the same legal force and can be used by manufacturers at their discretion when labeling, preparing documentation and other procedures related to the circulation of products.
Conclusions for manufacturers and certificate holders
1. No replacement required: If you have a valid paper registration certificate, it remains valid. Switching to the new format is not required.
2. New registrations: When registering, a registry entry number is currently assigned. This number must be indicated in all documents.
3. Checking the status: For any transactions or inspections, it is recommended to check the product’s status in the open registry on the Roszdravnadzor website. The presence of a valid entry in the registry, not the document format, is legally significant.
