Registration according to national standards

Registration of a medical device in the Russian Federation in accordance with Government Decree No. 1416 dated 30.11.2024 allows obtaining an indefinite registration certificate.
Every year, from 3 to 5 thousand new registration certificates of this type are issued in the country.

The registration stages are standard:

1. Preparation of technical and operational documentation.
2. Conducting the necessary tests — technical, toxicological, clinical, as well as tests for electromagnetic compatibility and metrological tests.
3. For high-risk class devices — conducting inspection of production sites.
4. Electronic submission of the registration dossier documents and interaction with comments from state authorities.

The process is applicable to all types of medical devices.

In our portfolio — more than 400 obtained registration certificates and hundreds of satisfied clients.