Services

Registration of medical devices

Registration of medical devices is a prerequisite for their importation to, use, sale, and manufacturing in the Russian Federation

Amendment of master files and registration certificates

The main part of the changes, as a rule, is connected with the organizational and structural transformations of the company

This is an integrated service for arranging, conducting and obtaining results of clinical trials of medical devices, including those for invitro diagnostics.

Clinical trials of medical devices

Control over circulation of medical devices

We analyze the information contained in the databases of countries where MD is addressing, as well as in the database of Roszdravnadzor for the last 5 years

Localization of medical devices

We offer foreign manufacturers and their Russian partners a full range of services for localization of production of medical devices in the Russian Federation.

Certification is mandatory for a list of products approved by the Decree of the Government of the Russian Federation No. 982 dated December 1, 2009

Certification of medical devices