Medical device approvals in Russia

In the Russian Federation, medical devices and medicines, their circulation and use, as part of the turnover, are controlled by the State - this is a part of the basic principle of Healthcare, therefore special approval documents are required for the circulation of medical devices.

What is turnover of a medical device? 

product sale,import and customs clearance (for foreign manufacturers), production of medical devices (for manufacturers from the Russian Federation), intended use, utilization and maintenance, etc. 

We offer services on registration of:

Registration certificate of Roszdravnadzor (the main document required for the circulation of a medical device within the framework of the national regulatory framework in Russia) - according to the main scheme for the initial registration of the document, as well as under accelerated registration schemes, declarations of conformity according to GOST R and TR CU (TR TS) (if necessary), checking the classification and developing the requirements for a medical device, registration certificate of Roszdravnadzor for in vitro diagnostic devices.