Russia. The procedure for performing trials of medical devices for the state registration purposes has been approved

The procedure was approved in respect of performing technical trials, toxicological and clinical trials of medical devices for the purposes of their state registration. On April, 3 the corresponding Order No. 2n of the Ministry of Healthcare of Russia dated January 9, 2014 was registered with the Ministry of Justice of Russia.

Based on the results of the compliance assessment, the following documents should be drawn up:

• assessment report of the results of technical trials of the medical device,
• assessment report of the results of technical trials of the medical device for in vitro diagnostics,
• conclusion on the results of toxicological trials of the medical device;
• assessment report of the results of clinical trials of the medical device;
• assessment report of the results of clinical trials of the medical device for in vitro diagnostics.

Source: KPMG-Russia