On March 24, 2017: the approved requirements to keeping of technical and operational documents of medical device manufacturers

Federal Service for Surveillance in Healthcare: On March 24, 2017, the approved requirements to keeping of technical and operational documents of medical device manufacturers will become effective in the territory of the Russian Federation.

The Federal Service for Surveillance in Healthcare announces that on March 24, 2017, the order of the Russian Ministry of Healthcare On Approval of Requirements to Keeping of Technical and Operational Documents of Medical Device Manufacturers (Producers) dated January 19, 2017 (registered by the Russian Ministry of Justice on March 10, 2017), will become effective.

The document determines the list of data to be specified in the technical and operational documents when a manufacturer files an application with the Federal Service for Surveillance in Healthcare for medical device registration.

Thus, the new established requirements will be applied to the technical and operational documents of medical device manufacturers (producers) filing applications for medical device registration upon the said order becoming effective (on March 24, 2017).