Regulatory Focus™ > News Articles > Russian Device Reauthorization Deadline Extended

Russian Device Reauthorization Deadline Extended

Posted 17 July 2013

Russian regulatory authority Roszdravnadzor and Russia's Ministry of Health have decided, after consulting with Russia's medical device industry as represented by the Union of Industrialists and Entrepreneurs (RSPP) and the Chamber of Commerce, to extend a deadline for reissuance of medical device registration certificates.

An amendment to Government Decision 1416 of 27 December 2012 was introduced by Deputy Minister of Health Igor Kagramanyan and was approved by the Ministry. The measure would extend the deadline for reauthorization of registration certificates from 1 January 2014 to 1 January 2017. Roszdravnadzor and the Ministry of Health also discussed ways of simplifying the registration process for low risk devices, they said in a statement.

Roszdravnadzor: Medical Device Deadline Extended

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