In Russia came into force new rules for registration of medical devices
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In Russia came into force new rules for registration of medical devices

14 January 2013

In Russia came into force new rules for registration of medical devicesOn 01.01.2013 entered into force the Government Decree of December 27, 2012 N 1416 on the approval of rules of state registration of medical devices. Previously existing administrative regulations of Roszdravnadzor, approved by Ministry of Health of October 30, 2006 N 735, expired.
Under the new rules, the medical devices registration certificates valid for an indefinite term, issued before the date of the entrance into the force of the above mentioned resolution, remain valid, but must be replaced before January 1, 2014 on the new registration certificate, issued by the Federal Service on surveillance in healthcare (Roszdravnadzor).

The medical devices registration certificates with an expiry date, issued before the date of the entrance into the force of the above mentioned resolution, remain valid until their expiration date.

The replacement of the old registration certificates is carried out without state registration of medical devices based on the application submitted by the applicant to the Federal Service on surveillance in healthcare, including the data provided by the Rules adopted by the above-mentioned decree.
The applications for state registration of medical products submitted for the state registration before the date of entry into force of the new regulations, will be processed according the already presented documents, plus the application for state registration of medical products in accordance with the new regulations requirements, approved by the Federal Service on surveillance in healthcare (Roszdravnadzor).