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Completion of Samsung X-Ray Medical Device Registration

관리자 · 2017-08-25
On August 25^th 2017, CERINS completed the agency business of Medical Device Registration and issuance of Medical Device Certificate by the Federal Service for Supervision of Welfare – ROSZDRAVNADZOR - on Samsung Electronics X-Ray model GR40CW. This device is subject to Class 2b – Products with Increased Risk, and the registration is valid until the according model is discontinued. In accordance with Russian Federal Law No.323-fZ 21.09.2011 “On fundamental healthcare principles in the Russian Federation”, every medical devices to be imported to Russia should obtain Medical Device Certificate under the supervision of ROSZDRAVNADZOR. The registration and certification takes about a year, since it is a very complicated process including proper clinical test in authorized Russian laboratory and review from ROSZDRAVNADZOR committee. On the basis of practical experience, CERINS Group is able to provide efficient consulting and agency service on all process of Medical Device Registration.