RegMed-Consult

We offer legislation any medical devices, equipment, accessories in the Russian Federation Medical devices – these are products subjected to obligatory registration by Roszdravnadzor (Department of Ministry of Healthcare and Social development of Russian Federation) (According to Order № 1416 of 27.12.2012). Existing legislation of RF provides several obligatory requirements which medical devices and equipment must suit to. Medical purposes items manufactured on the territory of Russia or imported to Russia for sale must be registered in Russia for further turnover. Registration procedure The Russian medical device registration process is complicated. The state registration of medical devices is carried out on the basis of results of technical tests, toxicology studies, clinical trials, is a form of conformity assessment of medical devices with the classification depending on the potential risk of their application, and examination of the quality, effectiveness and safety of medical devices, as well as tests for type approval of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of traceability, the list of which is approved by the Ministry of Health of the Russian Federation). Obtaining Registration Certificate of any medical device presupposes successful realization of several kinds of local tests: Technical, EMC tests Toxicology tests Clinical trials Expertise of medical device registration dossier Essential part of medical equipment registration is their classification by GOST R 51609. Depending on parts amount and building complicity all complicity medical devices are divided to 4 danger classes depending on their potential risk of use in medical purposes • Class 1 – low risk; • Class 2a – medium risk; • Class 2b – increased risk; • Class 3 – high-risk.