Russian Medical Device Registration – Russia and CIS Certification Introduction to Russian Medical Device Registration
The Russian Medical Device Registration Certificate, issued by the Russian Federal Service for Health Care and Social Development Supervision (referred to as the Russian Health Supervision Service), certifies that medical devices or medical products have successfully passed the tests of Russian institutions, been registered and allowed to import, produce, sell and sell in Russia. Certificate for use in Russia. All medical device products, whether domestic or imported in Russia, as long as they are used for prevention, diagnosis, treatment, rehabilitation, medical research, replacement and modification of human tissues and organs, improvement or compensation of damaged and lost physiological functions, etc. The intended products are subject to Russian medical registration certification. If it is used for a patient’s personal customized medical product, the product needs to show the special requirements of the medical worker and the certificate that is completely used for the individual rather than the country. Such a product does not need a medical registration certificate. The export of medical devices to Russia requires a medical registration certificate and a GOST R declaration of conformity certificate issued by the Russian Medical and Health Supervision Bureau.
Russian medical device classification
Russia divides medical device products into four classes according to the potential risk of the product: Class I – lower risk class product Class IIa – medium risk class product Class IIb – high risk class product Class III – highest risk class product Currently applying for a medical registration certificate, according to the latest medical registration regulations, clinical and technical tests are required for all types of products.
Validity of Russian Medical Device Registration Certificate
The medical registration certificate is a long-term valid certificate; GOST R conformity declaration certificate: the maximum validity period is 3 years (after obtaining the medical registration certificate, you can apply for GOST R, and you can apply again after the expiration)
Russian medical device registration certificate sample
The medical registration certificate is a long-term valid certificate; GOST R conformity declaration certificate: the maximum validity period is 3 years (after obtaining the medical registration certificate, you can apply for GOST R, and you can apply again after the expiration)
