The Federal Service for Control over Healthcare and Social Development (Roszdravnadzor) is the competent authority in Russia for registration of medical devices. Foreign manufacturers of medical devices must register their product with the competent authority; obtain a GOST-R quality and safety certification and a sanitary and epidemiological conclusion.
 
The product must be defined as a medical device and classified according to the General Classification Codes for registration and Foreign Trade Classification codes for importation. Our country specific (*) regulatory services in Russia include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with Roszdravnadzor, Technical documents Preparation, obtaining GOST-R quality and safety certification, obtaining sanitary and epidemiological conclusion, Russia license holder and local Authorized Representative and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Russia!

(*) Russian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.