Registration Certificate of the Federal Service for the Supervision of Public Health and Social Development
The cost of the certification depends on the type and testing of the product, ranging from $15,000.
The processing time: 8 to 12 months.
Registration Certificate of the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) (of the Ministry of Health of the Russian Federation)
All medical devices intended for medical use in the Russian Federation are subject to registration and subsequently should obtain the Registration Certificate. From the 1st of January 2013 the registration of medical devices is based on the Decree of the Government of the Russian Federation of the 27th of December 2012 № 1416.
Certificate Prim offers registration and certification services for medical devices and medical equipment, pharmaceutical raw materials and medicinal drugs.
Our specialists are ready to assist you in gathering all the necessary documents, review the documentation, as well as make the necessary amendments, if required for the issue of the Registration Certificate.
Registration includes document preparation, testing, expert quality, efficiency and safety reports for medical devices. Also, the class of the potential risk associated with the product is determined.
Stages of the registration process:
• request to provide product samples and documents
• initial testing
• preparation of the initial set of documents for registration
• submission of the documents to the Ministry of Health of the Russian Federation and receipt of comments
• referral for clinical testing and its implementation
• examination of the full set of documents
• issue of the Permit