Medical Registration

Medical Device Approval is a mandatory document required for use and distribution of medical devices within the territory of the Russian Federation. It is issued only by RosZdravNadzor , the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation. It is regulated by Federal Law of the Russian Federation 323-FL dated  21.11.2011 “On healthcare principles in the Russian Federation”, by  Decree of the Government of the Russian Federation №1416 «On adoption of the state medical registration rules” and Institutional acts of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation (Roszdravnadzor).

The process of medical device registration consists of several stages:

• To obtain Permit for export – necessary for the export of the samples for registration

• To prepare technical, regulatory and legal documents and Technical File

• To arrange and hold technical, toxicological and clinical tests.
  

• To assess test results and check against compliance with current Russian standards.

• To issue the Medical Device Approval.

Usually it takes about 10-12 months to issue this document due to strict regulation regarding the set of documents to be compiled under statutory requirements. 

We render the following consulting services:

• Advice on the set of legal documents (Power of Attorney, ISO certificates, FDA, CE, Declarations of Conformity). Determination of the required HS code and type of medical device. Compliance check of the application to be submitted to RosZdravNadzor.  
• Compliance check of the documents to be submitted to RosZdravNadzor.
• Recommendations on contents of the technical documents. Compliance check of submitted technical documents. Drawing up the request to manufacturer if some documents missing.

We provide support at every stage of medical device registration process by preparing Technical File, arranging all the necessary tests and communicating with state authorities.

Please note that process of medical device registration requires constant communication between a manufacturer and a project manager.