Medical device registration in Russia - a brief guide

All medical devices placed on the Russian market must be registered and compliant with local laws and regulations. Foreign manufacturers who are trying to enter the Russian medical device market might face the challenge of managing local regulatory procedures. Understanding the regulatory framework is essential for successful registration of your medical devices in Russia.

Russian medical device regulatory authorities

The regulatory body responsible for medical devices in Russia is called Roszdravnadzor. It is subordinate to the Ministry of Health of the Russian Federation. And three scientific expert institutions (so called FGBUs - Federal State Institutions) are subordinate to Roszdravnadzor. Medical device registration is the function of the Medical Device Registration and Control Department of this agency.

The Medical Device Registration and Control Department makes decisions regarding registrations and denials of medical devices in Russia. It is also responsible for changes and modification approvals, suspension and cancellation of registrations. The document that a medical device manufacturer receives if their registration has been approved is the Registration Certificate.

Russian medical device regulations

The fundamental provisions for medical devices are set forth in the article 38 of the Health Law (Federal Law 323). Another important regulations are the Decree No. 1416 Medical Device Registration Rules and Decree No. 4n Medical Device Nomenclature Classification, Ministerial Ordinance No. 11 Technical and User Documentation Requirements. 

Also, there are a number of product and product family specific standards known as GOSTs. GOST stands for "the state standard". There are national GOSTs called GOST R and GOSTs based on international standards, for instance GOST ISO.

The lowest tier standards used in Russia are industry standards and technical specifications developed by state standardization institutions. Such low tier standards may or may not be applicable to a specific product.

Medical device definition in Russia

The medical device definition in Russia is very similar to the definition used in the European Union. Under Article 38(1) the term "medical device" is defined as any instrument, apparatus, appliance, material or other article, including the software, intended by its manufacturer to be used for diagnostic and therapeutic purposes (diagnosis, prevention, monitoring, treatment, alleviation or compensation of a disease, injury or handicap), which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.

Medical device classification in Russia

In Russia medical devices are classified by type and by risk associated with their use. The type classification is determined by finding the type of the device in a special list of device types. The risk-based classification of medical devices in Russia is rule-based.

The list of device types and the rules for the risk-based classification are set forth in the Medical Device Nomenclature Classification - Ministry of Health Decree No. 4n.

Like in the European Union, there are four risk classes of medical devices in Russia - I, IIa, IIb, III.

General requirements for medical device registration documentation

For all product classes the applicant should submit to Roszdravnadzor a registration dossier compliant with provisions of the standard Technical and User Documentation Requirements (Ministerial Ordinance No. 11) including:

• Administrative documentation
• Product description and technical specifications. Description of the functional components, parts and structure of the medical device including: lists, diagrams, images or drawings of the functional components
• Description of the raw materials
• Stability and sterility reports 
• Labels and instructions for use
• Description and technical specifications of the primary and secondary packaging
• Information on the manufacturing process
• Biofunctionality reports
• IEC 60601 certificates (if applicable)
• Biocompatibility Studies based on ISO 10993 
• User documentation
• Clinical investigation plan (clinical data are submitted later - see below)

Medical device registration procedure in Russia

The regulatory approval includes two phases.

• Phase 1. Roszdravnadzor checks if the registration dossier submitted by an applicant is full and conforms with the technical and user documentation standard. After that the agency passes the dossier to the FGBU National Institute of Quality where it is reviewed. The FGBU issues its official opinion if the clinical investigation can be approved. If it is approved Roszdravnadzor puts the registration process on hold. The applicant must carry out the clinical investigation and obtain the clinical data.
• Phase 2. The applicant submits clinical data to Roszdravnadzor and applies for the continuation of registration process. Roszdravnadzor requests the clinical data review by the National Institute of Quality which issues the official opinion if the medical device may be approved and registered. If the opinion is positive Roszdravnadzor adds the record to the medical device database and issues the Registration Certificate.