All products of medical appointment assumed to medical application in territory of the Russian Federation and including tools, devices, complete sets, complexes, systems with software, the equipment, adaptations, dressing means, stomatologic materials, sets of reagents, control materials and standard samples, calibrators, account materials for analyzers, products from polymeric, rubber and other materials, software for medical purposes are subject of the Medical Registration in FEDERAL SERVICE ON SURVEILLANCE IN HEALTHCARE AND SOCIAL DEVELOPMENT OF RUSSIAN FEDERATION.
The list of documents for Medical Registration:
- The demand for registration medical product;
- The power of attorney which has been given out by the Manufacturer to the person, authorised on carrying out the registration;
- Data sheet on the medical product, containing a brief information on its appointment and the basic characteristics;
- Catalogue of the product;
- Documents on registration of the Manufacturer in its country and in other countries;
- Certificates for the product (if exist). .