- The Power of attorney from manufacturer for registration process of medical products at the Russian Federation.
- Certificates of legal registration of manufacturer in their own country.
- The certificate confirming system of quality of manufacture ISO 9001 or 9002, 13485.
- Certificates of conformity of medical product to Directive 93/42/EEC and safety of product (EC Certificate, declaration of conformity) or documents of conformity to national standards.
Documents (1-4) should be in the notary’s copies, certified by consular establishments of the Russian Federation or with assurance the Apostille according to the Hague convention.
5. STED documentation (international standard for medical devices) or Summary Technical Documentation.
6. User’s manual (in Russian or in English. It must be translated into Russian anyway.).
Documents (5-6) should be in paper copies (original) with Manufacturer’s sign and seal (each separate document must be sewed together and the place of sewing must be authorized with seal and sign also).
7. Advertisements. Catalogues or consumable materials and accessories.
8. Photos of med. device with all accessories (18×24 cm), the photo of identification label (only for medical equipment, with the serial number). The photos should be in high resolution. The devices should be in the assembled condition.
9. Test reports from manufacturer for (IEC 60601-1, IEC 60601-1-2, ISO 10993 etc.)
10. Samples for the technical, toxicological, clinical trials.