The LIST of documents required for certification of medical products

  1. The registration certificate from the Federal Service of Health Care and Social Development Control (in the presence).
  2. The certificate GOST R of conformity (in the presence).
  3. Test reports on the given products which have been given out by accredited test laboratories in the Russian Federation (in the presence) or Test reports from manufacturer for (IEC 60601-1, IEC 60601-1-2, ISO 10993 etc.)
  4. The Power of attorney from manufacturer for certification process
  5. The contract on which import of products will be carried out
  6. The certificate confirming system of quality of manufacture ISO 9001 or 9002
  7. 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.
  8. Certificates of legal registration of manufacturer in their own country
  9. User’s manual (Russian)
  10. Advertisements
  11. Information about composition of medical product
  12. Samples (in case of need).

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