The list of necessary documents for registration (re-registration) of medical devices and medical equipment of foreign origin on the territory of Belarus.

  1. Power of Attorney issued by the manufacturer to the authorized company for carrying out registration process on the territory of Belarus (prescribed form).
  2. The certificate confirming system of quality of manufacture (for example, ISO 9001, 13485).
    Documents (1-2) 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.
  3. Documents, confirming quality of the medical devices, medical equipment (for example, certificates of conformity for products, certificates of free sale, the declaration of conformity the manufacturer, the registration certificate).
  4. The obligation on the implementation of installation, repair, warranty and service of the claimed medical devices and medical equipment, signed by the manufacturer.
  5. The layout of the passport, instructions for use of medical devices or manual of medical technology, information about the warranty period.

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