Contacts

The department carries out:

  • organisation and conduct of a set of preliminary technical works associated with the expert examinations, inspection of industrial production of medical devices and medical equipment, testing and other research prior to the state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier of medical devices and medical equipment previously registered in the Republic of Belarus;
  • organisation and carrying out a set of preliminary technical works prior to state registration (confirmation of state registration) of biomedical cell products, introduction of amendments to the registration dossier of biomedical cell products previously registered in the Republic of Belarus;
  • issuance of duplicate copies of marketing authorisations for medical devices and medical equipment;
  • organisation and carrying out quality, safety and effectiveness of medical devices (medical equipment and medical devices) monitoring in the territory of the Republic of Belarus and the Eurasian Economic Union;
  • organisation of works on issuance of certificates on the possibility of carrying out works (services) on maintenance and repair of medical equipment.

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