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;
  • registration of declarations of compliance of medical devices with the requirements of the technical regulations of the Customs Union TR CU 020/2011 Electromagnetic Compatibility of Technical Products;
  • certification of medical equipment and medical devices within the National system of conformity attestation of the Republic of Belarus;
  • 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;
  • issuance of a sales and (or) medical use permit for:
    • unregistered medical devices and medical equipment intended for implementation of international programs in the field of health care;
    • o unregistered medical devices and medical equipment supplied for emergency needs of public health care organisations, including those intended to eliminate the consequences of natural disasters, catastrophes, epidemic diseases as well as medical devices and medical equipment supplied in limited quantities in other exceptional cases;
    • unregistered medical devices and medical equipment intended for the treatment of limited contingents of patients, patients with rare pathology;
    • unregistered medical devices and medical equipment received as foreign gratuitous aid;
    • samples of medical devices and medical equipment intended for research conducted within the procedure of state registration (re-registration);
    • o unregistered medical devices and medical equipment imported into the territory of the Republic of Belarus during the period of validity of the expired marketing authorisation;
  • organisation of works on issuance of certificates on the possibility of carrying out works (services) on installation, adjustment, maintenance, and repair of medical equipment and medical devices.

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