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REGISTRATION OF LIMITED QUANTITY OF MEDICAL DEVICES

State registration of a limited number of medical devices is a list of measures taken with the aim of admitting to circulation of medical devices supplied in limited quantities.

Since September 4th, 2021, in the Republic of Belarus, in accordance with the Resolution of the Council of Ministers No. 504 dated September 1, 2021, a procedure of state registration and the issuance of a registration certificate for limited quantity of medical devices has been introduced:

  • supplied in limited quantities for public health organizations in order to carry out international health programs;

  • supplied for the urgent needs of state healthcare organizations, including for eliminating the consequences of natural disasters, catastrophes, epidemic diseases, in other exceptional cases, as well as for the treatment of limited patient populations, including patients with rare pathologies;

  • supplied as foreign gratuitous aid.

Process of registration

  • collection of documents of the registration dossier;

  • submission of the registration dossier to the authorized body and examination of documents;

  • conducting the necessary tests and studies of products to confirm their safety, quality and effectiveness;

  • registration of a medical device and issuance of a Registration Certificate;

  • adding of a medical device into the State Register of Medical Devices.

Scope of provided services

  • evaluation of the timing of state registration and the list of procedures based on product characteristics;

  • collection and preparation of the registration dossier;

  • translation of the registration dossier into Russian according with the requirements of the legislation;

  • support of the registration process after submitting the registration dossier to the authorized body, interaction with expert institutions;

  • support of the process of carrying out technical, toxicological and other tests (in case of appointment);

  • accompaniment of clinical trials (in case of appointment);

  • obtaining a properly executed registration certificate with preliminary control for errors, mistakes and other inaccuracies.

Thanks to a successful experience in the regulatory field, AVAKO team will help you to register medical devices with high quality and in the shortest possible time. We will provide you with the necessary information on the procedure and terms of registration (re-registration) of medical devices, collect documents for the registration dossier, assist in the passage of relevant product studies and provide all necessary support until the end of the registration procedure.

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