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STATE
REGISTRATION
(CHANGES TO THE DOSSIER)
OF MEDICAL PRODUCTS
IN THE REPUBLIC OF BELARUS 

State registration of medical devices is a list of measures taken in order to obtain admission to the production, sale and use of medical devices on the territory of the Republic of Belarus.

According to the current legislation of the Republic of Belarus, medical devices are allowed for production, sale and medical use in the Republic of Belarus only after their state registration.

 

Medical devices and medical equipment, both produced in the Republic of Belarus and imported from other countries, are subject to state registration.

Process of the State Registration

  • collection of documents for 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;

  • inspection control (audit) of manufacturing site (if necessary);

  • 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

  • selection of the optimal registration plan, based on the method of selling products, taking into account the specific of the products and current practice;

  • 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);

  • support of the preparation procedure for the inspection control (audit) of the production site (if required);

  • accompaniment of clinical trials (if required);

  • 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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