State re-registration of medical devices in Belarus

Re–registration of medical devices is a procedure for confirming the quality, safety and effectiveness of medical devices and medical equipment for compliance with current norms and standards, in order to permit import and release into circulation on the territory of the Republic of Belarus

- Uzbekistan

In which cases are medical devices subject to state registration?

The re–registration of medical devices is regulated by the Law of the Republic of Belarus of 18.06.1993 No. 2435-XII "On Healthcare" and the Resolution of the Council of Ministers of the Republic of Belarus of 02.08.2008 No. 1269 "On approval of the Regulations on state registration (re-registration) of medical devices and medical equipment".

Medical devices that have passed the state registration procedure before 07/25/2022, but not earlier than 1 year after receiving the Registration Certificate, are subject to re-registration.

Stages of state re-registration of medical devices

STAGE 1

Preparation of the registration dossier

collection of a package of documents of the registration dossier

STAGE 2

Preliminary analysis of the registration dossier

evaluation of the dossier with adjustments (if necessary)

STAGE 3

Submission of an application for the procedure

to the state body for the conclusion of a contract for the primary examination of documents

STAGE 4

Primary examination of documents

with the issuance of a conclusion based on the results of the primary examination

STAGE 5

Sanitary-hygienic and technical* expertise (if necessary)

with the provision of samples and receipt of test certificates (* only for medical products manufactured in Belarus)

STAGE 6

Clinical trials (if necessary)

in clinics (mainly for medical products manufactured in Belarus)

STAGE 7

Specialized examination of the dossier

by specialized specialists of the Ministry of Health of the Republic of Belarus with the issuance of a conclusion on the compliance of medical products with quality, safety and efficiency requirements

STAGE 8

Session of the Commission on Medical devices of the Ministry of Health of the Republic of Belarus

with the adoption of a decision on the state re-registration of medical products and the issuance of a Notification letter

STAGE 9

Issuance of a registration certificate

with the placement of information in the State register of medical devices of the Ministry of Health of the Republic of Belarus

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