registration of honey products Belarus
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What medical devices are subject to registration
Medical products are products for prophylaxis, research, diagnostics, rehabilitation and treatment. For example, hemostats, gloves, syringes, catheters, canes. Auxiliary materials (containers, packaging, fixtures, etc.) are also classified as such products. Registration is required for medical devices that:

first created and not previously used in the Republic of Belarus;
are analogues of previously registered, but from another manufacturer;
will be used for a new indication;
foreign production and first used in the Republic of Belarus.
In this list, products of domestic and foreign production are not in vain. This affects the registration process. Registration is not necessary for the following medical devices:

produced in the Republic of Belarus by order of foreign legal entities, but intended for use outside the Republic of Belarus;
accessories and spare parts for already registered products;
raw materials and materials for products manufactured in Belarus;
for which permission of the Ministry of Health of the Republic of Belarus for distribution, application in the Republic of Belarus;
imported into the Republic of Belarus by an individual for personal use only.
Since different materials are used for the manufacture of such products, their purpose differs, it is necessary to refer to the relevant standards and norms during the registration process or in preparation for it.

registration of honey products Belarus
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How is the registration
8 stages of registration of medical devices in the Republic of Belarus

The procedure is obligatory for medical products of foreign and domestic production.

1. Apply
If you are an importer or manufacturer, then you need to contact the Unitary Enterprise "Center for Expertise and Testing of Health Care", which registers medical devices in Belarus.
2. Collect all necessary documents.
You will need regulatory and operational documentation.
3. Submit them for initial analysis.
Experts review the documentation and determine the need for various tests and / or inspection control of production.
SHOW ALL STAGES

To register the registration of medical products, you must follow the procedure from the above-mentioned decree of the Council of Ministers of the Republic of Belarus. The applicant may be a legal entity or an individual entrepreneur. At the same time, he may be the customer of manufacture, and not the direct manufacturer. The applicant will face the following stages of registration of medical devices:

Registration of the registration dossier and its submission to a specialized organization.
Primary examination of documentation.
Inspection of production (if a new manufacturer of medical products of classes 2 and 3 of danger).
Conducting various tests: technical, sanitary and hygienic, clinical.
Conducting specialized expertise of documentation.
Decision on registration by the Commission of the Ministry of Health of the Republic of Belarus.
Registration of the registration certificate.
Logging into the database.
Getting a certificate.