Registration of medical devices
Import, sales and implementation of medical products in the Republic of Belarus are allowed only after official registration of them.
Registration process of medical products in the Republic of Belarus is regulated with:
- Statement № 1269 of Council of ministers of the Republic of Belarus from 02.09.2008 "Approval of regulations of State registration (re-registration) of medical products and devices"
- Statement № 254 of Ministry of Public Health of the Republic of Belarus from 01.04.2015 "Approval of statement of Federal Agency of safety in Public Health sphere related to registration of medical products and devices"
Grounds for starting registration process are application for registration and related set of documents on exact products, which is supposed to use in medical sphere.
An applicant takes full responsibility for the quality, safety and efficiency of a medical product.
Necessary documents for obtaining Registration Certificate for medical devices:
- Power of attorney for representing manufacturer during registration process
- Copy of an extract from the trade register
- Copy of ISO 13485 and/or ISO 9001
- Copy of CE certificate
- Technical information on products (catalogues, passports, test protocols, operating manuals, risks analysis, list of implemented materials, etc.) in Kazakh and Russian language with a company stamp and a signature of responsible person/employee
- Sample units for tests (if required)
Other documents can be required.
- All documents must be in Russian language
- Expert inspection of production is required depending if applicant register medical products for the first time
- Timeframe of work depends on type of product, in average it is approximately 6 months
Please, send us your request and our experts will check which certificates are required for the import of your goods to the territory of the Customs Union.