Regulatory Compliance for Medical Devices
LEGIA team.
More than 10 years of experience in providing registration and circulation of medical devices in the Republic of Belarus.
Specialists with extensive practical experience will work with you:
Legal team
is responsible for working with legislation and knows all regulatory processes in the healthcare sector
Medical team
with professional expertise in various fields of medicine and laboratory diagnostics
Implemented
more than 1000 registration projects
Regulatory support for the circulation of medical devices in Belarus:
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Individual selection of a team for the project;
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Registration of medical devices in compliance with the rules of Ministry of Health of the Republic of Belarus;
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Work as an authorized representative of the manufacturer on the territory of Republic of Belarus;
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Carrying out clinical, laboratory and technical tests.
We also provide the following services:
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Obtaining the EAC Declaration of Conformity according to the Technical Regulations of the Custom Union;;
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Metrology;
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Obtaining the explanatory and exemption letters;
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Obtaining the Product State Registration (EAC Hygiene Certificate).