Belarus Minzdrav Guide for Medical
Berlarus Market Access for Medical Device
REGULATORY AGENCIES
- Ministry of Health of the Republic of Belarus, Department of Medical equipment, logistical support and construction
- Center for Examinations and Tests in Health Service Republican Unitary Enterprise
REGULATIONS
- Approval of medical products is mandatory.
- Resolution No. 1269 from 2 September 2008 includes requirements for registration/renewal of registration.
- Resolution No. 1324 from 16 January 2014 includes requirements for classification.
- Resolution No. 41 form 15 April 2009 includes requirements of documentation.
- Medical products in Belarus are divided into four risk classes (I, Ila, Ilb and III) based on risk level.
GUIDELINES
- The registration certificate can be issued with the name of the manufacturer or local representative.
- A registration certificate will be issued upon submission of a satisfactory registration dossier.
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