Belarus – Regulation for medical devices
- National State Registration for medical devices (see below).
- EAC MED mark – single market for medical devices (by link).
National regulation system | Regulatory framework
Ministry of health resolution of the Republic of Belarus No 216 dated December 18, 2008 ON SOME QUESTIONS OF CLINICAL TRIALS MEDICAL SUPPLIES AND MEDICAL EQUIPMENT (in the red. Ministry of Health Decree of 05.03.2010 N 24)
Resolution of the council of ministers of the Republic of Belarus No. 1269 dated September 2, 2008 ON APPROVAL OF REGULATIONS ON STATE REGISTRATION (RE-REGISTRATION) OF MEDICAL DEVICES AND MEDICAL EQUIPMENT
Stage 1. You send request for quotation to BeAWire with MD description. The cost depends on risk class.
Stage 2. List of documents of registration dossier is formed based on safety class. Documents of registration dossier must include an authentic translation of all the documents into Russian. BeAWire submits RD in Center for Examinations and Tests in Health Service.
Stage 3. Upon review of the documents submitted by the applicant, the Ministry of Health shall make the decision on state registration (re-registration) of medical devices and medical equipment or the decision on denial of state registration (re-registration) of medical devices and medical equipment indicating reasons for denial. The decision shall be made in the form of the Order of the Ministry of Health. (1269 resolution)
Stage 4. Factory inspection is provided mostly in two cases: first entry into a market and in case with medical devices which required special condition for installation and maintanance (MRI, X-Ray). Usually 3 experts (physicians and engineers) go to the factory site for 3 days.
Stage 5. Samples are required.
Stage 6. Samples are required.
Stage 7. Participating patients (volunteers) as subjects in a clinical trial is not required for MD that do not have direct contact with the patients body. In these cases the trials may be performed on a samples, that the applicant is provided in the clinical center.
Stage 8. Registration certificate valid for 5 years.