State registration of medical devices in the Republic of Belarus.
As you know, in the near future, namely from January 1, 2022, the five countries of the Eurasian Economic Union will be united by one harmonized procedure for registration of medical devices. However, most countries of the Union have their own national registration procedures. How is the state registration of MD organized in these countries? What are its features for each country? We will try to answer these questions in several articles in the section dedicated to the registration of MD, and we will begin with an analysis of the process in the Republic of Belarus.
According to the Decree of the Council of Ministers of the Republic of Belarus No. 1269, state registration of medical devices and medical equipment is the admission procedure to the production, sale and medical use of medical devices and medical equipment produced in the Republic of Belarus or coming from its borders that are recognized as meeting the requirements for safety, efficiency and quality for humans established in the Republic of Belarus;
It is interesting that the Republic of Belarus has a stage of preliminary technical work, which is necessary for the further launch of the registration (re-registration) procedure. This set of works is carried out by the RUE “Center for Expertise and Testing in Health Care” and includes the following activities:
- Initial examination of documents (verification of completeness and correctness of their execution; verification of completeness and relevance of the information specified therein) — 15 calendar days (in case of request + 45 calendar days to provide additional information)
- Preliminary technical work determined by the RUE (inspection of production for the first-time registering MD of risk classes 2a, 2b, 3; sanitary and hygienic tests; technical tests) — 150 calendar days from the date of conclusion of the contract.
- Specialized examination of documents — 15-20 calendar days (in case of request + 30 calendar days+10-15 calendar days for final specialized examination)
Further, if there is a positive conclusion of the RUE “Center for Expertise and Testing in Health Care” on the compliance of the MD with the requirements of safety, efficiency, and quality, containing the results examinations, inspections, tests and other studies, the applicant submits a registration dossier to the Ministry of Health of the Republic of Belarus. Then the Ministry of Health of the Republic of Belarus within 7 working days notifies the applicant about the decision and the need to pay the state duty. After paying the duty, the Ministry of Health of the Republic of Belarus within 5 working days issues a RC with a validity period of 5 years (after renewal RC with unlimited validity period is issued). Then, information on registered MD is included in the State Register of Public Unitary Enterprise “Center for Expertise and Testing in Health Care”.
What are the main differences between the national registration system in the Republic of Belarus from the harmonized procedure in accordance with the requirements of the EEU?
- As part of the EAEU procedure, it is possible to enter other markets of the Member States.
- Within the framework of the EAEU procedure, a RC with unlimited validity period is issued.
- The procedure for registering MD in the EAEU is faster than the national procedure (according to the terms approved by the legislation).
- Initial examination of documents will be held after completion of preliminary technical work in the frame of registration procedure.
- RESOLUTION OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS on September 2, 2008 № 1269 On state registration (re-registration) of medical devices and medical equipment
- RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS on April 23, 2015 No. 55 On the complex of preliminary technical works preceding the state registration of medical devices
- Decision of the Council of the Eurasian Economic Commission of February 12, 2016 N 46 “On the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices”