In accordance with the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 medical devices are allowed for use in the member states of the Eurasian Economic Union (Belarus, Russia, Kazakhstan, Kyrgyzstan and Armenia) only after registration.
According to the demands of the Eurasian Economic Union the registration of a medical device is possible only after conducting the complex studies of said device in the authorized research institutions located in the territory of the Eurasian Economic Union and obtaining the reports on said studies from these institutions. After submission of the registration dossier and its preliminary expertise the Centre of Examinations and Tests in Health Service requests to conduct the inspection of a manufacturing site of a medical device with the departure to the plant.
The procedure of registration is divided into the following stages:
- Technical studies (for any type of medical device);
- Studies of assessment of biological effect (for medical devices used by contacting with the human body);
- Studies for approval of type of measuring instruments (for measuring medical devices only);
- Clinical studies (for any type of medical device except for class 1 for in vitro diagnostics);
- Registration procedure (for any type of medical device);
- Inspection of a manufacturing site (for any type of medical device).
In the presence of own clinical studies published in the specialized magazines and/or in WHO Reports according to the WHO prequalification project and/or in the presence of own clinical studies conducted until January 1, 2016 in accordance with the recommendations of the International Forum of Medical Devices Regulators (IMDRF), it is possible to register such medical device without conducting one more clinical study in the territory of the Eurasian Economic Union.
According to the demands of the Eurasian Economic Union a foreign manufacturer must have its authorized representative with registered office in Belarus and provide this information in the registration dossier.
What is required for registration
For conducting the complex studies and the further procedure of the registration it is necessary to submit the following:
1) Application form with the attached documents:
- legalized Power of Attorney from the manufacturer to the authorized representative registered in Belarus;
- Power of Attorney from the authorized representative to the representative in respect of regulatory affairs actions;
- legalized copy of the Manufacturer's Authorization (Production License) issued by the competent authority of country-manufacturer;
- legalized copy of Certificate ISO 13485 together with a certified copy of last report (if available);
- Declaration of Conformity concerning safety and efficiency of a medical device or other equivalent document;
- legalized copy of CPP (Free Sale Certificate) on a medical device or legalized copy of its registration certificate issued by the competent authority of country-manufacturer;
- certified copies of registration certificates issued by the competent authorities of countries, where said medical device is registered (if available).
2) Registration dossier according to the requirements of the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46.
3) Samples of a medical device and standard samples if applicable.
Inspection of a manufacturing site
Concerning the requirements on the inspection of a manufacturing site, the requirements of the Eurasian Economic Union for conducting said inspection are complied with the requirements for obtainment of international Certificate ISO 13485. Additionally, said inspection will cover the processes of design, development, production and final control of a medical device and processes related to the consumer (in terms of post-sale monitoring). In the presence of the international Certificate ISO 13485, the inspection will cover only the processes of design, development, production and final control of a medical device and processes related to the consumer. In this case it is necessary to provide its legalized copy and the inspection report in the registration materials.
As the result of the inspection the authorized institution issues the official report on compliance or non-compliance with the demands of the Eurasian Economic Union including the official conclusion. The validity of said report is 3 years from the date of its issuance. Also, it is possible to conduct 1 general inspection in respect of several medical devices declared for registration in Belarus.
According to the demands of the Eurasian Economic Union all the required complex studies may be conducted simultaneously before submitting the application for registration to the Centre of Examinations and Test in Health Service. The timeframe of conducting said studies depends on type of a medical device and may be assessed after submitting all the required documents. The registration procedure should be conducted within about 70 working days without considering the time required for preparation of responses to remarks as well as for inspection of a manufacturing site.
The Eurasian Certificate about registration of a medical device in Belarus issued according to the demands of the Eurasian Economic Union is valid on the permanent basis. The procedure of registration of a medical device conducted according to the demands of the Eurasian Economic Union allows registering said medical device simultaneously in other member states of the Eurasian Economic Union by the centralized procedure.
In order we could provide you with the information on costs associated with registration of medical devices in Belarus together with the detailed information and list of documents required from your side, as well as a Power of Attorney form for execution, etc. please contact our specialists directly.