Registration of medical devices in Kyrgyzstan

Kyrgyzstan has launched a massive reform of its healthcare system and first of all, it is aimed at increasing first aid availability. Nowadays, budgetary expenses for the first aid in the country are up to 1% of the GDP, and the government prioritized these allocations. 

In 2014, the country entered the EAEU, but being within the transition period, the national system of MD registration is still valid. 

According to the national system, the main responsibility for the registration lies on the Department of PP and MD, a subsidiary of the Ministry of Health. The Department has laboratories and inspectors in its structure. It is interesting to know that there is no national institution of clinical trials - the national registration system accepts “third-party” protocols.  

To initiate the registration process, you will need to submit the registration dossier and samples to the Department. In 10 days you will receive a conclusion and if it is positive, you will be required to pay the registration fee. Then, you will be redirected to the expertise for safety, efficacy and quality of the medical device - this expertise can be divided into 2 parts: specialized and analytical documentary if needed. At this stage, the Department specifies if an inspection of the manufacturing site is needed, which may add extra 90 days to the procedure. The registration process shall be processed only by an authorized representative with the local residence, and all submitted documents shall be in Russian. The national registration certificate has no expiry date.