Registration of medical devices in the Republic of Kyrgyzstan.
The Kyrgyz Republic, along with Kazakhstan, Belarus, Armenia and Russia, is part of the Eurasian Economic Union, which means that from 01.01.2022 on the territory of this country the rules for registration of medical devices defined by the legislation of the EAEU will come into force. However, unlike, for example, Armenia, Kyrgyzstan has a national registration system for medical devices, regulated by the Law “On Circulation of Medical Devices” dated August 2, 2017 No. 166 and Resolution of the Government of the Kyrgyz Republic dated July 5, 2018 No. 311.
According to the Law “On Circulation of Medical Devices”, the registration of medical devices (MD) is a procedure for confirming the compliance of a medical device with quality requirements, safety and efficiency for its circulation. Compliance with the requirements is assessed by the Administration for Quality Assessment of Medicines and Medical Devices of the Department of Medicines and Medical Devices under the Ministry of Healthcare and social development of the Kyrgyz Republic (authorized body).
To register a MD according to national requirements, the applicant must submit to the authorized body:
- Application for state registration of MD;
- MD registration dossier;
- Samples of MD in the amount necessary for research (testing) in accordance with the requirements of the standards for a medical device.
- Specific reagents in the amount necessary to conduct research (tests) in accordance with the requirements of the standards for a medical device.
State registration is carried out within a period of no more than 90 calendar days from the date of receipt of the application and includes the following stages:
1. Assessment of the volume and completeness of the registration dossier documents, as well as establishing the compliance of the potential risk class for the use of a medical device with the class specified by the manufacturer in registration dossier documents — 10 w.d. (+ 35 w.d. in case of request).
2. Payment of state duty by the applicant — 21 w.d.
3. Examination of the safety, effectiveness and quality of medical devices, which includes analytical and specialized expertise.
3.1 Analytical examination of MD (with the exception of products for in vitro diagnostics) includes technical tests and studies (tests) with the purpose of assessing the biological effect, as well as verifying the reproducibility of methods for analyzing registration samples — no more than 30 w.d.
Analytical examination is not carried out in cases of MD registration that have been assessed by regulatory authorities of the countries of the European Union, Australia, Canada, Japan and the United States of America;
– medical devices that have been prequalified by WHO;
-additional modification and size of a previously registered medical device.
3.2 Specialized expertise of the MD is carried out for the scientific assessment of the safety and effectiveness of the MD and the risk/benefit ratio of MD. As part of a specialized examination, an inspection of the manufacturing site can be initiated (+ 90 w.d.) .
4. Decision on MD state registration and preparation of RC – 13 w.d.
From the abovementioned, it can be concluded that the system of state registration of the Republic of Kyrgyzstan is well-ordered. Its main differences from the EAEU registration system are:
- Stages — within the framework of state registration, payment of the state duty is made after assessing the volume and completeness of the dossier; all types of tests are carried out within the framework of analytical examination after submission of the registration dossier.
- The number of examinations is 2 within the framework of state registration, and 1 within the framework of the EAEU procedure.
- As for the timing, the range “from – to” in theory is approximately the same.
1. Resolution of the Government of the Kyrgyz Republic dated July 5, 2018 No. 311 “PROCEDURE FOR state registration of medical devices, examination of safety, quality and effectiveness medical devices, maintaining the State Register of Medical Devices, maintaining the nomenclature of medical devices, amending the registration dossier of medical devices, suspending registration certificate”