Registration of medical devices Kyrgyzstan
Registration of medical devices is confirmed by the issuance of a registration certificate of state registration of a medical device (hereinafter referred to as the registration certificate) according to the procedure approved by the Government of the Kyrgyz Republic
What types of medical devices need to be registered?
According to Law of the Kyrgyz Republic No. 166 dated 21 June 2017 “On the Circulation of Medical Devices”, medical devices are subject to state registration in the Kyrgyz Republic if they have confirmation with regard to their circulation as medical devices in the manufacturing country or in other countries and have received a positive expert assessment of their safety, quality and effectiveness, taking into account the class of the potential risk associated with using the medical devices.
All medical devices are subject to state registration within the territory of the Kyrgyz Republic, except for:
- Medical devices manufactured in the Kyrgyz Republic according to individual orders exclusively for personal use
- Samples of medical devices, which are intended for state registration, and standard samples of medical devices
- Medical devices imported for research (testing), including for scientific purposes
- Medical devices, including as part of medical kits and packages imported through humanitarian assistance in emergency situations and/or military conflicts, according to the procedure established by the Government of the Kyrgyz Republic
- Medical devices included in the list of medical devices, the import and use of which within the territory of the Kyrgyz Republic are permitted without registration, including medical devices to provide the population with essentials in an emergency situation, a state of emergency. The procedure for drawing up the list and the inclusion of medical devices in it shall be determined by the Government of the Kyrgyz Republic
- Spare parts and consumables for medical devices previously imported into the territory of the Kyrgyz Republic and not registered
- Medical devices for demonstration at exhibitions without the right to sell them
- Medical devices imported by individuals into the territory of the Kyrgyz Republic for personal use according to the procedure determined by the Government of the Kyrgyz Republic
- Medical devices imported into the territory of the Kyrgyz Republic to provide medical assistance to passengers, crew members and drivers of foreign vehicles and train crews arriving in the territory of the Kyrgyz Republic
- Medical devices imported to provide medical care to participants in international cultural and sporting events and participants in international expeditions
- Medical devices that international medical and sanitary units and international sanitary and epidemiological teams intend to directly use in the provision of medical services to the population affected by an emergency and/or military conflicts