REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICES
The medical devices can’t be selling without approvals and permit marketing authorization in according to Law of Kyrgyz Republic No. 91 from 04/30/2003 “Medicines” and Regulation “Safety of medical products” to providing of safe application and effectiveness of medical products.
Reg Med Service provides comprehensive support and counseling associated with initial registration of medical devices in Kyrgyzstan.
- Registration/re-registration of medical devices in the Kyrgyz Republic on turnkey basis;
- Strict assurance at every stage: from preparation of registration dossier to obtaining of all required documentation;
- Altering and approving of corrections in registration dossier of medical product;
- Interaction with government bodies and advocacy of your favor;
- Counseling services;
- preparation of complete registration dossier and further supporting to obtaining of Certificate of Marketing Authorization;
- translation and development of all necessary documentation for registration dossier;
- Design services for the development of primary and secondary package mock-up.
IT IS PERMIT TO OBLIGATE REGISTRATION:
- Brand new domestic products intended for medical use;
- Imported medical products that proposed to medical use at the first time;
- Analogue of previously registered medical products that produced other manufacturer;
- Products that containing medical products.