Chinese market
C-REG Medical provides you support to enter the Chinese marketChina Registration Partnership :
Our partners senior consultants have a rich experience with Chinese Health Authority organizations, such as the China State Food and Drug Administration (SFDA), the China Center for International Pharmaceutical Exchange (CCPIE), the Ministry of Health and other national health and medical institutions.
The experts in China have more than 6 years experience in successful registration of medical devices, including areas such as haemodialysis, parenteral nutrition and infusion, minimal invasive surgery, endoscopy and spinal surgery.
With his partners, C-REG Medical is able to offer a full range of services for a successful registration of your medical devices in the People’s Republic of China.
Typical services include :
- assisting you in understanding the SFDA requirements for medical device submissions
- identifying the correct SFDA product classification
- assisting you in preparation of formal documents (e.g. application forms, authorisation letters, quality declarations and other formal documents required)
- reviewing and completing your Technical Files according to the guidelines of the P.R. of China
- preparation of the Guo Biao Standards compliance reports
- translation of your Registration Files into Mandarin
- management of quality testing of your devices at the accredited Medical Device Testing Institutes in the P. R. of China
- preparation and conduct of pre-submission and submission meetings with the SFDA
- follow-up of the entire evaluation and administration process
- organizing and conduct of clinical studies for SFDA submissions
Within the Chinese network, having a close relation to numerous Chinese medical device distributors, we are also able to assist you in finding the right partner for sales and marketing in the P.R. of China.
For more details or to discuss other projects, please contact C-REG Medical.