Medical Device Registration in China

If you're interested in medical device registration in China, we can help. The Chinese medical device market is worth about $7.5 billion. The regulator of medical devices in China is the State Food and Drug Administration (SFDA), which handles medical device product registration as well as many other regulatory issues.

All imported medical devices registered in China (including Class I medical devices) must be approved directly by the SFDA before they can be marketed. Certain medical devices must also receive China Compulsory Certification (CCC) from the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).

PBM can act as your legal and after sales agent in China.

For more information on medical device registration in China, please see the following PBM publications and/or contact us to discuss your specific needs.

Updates on China's Medical Device Market 2010 (webcast for sale)
China Drug and Device Regulatory Update 2009
Looking East for R&D and Clinical Trials
China Medical Device Regulatory Update (webcast for sale)
Entering China's Expanding Medical Device Market (webcast for sale)
China Product Registration and Regulatory Issues (webcast for sale)
Product Registration and Other Regulatory Issues in China
Strategies for Success in China, Japan, and India (webcast for sale)
Medical Device Regulatory Update: China and Japan
Chinese Medical Device Regulations (webcast for sale)