China Medical Device Registration
If you're interested in China medical device registration, we can help. The Chinese medical device market is worth about $7.5 billion. China medical device regulations are overseen by 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 for China medical device registration
China Medical Device Regulations
For more information on medical device registration in China, please see the following PBM publications and/or contact us to discuss your specific needs.
- China's Medical Device Regulatory Update 2011 (webcast for sale)
- China's Medical Device Market Update 2011 (webcast for sale)
- China Distribution for Medical Devices/Drugs/OTC Products (webcast for sale)
- China Medical Device GMP Regulations Update
- Quality Assurance for Medical Devices in China (webcast for sale)
- How Medical Companies Can be Successful in China (webcast for sale)
- 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)
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