China Compulsory Certification (CCC) under China Quality Certification Center (CQC)

The China Quality Certification Center (CQC) is responsible for issuing the China Compulsory Certification (CCC) mark on medical devices. CCC mark applies to a handful of medical devices such as medical diagnostic X-ray equipment, electrocardiographs, cardiac pacemakers, etc.

Applying for the CCC mark is required in addition to SFDA registrations for specified medical devices. The CCC mark application process includes type testing of the medical device and a facility audit from the CQC.

PBM can help determine if your product needs a CCC mark and assist with the registration process.

For more information on medical device/CCC 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
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)

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