Quality Systems for Medical Devices in China

More and more Western medical device companies are sourcing and/or manufacturing their medical devices or components in China. Hence, quality in China is a key issue.

China Medical Device Quality

China's quality systems are improving and the State Food & Drug Administration (SFDA) has issued various regulations implementing Good Manufacturing Practice (GMP) standards for all medical devices, a more strigent adverse events and recalls system, and new industry standards. In addition to the SFDA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries out safety registration, certification, and inpsection of certain medical devices to ensure quality.

Auditing a manufacturing facility or supplier is absolutely essential to ensure that the factory complies with the appropriate FDA and international standards. Pacific Bridge Medical can help conduct Chinese audits.

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

Update 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
Sourcing Medical Devices in Asia 2010 (publication for sale)
China Medical Device Regulatory Update (webcast for sale)
Entering China's Expanding Medical Device Market (webcast for sale)
Chinese Manufacturing: Scandals and Opportunities
China Product Registration and Regulatory Issues (webcast for sale)
GMP and QA for Medical Devices in China (webcast for sale)
Sourcing Medical Devices from China (PDF)