Quality Systems for China Medical Devices

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

Quality systems for China medical devices 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 about quality issues and China medical devices, 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)
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)