Quality Systems in China
Quality Systems for Medical Devices in
China
Quality Systems Pharmaceuticals/Drugs in
China
As one of the world's fastest-growing medical device and pharmaceutical markets, China offers great sourcing and manufacturing opportunities for foreign medical companies. Recent scandals, however (e.g., tainted heparin), have shown that lower-priced Chinese medical products sometimes come at the expense of quality. Excellent quality systems to comply with FDA and international standards are needed in order to sell your China-manufactured products in the West.
PBM's China quality experts can advise you on ensuring that your Chinese operations or Chinese partners comply with U.S. FDA standards (CFR 820, 210, 211), international quality standards (ISO 13485, ISO 9000, ISO 9001), or your company's internal regulatory standards.
For more information on Chinese quality issues, 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 Pharmaceutical Regulatory Report 2011 (publication for sale)
- China Pharmaceutical Market Report 2011 (publication for sale)
- China Distribution for Medical Devices/Drugs/OTC Products (webcast for sale)
- How Medical Companies Can be Successful in China (webcast for sale)
- Looking East for R&D and Clinical Trials
- 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)
- Dragon & Tiger - Emerging Power of India & China in the Pharmaceutical Industry (PDF)
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