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New Medical Device Quality System Guidelines Released by Chinese Regulators

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The China Food and Drug Administration (CFDA), China’s medical device market regulatory agency, has published four new guidelines concerning good manufacturing practices for manufacturing facilities in the country.

CFDA guidelines for Good Manufacturing Practice quality system compliance for medical devices and IVDs in ChinaThe new CFDA guidelines cover Good Manufacturing Practice onsite inspections, onsite inspections for sterile devices, onsite inspections for implantable devices and onsite inspections for in vitro diagnostic (IVD) reagents. The publication of the guidelines follows a CFDA order issued earlier in 2015 on surprise inspections of medical device manufacturing facilities in China, also expected to target primarily domestic companies.

Emergo will report further on the new CFDA GMP guidelines and their effects on Chinese and international manufacturers as we learn additional details.

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