New medical device quality system guidelines released by Chinese regulators

By Stewart Eisenhart, Emergo Group

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.

The 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.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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