Chinese Regulators Release New Chinese Medical Device Quality System Guidelines
Thursday, October 22, 2015
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.