In December 2014, the China Food and Drug Administration (CFDA) released two pieces of legislation that will further develop quality management system standards for the manufacturing and distribution of medical devices in China. The first is China’s medical device Good Supply Practices (GSP) regulations, which took effect immediately. The second is a revised medical device Good Manufacturing Practices (GMP) regulation, which will go into effect on March 1, 2015.
The new GSP regulations will require medical device distributors to implement a risk management system throughout the device supply chain, based on the risk level of the device. The revised GMP regulations will require medical device manufacturers to implement a risk management system throughout the device development, production and post-market process — also based on the device’s risk level. In the next several years, the CFDA may also start conducting GMP inspections of overseas manufacturing facilities.