Medizinprodukt
The medical devices regulatory system is based on regulations issued by the State Council, NMPA orders and NMPA documents that provide detailed rules for medical device registration and licensing practice. Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard (YY). The system is undergoing frequent changes and adjustments. In October 2013, more than 104 new YY Standards were released.