To promote the implementation of the Good Manufacturing Practice for Medical Devices, strengthen the supervision and management of medical device manufacturing, and offer guidance to regulatory departments' GMP on-site inspection to medical device manufacturers and evaluation of the inspection results, China Food and Drug Administration (CFDA) recently formulated and issued the Guideline for Medical Device Good Manufacturing Practice On-site Inspection, the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Sterile Medical Devices, the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Implantable Medical Devices, and the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for In Vitro Diagnosis Reagents in accordance with the Good Manufacturing Practice for Medical Devices and its related appendixes.

For more detail information, please visit CFDA Chinese version website: http://www.sda.gov.cn/WS01/CL0051/131379.html