China Issues Amended Good Manufacturing Practice for Medical Devices
28 January 2015
The China Food and Drug Administration (CFDA) recently amended the Guidelines of Good Manufacturing Practice for Medical Devices to strengthen supervision over the production of medical devices. The amended GMP was adopted by the CFDA on 12 December 2014 and will come into force on 1 March 2015 when the existing Guidelines of Good Manufacturing Practice for Medical Devices (Trial Implementation) will be annulled.
Medical device manufacturers are required to establish a quality supervision system in accordance with the amended Guidelines. The amendment also covers provisions for organisation and personnel, premises and facilities, equipment, archive management, design and development, purchases, production management, quality control, sales and after-sale services, control of substandard products, and monitoring, analysis and reparation of adverse events. The party applying for or undergoing recordation for registration of medical devices is required to observe the relevant requirements of the Guidelines when developing these products.
For details, please read:
Announcement on the Issuance of the Guidelines of Good Manufacturing Practice for Medical Devices.