In order to intensify supervision on medical device manufacturing, standardize quality management systems for medical device manufacturing, strengthen the management of medical device GMP inspection, in accordance with Regulations for Supervision and Administration of Medical Devices and other related regulations, the State Food and Drug Administration (SFDA) formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim).

Good Manufacturing Practice for Medical Devices (interim) comprises 13 chapters, 69 articles and will take effect as of January 1, 2011.