SFDA issues Quality Management System Regulations and Requirements for Medical Devices (interim)
Date: 2011-07-19
In order to intensify supervision on medical device manufacturing, standardize quality management systems for medical device manufacturing, strengthen the management of medical device quality management system inspection, in accordance with Regulations for Supervision and Administration of Medical Devices and other related regulations, the State Food and Drug Administration (SFDA) formulated Quality Management System Regulations for Medical Devices (interim) and Requirements for Medical Device Quality Management System Inspection (interim).
Quality Management System Regulations for Medical Devices (interim) comprises 13 chapters, 69 articles and will take effect as of January 1, 2011.
