In order to strengthen the management of production and supervision of medical equipment, medical equipment quality management for production, to protect public safety and effective, according to the latest release of "medical device supervision and management regulations" and "medical device manufacturing supervision and management measures", the State Food and Drug Administration for "medical device production quality management specification (Trial)" to revised standard management of medical devices in the production quality of the revised "(hereinafter referred to as the" standard ") in 2014 December 12 of the national food and drug supervision and Management Bureau seventeenth director's office will consider for adoption, in December 29th announcement, since March 1, 2015 will come into effect.

　　The revised "standard" a total of thirteen chapters eighty-four, requirements of medical equipment production enterprises to establish a sound quality management system in accordance with the "standards", and the provisions of the organization and personnel, buildings and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales, nonconforming product control, bad event monitoring, analysis and improvement aspects.

　　For the full implementation of the "standards", combined with the "standard" issued, the State Administration of food and drug supervision and management will be based on the sterile and implantable medical devices and custom denture and other special requirements of different categories of medical equipment production, specific provisions are formulated detailed, at the same time to speed up the medical device supervision inspectors ability construction, improve the ability and the level of supervision personnel, implementation and lay a good foundation for the "norm", to further improve the medical device production enterprise quality assurance level.