In order to strengthen the supervision and management of the production of medical devices, standardize the quality management of the production of medical devices, and to further protect the safety and effectiveness of the public use of devices, according to the newly issued "Regulations for the Supervision and Administration of Medical Devices" and "Measures for Supervision and Administration of Medical Device Manufacturing," the State Food and Drug Administration (SFDA) has organized a revised "Code for Quality Management of Medical Device Manufacturing (Trial). The State Food and Drug Administration has revised the "Good Manufacturing Practice for Medical Devices (Trial)", and the revised "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Good Manufacturing Practice") was considered and approved by the 17th Office of the Director of the State Food and Drug Administration on December 12, 2014, and was announced and released on December 29, 2015, and will come into force on March 1, 2015, accordingly.
The revised Code***thirteen chapters and eighty-four articles require medical device manufacturers to establish and improve the quality management system in accordance with the Code, and stipulates the organization and personnel, plant and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales, control of nonconforming products, adverse event monitoring, analysis and improvement, and other aspects of the content.
In order to do a good job in the full implementation of the Code, combined with the release of the Code, the State Food and Drug Administration will also be based on sterile, implantable medical devices, as well as customized prosthetics and other different categories of medical devices production of special requirements, the development of detailed specific provisions, while speeding up the medical device supervision and inspection team capacity building, improve the ability and level of supervisory personnel, for the Code The implementation of a good foundation to further enhance the quality assurance level of medical device manufacturers.