The conditions required for a medical device manufacturing license are:
(1) hold the enterprise's "Medical Device Registration Certificate";
(2) have with the production of medical devices suitable production sites, environmental conditions, production equipment, and technical personnel;
(3) have to the production of medical devices for the quality of the test Institutions or full-time inspectors and inspection equipment;
(4) have a management system to ensure the quality of medical devices;
(5) with the production of medical devices compatible with the after-sales service capabilities;
(6) in line with the requirements of product development, production process documentation.
Legal objective:"Supervision and Administration of Medical Device Business" Article 3
Engaged in medical device business activities, shall comply with the laws, regulations, rules, mandatory standards and quality management standards for medical device business and other requirements to ensure that the medical device business process information is true, accurate, complete and traceable. Medical device registrants, filers can sell their own, but also can be entrusted to the medical device business enterprise sales of its registration, filing of medical devices.