Medical device production license process is: the applicant submits the application information to the relevant departments; the relevant departments to accept the applicant's application; to the actual site for investigation and review of the product; the relevant departments to grant the issue of medical device license.
Legal Objective:"Supervision and Management of Medical Device Manufacturing Measures" Article 7 engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment, and professional and technical personnel; (b) there is the production of medical devices for the production of quality inspection organizations or full-time inspectors and inspection equipment; (c) there is a guarantee of medical device quality. (C) have to ensure that the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capacity; (E) in line with the product development, production process documentation requirements.