Article 19 of the medical device manufacturer shall meet the following conditions:
(a) with its production of medical devices appropriate professional and technical personnel;
(b) with its production of medical devices compatible with the production site and the environment;
(c) with its production of medical devices compatible with the production equipment;
(D) has its production of medical equipment products for quality inspection of the organization or personnel and inspection equipment.
Accept the on-site inspection by the Drug Administration, and issue the license after passing