About the requirements: site, personnel, mature production processes, more molded quality management system.
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 devices products for quality inspection of the organization or personnel and inspection equipment.
The process is mainly: ready for the above conditions, in accordance with the requirements of the Food and Drug Administration to organize the materials reported to the Shanghai Pharmaceutical Administration, acceptance of the review of your materials, a period of time will come to you after the on-site inspection, ok then over, a few days after the issuance of certificates. Of course, the various stages of which will not be so smooth, if it is a sterile product more trouble.
The process is not clear in a few words, because there are many variables.