Quality Management System For Medical Devices Guidance On The Preparation Of Annual Self-Inspection Reports (Draft For Comments)


According to the provisions of the Regulations for the Supervision and Administration of Medical Devices, medical device registrants, filers and entrusted manufacturers shall, in accordance with the requirements of the Code of Practice for the Quality Management of Medical Device Production and the relevant appendices, carry out annual self-inspection of the quality management system of medical device production, prepare and report the annual self-inspection report of the quality management system, which shall include at least the following contents.