Hello, on the question of how to fill in the annual self-inspection report on the quality management standard for class III medical device business enterprises in Ningde City, I have found the relevant regulations in Ningde Food and Drug Administration. The complete regulations and templates are shown in the attachment. The following is the relevant regulations. I hope it will be helpful to you.
One, in order to further implement the main responsibility of medical device business enterprises, effectively strengthen the internal quality management, strict implementation of medical device regulatory regulations and norms, to ensure that the quality and safety of medical device products, based on the "quality management standard for the operation of medical devices", the development of this self-inspection report. Enterprises should be regularly in accordance with the requirements of this report each year to carry out self-inspection of the whole project, and fill in each item.
Second, the medical device business quality management standard self-inspection project *** 83, of which the key inspection items (articles before the addition of "※") 29, 54 general inspection items.
Three, the enterprise can be based on the scope of medical device products, requirements, to determine the appropriate inspection terms and content. Not applicable to the provisions of the "should indicate" the "reasons for not applying.
Four, the results of self-inspection to fill in the requirements to describe the verifiable facts. For only fill in the "yes" "in line with", can be returned as incomplete information to supplement.
V. Enterprises are committed to the authenticity of the self-inspection, and are willing to bear any legal consequences arising from inaccuracies.