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2021100，，“”，，202131，《》（202114），202131，A，。
、
“”，，、，，2018628“”，“”，100，“”，“，”，，，，。
2.
3.
(1) Evaluation standards for annual quality credit A medical device manufacturers
In accordance with the "Opinions on the Classification and Supervision of Quality Credit for Medical Device Manufacturers in Guangdong Province (Revised in 2011)" (Guangdong Food and Drug Administration [2011] No.
(2) Circumstances exempted from verification of the registered quality management system
The following conditions should be met:
1.
2.
3.
(3) Documents to be submitted for exemption from verification of the registered quality management system
1.
2.
(4) The path for submission of materials exempted from the verification of the registered quality management system
1.
2.
(5) Circumstances where only authenticity verification is carried out
The following conditions should be met:
1.
2.
(6) Appendix to the same production quality management specification
For the product applied for registration this time, the applicable appendix of the medical device production quality management specification is consistent with the appendix applicable to the product that has passed the inspection.
(7) Only the authenticity verification report path
According to the existing medical device registration quality management system verification and declaration path, the application for deduction and exemption registration system verification will be explained, and only the authenticity verification of samples will be explained, and the following will be provided:
1.
2.
(8) The conclusion of verification of authenticity only
In the medical device registration quality management system verification result notice, the verification conclusion is consistent with the "Notice" regarding the exemption of medical device registration quality management system verification, and the sample authenticity verification conclusion should be clear whether it is passed.
references
[1]mpa.
gd.
gov.
cn
