Recently the CFDA has a new interpretation:
A, on the clinical trial of medical devices with a one-year validity of the registration inspection report
"Clinical trials of medical devices quality management norms," Article VII states: "quality inspection results include self-inspection reports and qualified inspection agency issued within one year of the product registration test Qualified report". For which the inspection agency within one year of the product registration inspection report, in the case of multi-center clinical trials, is to test the time of the report to the lead unit of the clinical trial ethical review of the time to calculate the one-year period of validity; in the case of non-multi-center clinical trials, is to test the time of the report to the time of the ethical review of the time of the adoption of each clinical trial organization to calculate the time of one-year period of validity, respectively.