Interpretation of Quality Problems in Medical Device of Clinical Trials

1. One year validitytest report of medical device registration on clinical trial

“Specification for quality management of medical deviceson clinical trials," Article VII: "quality inspection reports includeself-inspection report and a qualified inspection agency issued within one year of product registration inspection report." One-year validity of multi-center clinical trialsrefers tothe time from inspection report issued ofleading clinical trial agency to ethical review passed.In Another caseone-year validity of non-multi-center clinical trials,from inspection report issued to each clinical trial agency ethical review passed, will be countedindividually.

2.Clinical filing of medical equipment

In accordance with the requirements of Article 1 of the “Notice on the Matters Relating to the Clinical Trial of Medical Devices” (No. 87 of 2015), each sponsor can make Clinical filingto his local provincial food and drug administration,after making an agreement or contract with each clinical trial institution,whenfinishedhe can start clinicaltrials. If the same clinical trial project is filed more than once, the sponsor should provide all the filing forms that have been obtained at this time. To be unified and checkable,record numberfor same project of clinical filing should be marked by Provincial food and drug administration.

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