Recently, the State Food and Drug Administration issued the "Notice on Conducting Medical Device Clinical Trial Supervision and Spot Checking Work", and decided to carry out the authenticity and compliance of clinical trial data carried out before June 1, 2016 in the application for medical device registration. Supervised inspection; a retrospective examination was conducted to conduct a random inspection of all domestic third-class and imported medical devices in China through clinical trials to obtain clinical trial data for registration applications.

The Circular clarifies that if the clinical trial data submitted by the registration application is inconsistent with the corresponding clinical trial data kept by the clinical trial institution, the clinical trial data cannot be traced, and the test product/test in vitro diagnostic reagent or the test sample is not true. It is judged that there is a problem of authenticity; if the authenticity problem is not found, but the clinical trial process does not meet the requirements of the medical device, it is determined that there is a compliance problem. If there is a problem of authenticity, it will be handled in accordance with relevant laws and regulations, and the corresponding medical device registration application will not be registered.

Medical device clinical trial supervision and spot check work notice

The State Food and Drug Administration said that if a registered applicant believes that the clinical trial data of his registration application has authenticity and serious compliance problems, he may apply for withdrawal by himself; after issuing a random clinical trial project notice, the bureau will no longer accept the relevant registration application. The person withdraws by himself.

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