Recently, the Food and Drug Administration issued the notice of the first batch of medical device clinical trial supervision and spot check projects in 2016.
In order to strengthen the supervision and management of medical device clinical trials, according to the "Notice on Conducting Medical Device Clinical Trial Supervision and Spot Checking Work" (State Food and Drug Administration Announcement No. 98 of 2016), the scope of the spot check and related principles, national food and drug The General Administration of Supervision and Administration has extracted 10 registration applications including the hepatitis E virus IgM/IgG antibody detection kit (colloidal gold method) (acceptance number: 15-1744), and will verify the authenticity and compliance of its clinical trial data. Implement a retrospective surveillance review. The acceptance number, product name, applicant and clinical test commitment unit of the specific registration application project are attached. The clinical testing institutions for specific inspection schedules and spot checks shall be notified separately by the Food and Drug Inspection and Inspection Center of the State Food and Drug Administration.
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