In order to implement the "Regulations on the Supervision and Administration of Medical Devices" and implement the "Opinions of the State Council on Reforming the Examination and Approval System for Drug Medical Devices" (Guo Fa [2015] No. 44), strengthen the supervision and management of clinical trials of medical devices, according to 2017 Key work arrangements, the Food and Drug Administration, in accordance with the principle of “double random and openâ€, organizes the clinical trial data authenticity and compliance supervision and inspection in the application for medical device registration, investigates and punishes clinical trial violations, and supervises The inspection situation and the results of the treatment are announced to the public. The relevant matters are hereby notified as follows:
First, the scope of inspection
The scope of clinical trial supervision and inspection is the clinical trial project carried out by the Food and Drug Administration in the application for registration before June 1, 2017, including the registration of all domestic third-class and imported medical devices to obtain clinical trial data through clinical trials in China. Application Project. The Food and Drug Administration will take into account the factors such as the degree of product risk, complaints and reports, etc., and will issue a notice to the clinical trial project for spot checks.
Second, the basis for inspection
This supervision and inspection is based on the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Registration of Medical Devices (Order No. 4 of the Food and Drug Administration), the Measures for the Administration of Registration of In Vitro Diagnostic Reagents (Order No. 5 of the Food and Drug Administration), Medical Device Clinical Trial Quality Management Regulations (Organization of Food and Drug Administration Order No. 25), "In vitro Diagnostic Reagent Clinical Trials (Research) Technical Guidelines" and "Medical Device Clinical Trial Site Inspection Points" (General Notice of Food and Drug Administration 2016) Annex 98, No. 98).
Third, the inspection procedures
The Food and Drug Administration will form an inspection team in late July 2017, and conduct on-site inspections in accordance with the “On-site inspection procedures for clinical trials of medical devices†(Annex 2 of the Food and Drug Administration Notice No. 98 of 2016). Before the implementation of the on-site inspection, the corresponding clinical trial institutions, registered applicants (agents), and the provincial food and drug administrations where the clinical trial institutions and registered applicants (agents) are located will be notified in writing. The provincial food and drug administrations at the locality of the clinical trial institutions and registered applicants (agents) are each assigned an observer to participate in on-site inspections and coordinate on-site inspections.
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