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In order to standardize the filing of clinical trials of medical devices and strengthen the supervision and management of clinical trials of medical devices, the General Administration of Food and Drug Administration issued the Announcement on matters related to the filing of clinical trials of medical devices (hereinafter referred to as the Bulletin).
the Announcement, the bidders shall submit relevant materials for clinical trials of medical devices, file a record with the provincial food and drug regulatory department in the locality, and import medical devices with the provincial food and drug supervision and administration department where the agent is located.
The Proclamation states that if the filing materials are complete and meet the requirements, the provincial food and drug supervision and administration department shall file the record on the spot and inform the same level of food and drug supervision and administration department and the competent department of health and family planning where the clinical trial institution is located.
the Announcement, the Food and Drug Administration should strengthen supervision and inspection of the filing of clinical trials of medical devices and investigate and punish violations of regulations in accordance with the law. (National Food and Drug Administration)