Source: China Medical Journal
In order to optimize the medical review and approval process, improve the efficiency of review and approval, issued the "decision of the State Food and Drug Administration concerning the adjustment of the medical administrative examination and approval procedures for the examination and approval of the State Food and Drug Administration (" the day before the State Food and Drug Administration Decree No. thirty-second) (hereinafter referred to as the "decision"), for examination and approval clinical trials, the administration is responsible for re registration and renewal of registration approval, registration approval and other medical equipment administrative approval and approval procedures to be adjusted.
According to the "decision", from July 1, 2017 onwards, third types of high risk medical device clinical trial approval decision, made third types of medical equipment and medical equipment import licensing matters change approval decision, made third types of medical equipment and medical equipment import registration renewal approval decision, made by the administration of Medical Devices Evaluation center on the administration of the name.
The administration pointed out that in 2014, General Administration to actively implement the new revision of the "supervision and administration of medical devices regulations", issued a "medical device registration" and "in vitro diagnostic reagent registration", "third kinds of domestic and import medical device registration approval operation specification" and other documents, the 4 links clearly within the class third and imported medical device registration approval including acceptance, technical review, administrative examination and approval of production. The technical review shall be handled by the General Administration of medical equipment technical review center, and the administrative examination and approval shall be in the charge of the general administration. After the technical review of medical instruments has been completed, the General Administration shall, within 20 working days from the date of receipt of the technical review opinions, make the examination and approval decision. This will be part of the examination and approval of the technical evaluation and administrative examination and approval decisions are made by the administration of Medical Devices Evaluation Center for approval after the adjustment procedures include acceptance, technical evaluation and administrative examination and approval, approval of 3 links, optimize the approval process. For approval after adjustment, administration of Medical Devices Evaluation Center approval decision made after the administration of relevant departments in 10 working days to produce the "medical device registration certificate", "medical registration documents", "non administrative licensing decision" and other documents.
The Administration said on the part of medical administrative examination and approval procedures for the examination and approval of the adjustment of administration is an important measure to implement the spirit of reform of medical review and approval system, the integration of technology evaluation and administrative examination and approval of resources, optimize work flow, will further improve the working efficiency.