Unexpected public health emergencies may be required to fast-track Yi Xie
In the future, when there is a threat to public health emergencies or public health emergencies, pharmaceutical sector to the emergency disposal of medical equipment required for the implementation of emergency for approval. State Food and Drug Administration recently issued "emergency medical equipment approval procedures" to ensure public health emergency medical equipment needed to complete the examination and approval as soon as possible.
Emergency approval of medical devices is mainly applied to two situations: First, the necessary public health emergencies, but in our country there is no listing of similar products; Second, despite the availability of similar products in our country market, but the product supply can not meet the emergency processing requirements.
Emergency examination and approval procedures in accordance with the provisions of the State Food and Drug Administration will set up a special group of experts on the application for approval of emergency medical equipment to assess and review. Applications received, the first class of medical devices should be five days to complete the examination and approval, while the second type of medical equipment, medical devices should be the third category, respectively 8, 13 days to complete the examination and approval.
According to reports, medical device approval will be based on the contingency, "unity of command, early intervention, rapid and efficient, scientific examination and approval" principle, it is necessary to ensure the timely approval, rapid, and also to ensure quality and safety of medical devices. Examination and approval procedures in accordance with the provisions of the approval for the emergency medical device, pharmaceutical sector are expected to organize on-site assessment work, and inspection reports issued by the Quality Management System.