Recently, the State Drug Administration issued the emergency approval procedure for medical devices (hereinafter referred to as the procedure) to strengthen the emergency approval management of medical devices. The procedure shall go into effect as of the date of promulgation. The newly revised procedure is revised based on the emergency approval procedure for medical devices issued in August 2009. It aims to effectively prevent, timely control and eliminate the hazards of public health emergencies and ensure that the approval of medical devices required for public health emergencies is completed as soon as possible. The procedure specifies that "this procedure is applicable to the domestic class III and imported class II and class III medical devices confirmed by the State Food and drug administration, which are required for emergency response to public health emergencies, and there is no similar product on the market in China, or although similar products have been on the market in China, but the product supply can not meet the needs for emergency response to public health emergencies". At the same time, the procedure also clearly stipulates the emergency approval responsibilities of the drug administration of provinces, autonomous regions and municipalities directly under the central government. Previously, if the applicant intends to apply for emergency approval of medical devices, the applicant shall inform the corresponding food and Drug Administration Department of the information required for product emergency and product R & D in advance. The procedure specifies that for the application for emergency approval of medical devices, the domestic registration applicant shall inform the drug administration of the corresponding province, autonomous region and municipality directly under the central government of the information required for product emergency and product R & D. the drug administration of the province, autonomous region and municipality directly under the central government shall timely understand the development of relevant medical devices and take early intervention if necessary, Evaluate the products to be declared, and timely guide the registration applicant to carry out relevant declaration work. The procedure also adds requirements for the time limit of emergency approval. According to the requirements of the procedure, for medical devices confirmed by the State Food and Drug Administration for emergency approval (hereinafter referred to as "emergency approved medical devices"), if the medical device inspection institution of the drug regulatory department is entrusted to carry out the inspection, the relevant medical device inspection institution shall organize the inspection of medical devices within 24 hours after receiving the samples and issue the inspection report in time. When the relevant inspection capacity is insufficient, the State Food and drug administration may designate a medical device inspection institution with inspection capacity to carry out inspection. Meanwhile, for emergency approved medical devices, the corresponding drug administrations of provinces, autonomous regions and municipalities directly under the central government shall organize the verification of the quality management system within 2 days after receiving the notice from the State Food and drug administration, issue the verification report of the quality management system in time and submit it to the medical device technical evaluation center of the State Food and drug administration. The drug administrations of provinces, autonomous regions and municipalities directly under the central government may formulate emergency approval procedures within their jurisdiction with reference to these procedures for the emergency approval of class II medical devices within their jurisdiction, and report the relevant procedures to the State Drug Administration. It is worth noting that the procedure also points out that this procedure is not applicable to products urgently used in accordance with the regulations on the supervision and administration of medical devices. That is, "in the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent department of health under the State Council shall put forward suggestions for the emergency use of medical devices according to the needs of preventing and controlling events, and can be used urgently within a certain range and time limit after being demonstrated and approved by the drug regulatory department under the State Council". In addition, the emergency approval product of the 2009 version of the medical device emergency approval procedure is "medical devices applying for emergency approval", while the procedure adds "medical devices required for emergency recommended in writing by the national emergency response working mechanism". If there is a declaration related to emergency approval, the State Food and Drug Administration will organize experts to evaluate whether the medical devices applied for emergency approval and the medical devices required for emergency recommended in writing by the national emergency response mechanism meet the procedural requirements, as well as the R & D maturity and production capacity of the applicant's products through meetings, letter review and written solicitation of opinions, Timely confirm whether the product is subject to emergency approval, and notify the applicant, corresponding technical institutions and corresponding drug administrations of provinces, autonomous regions and municipalities directly under the central government of the results. (outlook new era)