Help medical device approval 15 provinces to simplify the registration process

How can the country's innovative medical devices be released to the maximum extent? In order to implement the Opinions of the State Council on Reforming the System of Review and Approval of Pharmaceutical Medical Devices, the provincial bureaus of Beijing, Liaoning, Shanghai, Zhejiang, Hunan and Guangdong have issued priority approval measures for innovative medical devices, optimizing and simplifying the registration process for the second category of medical devices. At present, 15 provinces have implemented the medical device registration fee system, and provinces that have not yet implemented the registration fee are coordinating the relevant local departments and actively promoting related work.
statistics show that by the end of 2016, CFDA had received 488 applications for special approval for innovative medical devices, completed 461 reviews, and 89 products had entered the special approval channel for innovative medical devices. Approved orthopaedic surgical navigation and positioning system, cold salt water radio frequency perfusion ablation catheter and other 20 products on the market. Among them, the world's first approved pulmonary artery valve pipe to fill the gap in the field of high-end artificial biological heart valves of domestic medical devices.
In addition, on the basis of further scientific and reasonable clinical evaluation requirements for medical devices, and on the premise of ensuring safety and effectiveness, the General Administration also issued a second batch of medical devices exempt from clinical trials, 267 types of second-class medical devices, 92 types of third-class medical devices, a total of 359 medical device products exempt from clinical trials. Among them, there are 15 kinds of in-body diagnostic reagent products, which is also the first time that in-body diagnostic reagent products have been included in the list of exempt from clinical trials.
pointed out that over the past year, the reform of the medical device review and approval system has been comprehensively promoted. In accordance with the State Council's Opinions on Reforming the System of Review and Approval of Pharmaceutical Medical Devices, we will actively take effective measures to make up for the short boards. In view of the problems such as the low quality of registration application data, strengthen the formulation of technical examination guidelines, further refine the provisions and clear requirements, speed up the reform of the personnel system of technical review institutions, recruit non-staff personnel to enrich their strength, and explore the use of expert resources, the use of "external brain" as a regulatory service; Establish a committee of review experts to conduct joint review by the panel, and in response to the lack of innovation momentum in the medical device industry, the Special Approval Procedure for Innovative Medical Devices, the Priority Approval Procedure for Medical Devices, has been issued to encourage medical device innovation to further meet the clinical use needs of medical devices; We will promote the improvement of the overall level of the industry, strengthen the verification of the quality system of overseas production and prevent and control the risk of imported medical devices in view of the lack of on-site verification of imported medical devices.
, "Medical device review and approval is the first pass of listed product quality, is a key link in the supervision and management of medical devices." It is of great significance to promote the reform of the review and approval system and improve the quality and efficiency of the review and approval, so as to improve the quality of medical device products and promote the reform of the supply-side structure."
stressed that we should continue to promote the reform of classification management, establish a dynamic adjustment mechanism for classification catalogues, and evaluate medical device risks in a timely manner. We will steadily promote basic work on medical device standards, naming and coding, improve the standard management system for medical devices, and strengthen the research and transformation of international standards. We will deepen reform and promote the implementation of the government's policy of purchasing services. The General Administration shall continue to strengthen the guidance on capacity-building for the examination and approval of medical devices at the provincial level, conduct a comprehensive assessment, and, if the technical review capacity is not up to the requirements, the General Administration shall study and introduce corresponding measures. (3156 Pharmaceutical Network)