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just! National Food and Drug Administration, Ministry of Science and Technology, Intellectual Property Office hit a combination of boxing, domestic medical equipment to the cattle!

发布时间:2018-01-31

       Domestic medical devices are ushering in a new opportunity for development!

       On January 30, the State Food and Drug Administration and the Ministry of Science and Technology jointly issued the Guidance Opinions of the Ministry of Science and Technology of the Food and Drug Administration on Strengthening and Promoting the Scientific and Technological Innovation of Food and Drugs (hereinafter referred to as the Guiding Opinions).

       We must explicitly target the development of food and pharmaceuticals, the development of medical device technology and the growing health needs of the people. We have systematically deployed regulatory and scientific research and development bases, innovation bases, service industry clusters and the establishment of a collaborative mechanism of production, education and research. To lead and support food safety and innovation in the development of pharmaceutical and medical device industries, boost the supply-side structural reform and development quality of pharmaceutical and medical device industries, and promote the research, development and upgrading of food, drug and medical devices.

       On January 23, SIPO released the Notice on Printing and Distributing Catalog of Key Industries Supported by Intellectual Property (Version 2018), which clearly identified the top ten industries to be supported by the state in 2018. Among the top ten branches of the health industry, In medical equipment, a total of 6 categories of medical equipment will be key support!



       January 9, the national science and technology work conference held in Beijing. Ministry of Science and Technology Wan Gang named, in 2018, Ministry of Science and Technology will accelerate the localization of medical equipment, high-end, brand, international.

       Since January, the first national science and technology minister named to support the domestic medical equipment, and then the State Intellectual Property Office to support the domestic 6 categories of medical equipment heavy files released, followed by the State Food and Drug Administration, Ministry of Science and jointly issued a joint announcement to focus on supporting domestic medical Equipment innovation!

       The signal released is too strong: In the critical period of national economic restructuring, the medical device industry appears to be the key area for the real economy, and it is the key support for development!

       The purpose of medical reform is not only to cut prices, not to suppress pharmaceutical companies, it is necessary to improve the supply side, so that more and better drug products to speed up the market, so that a group of good pharmacy enterprises stand out to the healthy development of the pharmaceutical industry Road.

       Under this formulation, with the continuous deepening of medical reform and the future, domestic high-performance medical devices are likely to usher in more supportive policies and truly become the "sunrise industry" of the economy.

       In the Guiding Opinions, in encouraging innovation in home-made medical devices, the State Food and Drug Administration and the Ministry of Science and Technology 4 are pushing forward and pushing forward!

       details as follows:

       First, optimize the layout of scientific and technological innovation

       1. Strive to enhance the scientific and technological innovation support capability in the field of food, medicine and medical equipment. Relying on the relevant national science and technology plans (special funds, funds, etc.), we will increase support for the key medicines, innovative drugs and advanced medical devices, which are in urgent need of the masses. Focus on support for clinical needs and rare diseases treatment of medical devices research and development, and after the listing of drug medical device monitoring and re-evaluation, around the industrial chain deployment of innovation chain, improve the capital chain around the innovation chain, co-ordinate the promotion of medical device product development, manufacturing, clinical application Results of the whole chain of innovation.

       2. Establish and improve scientific research support network. Strengthen the integration of social resources in the fields of food, medicine and medical device innovation and establish a multi-sectoral and multidisciplinary joint innovation network. Select a group of basic technical conditions, research enthusiasm for food and drug regulatory technical support institutions and universities, research institutes and enterprises to establish a research center.

       Second, build a high level of scientific and technological innovation base

       1. Actively promote the construction of key laboratories. Focus on the food safety, the innovation chain of medical devices and regulatory requirements, organize relevant units of the food and drug regulatory system to participate in the construction of national laboratories and national key laboratories in the field of health such as food and medicine, strengthen leading original research, research and development of common technology and core technologies Tackle key scientific and technological issues in food and drug and medical device innovation.

       2. Strengthen the construction of major technological innovation platform. Optimize the allocation of resources for scientific and technological innovation, take the form of industry-university-academia combination and technological innovation alliance, and select superior units in terms of talents, disciplines and resources according to the principle of co-construction and sharing, and focus on the strategic needs for building a healthy China's construction and medical system reform, Nurture a group of innovative medicines and innovative medical equipment, food safety and other major technological innovation platform.

       3. Cooperate to promote the construction of National Clinical Research Center. For the major clinical needs and industrialization needs, the National Clinical Research Center to actively carry out clinical research, academic exchanges, personnel training, the achievement of transformation and promotion of applications and so on. The clinical research center to carry out clinical trials of medical devices into the evaluation assessment and management priorities, including clinical trial conditions, clinical trial organization and management, researchers, equipment and facilities, management systems, operating procedures and so on.

       4. Strengthen provincial science and technology innovation base construction. Provincial food and drug regulatory authorities and provincial science and technology administrative departments should focus on the top-level design of food and drug and medical device industries in the province and prioritize the construction of a number of key provincial-level key laboratories with outstanding features and distinctive features. Engineering research center and technological innovation center and other research and innovation base, to carry out forward-looking, basic and applied technology research and development.

       Third, to create a scientific research innovation atmosphere

       Promote the transformation of scientific and technological achievements. The food and drug regulatory authorities shall fully implement the relevant provisions and documentary motivation of the State in promoting the transformation of scientific and technological achievements, establish and improve the policy support for medical devices for innovative medicines, and all review agencies shall step up early intervention and follow-up services and start early registration with applicants "Research and trial linkage" to accelerate innovation and medical equipment research and development and transformation. The establishment of nonprofit scientific and technological achievements into evaluation and incentive mechanisms to guide the scientific and technological achievements of personnel in accordance with the relevant provisions of the state to carry out innovation and entrepreneurship. Support qualified units to carry out scientific and technological achievements into standard pilot work to promote more application of scientific and technological achievements into technical standards.

       Fourth, implement innovative medical equipment special fund support

       Scientific and technological administrative departments at all levels should pay attention to and strengthen scientific research in the fields of food, medicine and medical devices and make overall plans and arrangements in related science and technology plans (special funds and funds). National and provincial food and drug regulatory authorities should make full use of their own advantages in resources, open up diversified channels for capital investment, and intensify scientific and technological innovation research on food, medicine and medical devices.

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