State Food and Drug Administration: support the development of such devices!

Source: State Food and Drug Administration ▍ finishing: Cypress blue instrument Recently, according to the official website of the State Food and drug administration, a reply was made to the proposal made by the representative of the National People's Congress, saying that he would vigorously support the development of innovative medical devices The State Drug Administration attaches great importance to encouraging the innovation and development of medical devices In 2014, the former food and Drug Administration issued the special examination and approval procedures for innovative medical devices (Trial), and in 2018, the State Drug Administration revised and issued the special examination procedures for innovative medical devices This procedure has set up a special examination and approval channel for medical devices with Chinese invention patents, domestic initiative in technology, international leading level, and significant clinical application value For the innovative medical devices approved according to this procedure after examination, the pharmaceutical supervision and administration department and relevant technical institutions shall give priority to the innovative medical devices according to the principle of early intervention, special person in charge and scientific approval, and strengthen the communication with the applicant The implementation of this procedure plays a positive role in encouraging the research and innovation of medical devices, promoting the promotion and application of new technologies of medical devices, and promoting the development of medical device industry In 2016, the former food and Drug Administration issued the priority approval procedure for medical devices, which gave priority to the approval of medical devices included in the major national science and technology projects or key research and development plans, diagnosis or treatment of rare diseases, malignant tumors, special and multiple diseases of the elderly, medical devices for children, and medical devices urgently needed in clinical, so as to promote the listing of such products as soon as possible 。 At present, the government of Guangdong Province is studying the construction ideas of relevant technical support institutions for drug and medical device evaluation and inspection in Guangdong Hong Kong Macao Bay area, actively supporting the innovation of system and mechanism conducive to medical device supervision, and promoting the innovation and development of medical device industry in Guangdong Hong Kong Macao area After the establishment of the medical security bureau, the preparation of medical service price is divided into two steps: First, we need to find out the situation of medical charges in all provinces and update the general catalogue of medical charges On this basis, each province will formulate the corresponding catalogue of medical charges according to its actual situation; Second, accelerate the access to new technology and related pricing work, so as to form a unified market Each province appropriately selects new projects approved by the state according to the technical capacity, so as to reduce the burden of medical device enterprises and promote the promotion of innovative medical devices in the market Before the completion of the above work, the provinces shall still implement the current system, and the province shall formulate the charging catalogue and charging standards of relevant medical service projects After the establishment of the medical security bureau, it is responsible for the formulation of bidding and purchasing policies for drugs and medical consumables For new products approved for marketing, including innovative medical devices, relevant policies will be introduced from the following two aspects: First, refine the provincial centralized bidding procurement platform filing procurement system for medical devices, and limit the filing cycle; The second is to form a national price linkage mechanism for medical devices, gradually realize "one province linked to the Internet, the whole country can be adopted", minimize the cost of enterprise bidding and sales, and remove obstacles for the successful marketing of innovative medical devices About medical device medical insurance catalogue The original Ministry of labor and social security and other ministries and commissions issued the notice on printing and distributing opinions on management, scope of medical service facilities and payment standards of basic medical insurance for urban employees (LSBF [1999] No 22), which defined the scope of national basic medical insurance diagnosis and treatment projects, and stipulated various medical technical labor projects and procurement of medical insurance not paying fees and paying part of fees Diagnosis and treatment projects with medical instruments, equipment and materials On this basis, according to the actual situation of medical technology development and basic operation, provinces determine the scope of basic medical insurance diagnosis and treatment projects by exclusion or access method.