Notice on Organizing the Work of Launching the Innovation Task of Biomedical Materials

Date of issue:

2022-12-25

Views:

All provinces, autonomous regions, municipalities directly under the Central Government and cities specifically designated in the state plan, the competent departments of industry and information technology of Xinjiang Production and Construction Corps, the drug supervision and administration departments, relevant central enterprises, and relevant industry associations:

Biomedical materials, including polymer materials, metal materials, inorganic non-metallic materials, are indispensable new materials for the production of medical devices needed for diagnosis, treatment, repair and replacement of human tissues and organs or for the enhancement of their functions, which are of great significance to the protection of people's health. In order to speed up the development, production and application of biomedical materials in China, promote the collaborative innovation of biomedical materials upstream and downstream, and better support the high-quality development of the medical device industry, the Ministry of Industry and Information Technology and the State Food and Drug Administration jointly carried out the work of unveiling the innovation task of biomedical materials. Relevant matters are notified as follows.

1、 Task content and expected objectives

The unveiling and commanding work of biomedical material innovation task focused on three major directions of polymer materials, metal materials, and inorganic non-metallic materials, solicited and selected a group of units with key core technologies and strong innovation capabilities to focus on tackling key problems, and focused on breaking through a batch of large, comprehensive, advanced technology, strong driving force, and safe and reliable landmark biomedical materials, with material properties meeting the requirements of clinical application To form a stable and reliable large-scale production capacity and accelerate the implementation and application in relevant downstream medical device products.

（1） Polymer materials

Polymeric materials used in artificial blood vessels, covered stents, artificial joints, interbody fusion cages, absorbable sutures, balloon catheters, blood dialyzers, extracorporeal membrane oxygenators and other medical device products, including but not limited to polyurethane, poly (L-lactide caprolactone) (PLCL), medical polyetheretherketone (PEEK), medical polylactic acid derivatives (PLA/PLGA), medical polyoxycyclohexanone (PDO), ultra-fine polyethylene fiber shielding materials Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), non-phthalene plasticizers, medical implanted silicone rubber, polyformaldehyde (POM), medical polysulfone (PSU), medical polyethersulfone (PES), ultra-high molecular weight polyethylene, cycloolefin polymer (COP/COC), nylon and its elastomers, polyglycolic acid (PGA), poly4-methyl-1-pentene (PMP), etc.

（2） Metallic materials

Metal materials used for cardiac pacemakers, cardiac valves, nerve stimulators, neurovascular guides, vascular stents, artificial joints, orthopedic implants and other medical device products, including but not limited to ultra-thin titanium and titanium alloy, ultra-thin titanium wire, nickel-titanium alloy pipe, ultra-thin nickel-titanium wire, platinum-tungsten/platinum-nickel/platinum-iridium alloy ultra-thin wire, nickel-cobalt-chromium-molybdenum alloy wire, ultra-thin platinum alloy pipe/ring, cobalt-chromium alloy pipe/bar/wire Degradable medical magnesium alloy material, tantalum powder for medical additive manufacturing, etc.

（3） Inorganic nonmetallic materials

Inorganic non-metallic materials used for biomimetic composite bone scaffolds, dentures, bone defect filling and repair materials and other medical equipment products, including but not limited to biphasic calcium phosphate (BCP) ceramics, denture glass-ceramics, zirconia composite alumina, bioglass for regeneration and repair and other inorganic non-metallic materials.

2、 Recommended conditions

（1） The main body of the declaration must be the upstream and downstream consortium formed by the material manufacturing enterprises and medical device manufacturing enterprises, and medical and health institutions, universities, scientific research institutes, and testing institutions are encouraged to participate in the joint participation, with one leading unit. The units participating in the consortium must be enterprises and institutions registered in the People's Republic of China with independent legal personality, and have strong technological innovation ability and industrial application ability.

（2） The competent departments of industry and information technology of all provinces, autonomous regions, municipalities directly under the Central Government and cities specifically designated in the state plan, together with the drug supervision and administration departments, as the recommendation units, give priority to recommend projects with advanced technical indicators, mature technical routes, complete promotion and application plans, reasonable budget, and strong comprehensive ability of the public disclosure team.

（3） Each unit shall not take the lead in applying for more than 3 projects, and those that have been listed in the relevant projects in the early stage shall not be repeated.

3、 Work requirements

（1） The declaration subject can pass the declaration system（ http://biomed.caict.ac.cn/ ）Apply and fill in the required materials after registration. The deadline for declaration is February 10, 2023.

（2） The recommendation unit shall log in to the system with its account and confirm the recommendation list before February 24, 2023.

（3） The recommending unit should attach great importance to the work of listing and commanding the innovative tasks of biomedical materials, fully mobilize the enthusiasm of key enterprises, specialized and new 'small giant' enterprises, individual champion enterprises, medical and health institutions, universities and scientific research institutions, relevant industrial alliances and industry associations to apply for the listing and commanding projects, and do a good job of recommendation in accordance with the principles of government guidance, enterprise voluntariness, openness and fairness, In combination with the regional industrial advantages and clinical resources, we will increase the support for key varieties and key enterprises of the 'list and command', give priority to the allocation of project land, energy, sewage and other indicator resources selected as the 'list and command', and introduce supporting policies to encourage the application and promotion.

（4） The Ministry of Industry and Information Technology and the State Food and Drug Administration entrust a third-party professional organization to organize the selection and publication of the list of shortlisted companies, establish a 'horse racing mechanism', select the best of each listed product to launch the launch team (in principle, no more than 3) to tackle the key problems, and plan to incorporate the launch leader into the existing policy support channels, and provide investment and financing docking services relying on the national industrial and financial cooperation platform, And give priority to providing technical advisory services related to the review.

（5） After completing the task of tackling key problems (in principle, within 3 years from the date of the list being published), the Ministry of Industry and Information Technology and the State Food and Drug Administration entrust professional institutions to carry out the evaluation work and determine the winner of the list by selecting the best (in principle, no more than 2 products are listed). It is encouraged to register the relevant materials that have completed the listing task in the form of the medical device master file, and increase the application promotion support through policies such as insurance compensation for the first batch of application of new materials.

（6） The China Academy of Information and Communication, the Medical Device Technical Evaluation Center of the State Food and Drug Administration and the China Medical Device Industry Association provide process management, platform construction, evaluation organization, coordination services and other support work for the listing and commanding work.

Contact person and telephone number:

Department of Raw Materials Industry, Ministry of Industry and Information Technology

Wang Chenglong 010-68205568

Liu Bomin 010-68205564

Department of Consumer Products Industry, Ministry of Industry and Information Technology

Fu Yinan 010-68205638

Medical Device Registration Administration Department of the State Drug Administration

Hu Xueyan 010-88330635

Work consultation:

China Academy of Information and Communication

Li Man 010-62302915

Prince Letter 010-62305979