01
Encourage the innovative development of high-end devices, including these categories
The Catalogue (2024 Edition) consists of three categories of catalogues: encouraged, restricted and eliminated.
It shows that in the field of medicine, the innovative development of high-end medical devices is encouraged.
Specifically, it includes: new gene, protein and cell diagnostic equipment, new medical diagnostic equipment and reagents, high-performance medical imaging equipment, high-end radiotherapy equipment, life support equipment for acute and critical illnesses, artificial intelligence-assisted medical equipment, mobile and remote diagnostic and therapeutic equipment, high-end rehabilitation aids, high-end implantable and interventional products, surgical robots, and other high-end surgical equipment and consumables, biomedical materials, additive manufacturing technology development and application. technology development and application.
In addition, intelligent medical treatment, medical image auxiliary diagnostic system, medical robot, wearable devices, etc. are also included in the encouraged catalogue.
Medicine in the restricted category, the medical devices involved include: new construction, expansion of mercury-filled glass thermometers, sphygmomanometers, silver-mercury 94 amalgam dental materials, new 200 million / year below the production of disposable syringes, blood transfusion, infusion device production units.
The pharmaceutical phase-out category includes: mercury-filled glass thermometers, sphygmomanometer production units (31 December 2025), etc.
The above document also pointed out that the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government should take into account the actual development of industries in their respective regions, formulate specific measures to reasonably guide the direction of investment, encourage and support the development of advanced production capacity, restrict and eliminate backward production capacity in accordance with the law, prevent blind investment and low-level repetitive construction, and effectively promote the optimisation and upgrading of industrial structure.
02
Support for the promotion and application of domestically produced medical equipment
China’s medical device industry is in a booming stage. Data show that in 2022, China’s medical device main business income has reached 1.3 trillion yuan, China’s medical device industry in the past five years the average annual compound growth rate of 10.54%.
National level, long-term support for the development of medical device industry.
The “14th Five-Year Plan” for the development of medical equipment industry puts forward, focusing on the development of diagnostic and testing equipment, therapeutic equipment, guardianship and life support equipment, Chinese medicine diagnostic and therapeutic equipment, maternal and child health equipment, health care and rehabilitation equipment, active implantation of interventional devices in the field of the 7 major devices.
By 2025, the level of technology will continue to improve. Medical equipment in the field of prevention, diagnosis, treatment, rehabilitation, health promotion, public health and other areas to achieve large-scale application. A number of high-end products such as extracorporeal membrane lung oxygenation machine (ECMO), luminal surgery robot, 7T human whole-body magnetic resonance imaging system, proton heavy ion integrated treatment system, etc. will be applied.
The promotion and application of domestically produced medical devices has also been given priority attention.
In August this year, the State Council executive meeting considered and adopted the Action Plan for High-Quality Development of Medical Equipment Industry (2023-2025). The meeting stressed that we should attach great importance to the promotion and application of domestic medical equipment, improve relevant support policies, and promote the iterative upgrading of domestic medical equipment.
At the local level, many places have issued development programmes to encourage the development of the medical equipment industry, and have introduced supporting measures in the areas of assessment and evaluation, application in hospitals, and payment of medical insurance.
The General Office of the People’s Government of Guangdong Province issued the Notice of the Implementation Programme for Promoting High-Quality Development of Medical Device Industry in Guangdong Province. The development goal is to strive to 2025, the medical device manufacturing industry revenue compound annual growth rate of 20% or more, the size of the medical device manufacturing industry above the annual operating income of 250 billion yuan; approved by the national registration certificate of innovative medical devices to reach 50; cultivation of the capital market listed enterprises to reach 35, listed market value of more than 100 billion yuan demonstration of the enterprise 2-3, the annual operating income of more than 10 billion yuan of the leading enterprises 3-3 3-5 leading enterprises with annual business revenue of over 10 billion yuan and 5-8 leading enterprises with over 5 billion yuan; create a number of independent brand backbone enterprises with international influence, and form high-end medical device industry clusters benchmarked against the world’s first-class level.
The General Office of Jiangsu Provincial Government issued the Notice on Optimising Review and Approval Services to Promote the Use of Innovative Medicines and Devices and Promote the High-quality Development of the Pharmaceutical Industry (2022-2024), proposing to strengthen the support of clinical research, promote the re-engineering of the review and approval process, implement the priority review and approval, expand the resources for review and approval, unimpeded the channels for innovative medicines and consumables to be listed on the network, and promote the innovative medicines and consumables into hospitals and other twelve items. The Circular proposes to strengthen clinical research support, promote the reengineering of the review and approval process, implement priority approval, expand review and approval resources, smooth the channels for listing innovative drugs and consumables on the network, and promote innovative drugs and consumables into hospitals.
The General Office of the People’s Government of Sichuan Province issued the Notice on a Number of Policy Measures to Support the High-Quality Development of Medical and Healthcare Equipment Industry, proposing thirteen policy measures such as strengthening core technology research, supporting increased investment in R&D, optimising review and approval services, strengthening the promotion and use of products, and increasing financial support.
On the whole, China’s medical device industry has entered a new stage of “running with, running alongside and leading”, and a number of domestic leading enterprises have emerged one after another to compete with multinational giants in various sub-tracks. At the same time, in terms of breaking through key core technologies, striving for high-end market and strengthening source innovation, there is still room for further opening up the situation.
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Post time: Jan-04-2024