On December 29, 2023, China’s National Development and Reform Commission (NDRC) released the “Guidance Catalog for Industrial Structural Adjustment (2024 Edition)”. The new version of the catalog will come into effect on February 1, 2024, and the “Guidance Catalog for Industrial Structural Adjustment (2019 Edition)” will be abolished at the same time. The “Catalogue (2024 version)” consists of three categories: encouragement, restriction and elimination.
The “Catalog (2024 Edition)” shows that in the field of medicine, innovative development of high-end medical devices is encouraged, which includes new gene, protein and cell diagnostic equipment, new medical diagnostic equipment and reagents, high-performance medical imaging equipment, high-end radiotherapy equipment, critical and critical life support equipment, artificial intelligence-assisted medical equipment, mobile and remote diagnosis and treatment equipment, high-end rehabilitation assistive devices, high-end implantable interventional products, surgical robots and other high-end surgical equipment and consumables, biomedical materials, and additive manufacturing technology development and application.
In addition, smart medical care, medical image-assisted diagnosis systems, medical robots, wearable devices, etc. are also included in the encouraged category.
China’s medical device industry is in a stage of vigorous development. At the national level, we have long-term support for the development of the medical device industry.
The “14th Five-Year Plan Medical Equipment Industry Development Plan” proposes to focus on the development of seven major device fields: diagnostic testing equipment, treatment equipment, monitoring and life support equipment, traditional Chinese medicine diagnosis and treatment equipment, maternal and child health equipment, health care rehabilitation equipment, and active implant interventional equipment. By 2025, the technological level will continue to improve. Medical equipment has been applied on a large scale in the fields of prevention, diagnosis, treatment, rehabilitation, health promotion, and public health. A number of high-end products such as extracorporeal membrane oxygenation machine (ECMO), laparoscopic surgery robot, 7T human whole body magnetic resonance imaging system, and proton and heavy ion integrated therapy system have been implemented.
In the pharmaceutical restricted category, the medical devices involved include: new construction, renovation and expansion of mercury-filled glass thermometers, sphygmomanometer production equipment, amalgam 94 dental materials, new disposable syringes and blood transfusions with a value of less than 200 million pieces per year , infusion set production equipment.
The pharmaceutical phase-out category includes: mercury-filled glass thermometers, sphygmomanometer production equipment (December 31, 2025), etc.
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