High-end devices are expected to accelerate the landing.
01
The promotion project of high-end medical equipment was launched
Five areas released positive signals
Recently, the General Office of the Ministry of Industry and Information Technology and the General Office of the National Health Commission issued the Notice of the General Office of the National Health Commission of the General Office of the Ministry of Industry and Information Technology on the application of high-end medical equipment promotion Project in 2024 (hereinafter referred to as the Notice).
"Notice" pointed out that for typical application scenarios, the selection of a number of high-end medical equipment technology innovation and clinical application level in the forefront of the country, high-end medical equipment medical industry
collaborative innovation, pilot validation, clinical research, iterative upgrading and promotion and application of the project has a strong leading role. This year focuses on the promotion and application of high-end medical equipment in five directions: diagnostic testing, treatment, monitoring and life support, elderly care rehabilitation, and artificial intelligence assisted diagnosis and treatment.
It involves magnetic resonance, CT, PET/CT, DSA, color ultrasound, automatic chemiluminescence immunoanalyzer, endoscopic surgery robot, orthopedic navigation robot, neurosurgical navigation robot, ECMO, cochlear implant and other categories.
Specific products are as follows:
According to the requirements of the documents, for the high-end medical equipment products declared for promotion and application, the leading medical equipment manufacturer must have obtained the medical device registration certificate of the People's Republic of China.
The medical industry consortium should establish a relatively complete medical equipment development and production, clinical research management and financial security system, medical institutions focus on ensuring the technical and environmental conditions for clinical application research and promotion of high-end medical equipment; Medical equipment manufacturers focus on ensuring the operation safety of high-end medical equipment and improving the technology and hardware and software conditions.
According to the Notice, the Ministry of Industry and Information Technology and the National Health Commission organized experts or third-party institutions to review the application materials for promotion projects, select and publish the list of promotion and application projects that meet the requirements. The implementation cycle of promotion and application projects generally does not exceed 3 years.
02
Stabilize and recover
The medical device market welcomes new entrants
In the past year, the medical device market has undergone a phased adjustment under the background of anti-corruption. However, with the normalization of anti-corruption and the further release of shelved demand, the equipment market will gradually stabilize and pick up.
At the national level, high attention is paid to the development of innovative drugs and medical devices. Since the beginning of this year, the promotion policies for the biomedical and medical equipment industries have been successively released.
In July this year, the Decision of the Central Committee of the Communist Party of China on Further Comprehensively Deepening Reform and Promoting Chinese-style Modernization was adopted, which involves the development of the medical equipment industry. Specifically, it includes "improving and promoting the development policy and governance system of strategic industries such as new generation information technology, artificial intelligence, aerospace, new energy, new materials, high-end equipment, biomedicine, quantum science and technology", "improving and strengthening the development system and mechanism of key industrial chains such as integrated circuits, industrial mother-machines, medical equipment, instruments and meters, basic software, industrial software, and advanced materials" and "improving" Support innovative drug and medical device development mechanisms."
At the press conference of The State Council Information Office held on September 13, Li Li, director of the State Medical Products Administration, said that the drug regulatory authorities are planning a package of policy measures to comprehensively deepen the reform of drug supervision in accordance with the plenary session, focusing on creating a globally competitive pharmaceutical innovation ecology, and accelerating the listing of innovative drugs and medical devices. Improve the quality and efficiency of the development of the pharmaceutical industry.
Among them, for innovative drugs and medical devices supported by the State, strengthen service guidance in the review and approval, inspection and verification, and guide enterprises to adhere to the clinical value-oriented, patient-centered development strategy. Improve the accessibility of innovative drugs and medical devices, implement the decision and deployment of the Party Central Committee on deepening the coordinated development and governance of the "three medical", and actively support the introduction of innovative medical devices into hospitals and medical insurance.
It is reported that from January to August this year, the State Food and Drug Administration approved 46 innovative medical devices, an increase of 12.16% over the same period last year. Surgical robots, artificial hearts, carbon ion treatment systems and other high-end medical devices have been listed, and some products are in a leading position in the world.
On the demand side, there was a relatively large amount of in-hospital medical equipment updating demand that was not released nationwide.
In March, The State Council issued the Action Plan for Promoting large-scale equipment renewal and replacing old consumer goods with new ones, which clarified that by 2027, the scale of equipment investment in medical and other fields will increase by more than 25% compared with 2023
In the medical field, the above "plan" proposes to strengthen the construction of a high-quality and efficient medical and health service system, promote the iterative upgrading of medical and health institutions' equipment and information facilities, and encourage qualified medical institutions to accelerate the renewal and transformation of medical equipment such as medical imaging, radiation therapy, remote diagnosis and treatment, and surgical robots. Promote the transformation and upgrading of wards in medical institutions, and make up for the shortcomings of ward environment and facilities.
Previously, many provinces and cities across the country have been clear medical equipment procurement plans, the relevant demand will be gradually released in the next few years, when the high-end medical equipment is expected to accelerate into the hospital.
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