开幕式上同步举行两项重要仪式：创新药械技术引进专家委员会筹备启动仪式正式启动，将汇聚各 领域权威院士专家，推动创新药械引进决策科学化、临床需求对接精准化;"创新之光"药械颁奖仪式同 期举办，对一批具有代表性的创新产品和合作机构进行了表彰，大会还设立了"先行先试"突破创新奖等 多个奖项，对在医疗创新领域取得突出成果的相关主体予以表彰，激励产业链上下游的各方伙伴继续深 化合作。 本次博览会汇聚全球医疗创新智慧，集中发布100余款国际创新药械、特医食品及生物医学新技 术，权威发布《海南博鳌乐城国际医疗旅游先行区国际创新药械引进及使用白皮书》。此外，博览会还 助力搭建"政企研"精准对接平台，为全球医疗健康产业注入新动能。 海南日报博鳌11月21日电(海南日报全媒体见习记者 陈美如)11月21日，海南博鳌乐城首届全球创 新药械博览会在乐城先行区开幕。 本届博览会以"智汇全球创新技术，共筑人类健康未来"为主题，汇聚了国内外政府代表、医疗机 构、科研院所、高校专家及企业代表约700人，旨在搭建全球医疗科技交流合作平台，开展全球创新药 械及医疗技术研发趋势与临床应用研讨活动，深化药械研发、生产、流通全链条协同合作，推动国际前 ...

Group 1 - The Boao Lecheng International Medical Tourism Pilot Zone is recognized for its policy advantages and investment opportunities, attracting interest from various enterprises [2][3] - A delegation of representatives from 26 companies and industry experts visited the pilot zone to explore the integration of global medical innovations and local healthcare needs [2][3] - The zone has established a "green channel" for connecting Chinese patients with the latest global medical products, facilitating the introduction of innovative medical devices and special medical foods [3] Group 2 - As of September 2025, the Shanghai Jiao Tong University affiliated Ruijin Hospital in Hainan has successfully implemented 186 special medical device projects and 2 special medical food projects, benefiting over 26,800 patients [3] - The pilot zone has created an efficient collaborative ecosystem involving medical institutions, medical device companies, research institutions, and regulatory bodies to ensure timely delivery of innovative healthcare solutions [3] - The integration of traditional Chinese medicine with modern health management at the Yiling Life Care Center showcases the potential for growth in the "medical + health management" sector within the pilot zone [3]

Core Viewpoint - The "Regulations on the Management of Clinical Research and Clinical Translation Applications of New Biomedical Technologies" will take effect on May 1, 2026, aiming to enhance the management of biomedical technology research and application in China [1] Group 1: Background and Purpose - Biomedical technology has significant potential in disease prevention, diagnosis, and treatment, driving medical progress and health development [2] - The regulations aim to improve the management system for clinical research and application of new biomedical technologies, ensuring safety and quality in medical practices [2] Group 2: Overall Approach - The regulations focus on prioritizing public health, risk prevention, and safety assurance while promoting innovation in biomedical technology [3] - Responsibilities of clinical research institutions and sponsors are clearly defined to ensure accountability [3] Group 3: Scope of Application - The regulations apply to clinical research and translation applications of biomedical technologies within China, defining biomedical technologies as those that operate at the cellular and molecular levels [4] Group 4: Regulations on Clinical Research - Clinical research can only commence after non-clinical studies prove safety and efficacy, and after ethical reviews [5] - Clinical research institutions must adhere to approved research protocols and conduct follow-up monitoring of participants [5] Group 5: Support for Clinical Translation Applications - The regulations establish conditions and procedures for the clinical translation of biomedical technologies, requiring approval from health authorities [6][7] - Quality and safety of clinical applications are emphasized, with specific requirements for medical institutions and personnel [6] Group 6: Protection of Participants' Rights - The regulations outline the protection of participants' rights, including obtaining informed consent and ensuring no fees are charged for participation [8] - Institutions are encouraged to provide insurance for participants and protect their personal information [8] Group 7: Implementation Measures - The National Health Commission will enhance awareness and understanding of the regulations through training and outreach [9] - Development of supporting systems and personnel training is essential for effective implementation of the regulations [9]

Core Points - The regulation aims to standardize the clinical research and application of new biomedical technologies, promoting medical science and technology innovation while ensuring safety and ethical standards [2][3] - The regulation defines new biomedical technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or preventing and treating diseases [2][4] - The regulation emphasizes a people-centered approach, encouraging innovation while balancing development and safety [2][4] Chapter Summaries General Principles - The regulation is applicable to all biomedical technology clinical research and applications within the territory of the People's Republic of China [2] - It mandates that all research must have scientific backing, comply with laws and regulations, and prioritize the health and rights of participants [2][4] Clinical Research Filing - Clinical research must be preceded by laboratory and animal studies to ensure safety and efficacy before human trials can commence [4][5] - Institutions initiating clinical research must be legally established entities within China and ensure that the technology has been proven safe and effective through non-clinical studies [5][6] Implementation of Clinical Research - Clinical research must be conducted according to the approved research plan, and any changes must be reported to the health department [11][12] - Institutions must obtain informed consent from participants, ensuring they understand the research's purpose and potential risks [19][21] Clinical Application - After successful clinical research, the application of new biomedical technologies in clinical settings requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32][33] Supervision and Management - Local health departments are responsible for supervising and inspecting clinical research and applications, with the authority to impose penalties for violations [39][40] - An online service system will be established to facilitate the filing and reporting processes for research institutions [42][43] Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of research activities and revocation of licenses for responsible personnel [23][24][25] - Institutions must ensure the accuracy and completeness of all submitted materials and reports [10][11] Miscellaneous - The regulation will come into effect on May 1, 2026, allowing existing research to continue under the new framework [31][32]

Core Points - The regulation aims to standardize clinical research and application of new biomedical technologies, promoting medical science and ensuring safety and ethical standards [1][2] - The regulation emphasizes the importance of prioritizing public health, innovation, and safety in the development and application of biomedical technologies [1][2] Group 1: General Principles - The regulation defines biomedical new technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or treating diseases [1] - It mandates that all clinical research must be based on scientific evidence and comply with legal and ethical standards [1][2] Group 2: Supervision and Management - The State Council's health department is responsible for overseeing the clinical research and application of biomedical technologies at the national level [2] - Local health departments are tasked with managing and supervising these activities within their jurisdictions [2] Group 3: Clinical Research Registration - Institutions must conduct non-clinical research to prove the safety and efficacy of new technologies before initiating clinical trials [3][4] - Clinical research institutions must meet specific criteria, including being a tertiary hospital and having the necessary ethical and academic committees [4][5] Group 4: Implementation of Clinical Research - Clinical research must be conducted according to approved protocols, and any changes must be reported to the health department [7][8] - Informed consent from participants is mandatory, and institutions cannot charge participants for research-related costs [19][20] Group 5: Clinical Application - After successful clinical research, the application of biomedical technologies requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32] Group 6: Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of clinical research activities [43][44] - Institutions providing false information during the application process may face severe consequences, including the revocation of licenses [51][52]

Core Points - The State Council of China has issued the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," effective from May 1, 2026, aimed at standardizing clinical research and promoting innovation in medical science [1][2]. Group 1: Overall Requirements - The regulations emphasize a health-centered approach, innovation-driven development, and a balance between development and safety, encouraging clinical research while enhancing safety management throughout the process [1]. Group 2: Clinical Research Regulation - Biomedical new technologies must demonstrate safety and efficacy through non-clinical research and undergo academic and ethical reviews before clinical research can commence. Clinical research must be filed with the National Health Commission, which will evaluate and address risks [1][2]. - The rights of participants in clinical research are protected, prohibiting any fees from being charged to participants and ensuring timely treatment for any health damages incurred [1]. Group 3: Support for Translation Applications - Biomedical technologies that are proven safe and effective can be translated into clinical applications upon approval from the National Health Commission, which will also publish the conditions for medical institutions and professionals involved [2]. - The National Health Commission is responsible for re-evaluating the clinical applications of biomedical technologies based on scientific advancements, prohibiting applications that cannot ensure safety and efficacy [2]. Group 4: Legal Responsibilities - The regulations impose strict legal responsibilities for violations in the clinical research and translation application processes of biomedical technologies [3].

Core Viewpoint - The State Council's executive meeting approved the draft regulation for the management of clinical research and clinical application of new biomedical technologies, aiming to promote innovation and development in China's biomedical technology sector while ensuring safety and quality in clinical applications [1] Group 1: Regulation and Development - The regulation aims to accelerate the research and application of biomedical technologies, enhancing the quality and upgrading the biomedical industry [1] - Biomedical technology is recognized as one of the fastest-growing and most challenging fields, providing new means for disease diagnosis and treatment while posing risks related to privacy, biosecurity, public safety, and social ethics if mismanaged [1] Group 2: Safety and Quality Assurance - The meeting emphasized the importance of balancing development and safety, advocating for legal regulation of clinical research to ensure quality and safety in clinical applications [1] - The regulation is expected to clarify responsibilities among research institutions, enterprises, and medical organizations, strengthening risk warning and emergency management [1] Group 3: Impact on the Industry - The establishment of the regulation is seen as a significant step towards modernizing the governance system and capabilities in the biomedical field, facilitating the translation of cutting-edge biomedical technologies to benefit the public [1]

Core Points - The State Council's executive meeting approved the draft regulation for the management of clinical research and clinical application of biomedical new technologies, aiming to promote innovation and accelerate the transformation of research results in the biomedical industry [1] - The meeting emphasized the importance of balancing development and safety, ensuring the quality and safety of clinical applications while effectively preventing various risks [1] - The regulation aims to facilitate medical progress, ensure healthcare quality and safety, and protect human dignity and health by clarifying responsibilities among research institutions, enterprises, and medical institutions [1] Summary by Categories Regulation and Management - The draft regulation is designed to standardize the clinical research and application of new biomedical technologies, which is crucial for medical advancement and patient safety [1] - It aims to break down barriers between research and application, accelerating the benefits of cutting-edge biomedical technologies to the public [1] Industry Impact - The regulation is expected to enhance the quality and safety of medical services, thereby fostering the development of the biomedical industry [1] - By establishing clear responsibilities and enhancing risk warning and emergency management, the regulation marks a significant step towards modernizing governance in this field [1]

Core Viewpoint - The State Council's executive meeting approved the draft regulation for the management of clinical research and application of new biomedical technologies, aiming to promote innovation and development in China's biomedical technology sector [1] Group 1: Regulation and Development - The regulation aims to accelerate the research and application of biomedical technologies, enhancing the quality and upgrading the biomedical industry [1] - It emphasizes the importance of balancing development and safety, ensuring that clinical research is conducted legally and that the quality and safety of clinical applications are guaranteed [1] Group 2: Industry Implications - The regulation is expected to facilitate medical advancements while ensuring the safety and quality of healthcare, thereby protecting human dignity and health [1] - By clarifying the responsibilities of research institutions, enterprises, and medical organizations, the regulation aims to strengthen risk warning and emergency management, marking a significant step towards modernizing governance in this field [1]