【医疗机构临床急需医疗器械临时进口使用管理要求发布实施】
据国家药品监督管理局官方微信最新消息，为确保《医疗器械监督管理条例》（国务院令第739号）的全面落地实施，满足特定临床急需用械需求，国家药监局与国家卫生健康委联合发布《医疗机构临床急需医疗器械临时进口使用管理要求》（2024年第97号公告）。这一重要举措旨在进一步优化医疗器械进口使用流程，保障临床急需医疗器械的及时供应，同时强化监管，确保医疗安全与质量。
该管理要求明确了临时进口使用的具体条件、申请流程、审批程序以及使用后的跟踪与管理。医疗机构需在满足特定临床需求，且国内无法及时供应的情况下，按照规定的程序提出申请，获得国家药监局的审批后方可进口使用。此外，公告还强调了加强进口医疗器械的质量控制与使用安全，确保每一件临时进口的医疗器械均符合国家相关标准和要求。
为确保临床急需医疗器械的高效、安全使用，公告要求医疗机构建立健全医疗器械使用管理制度，对进口医疗器械进行严格的质量检查与使用监测，确保其在整个使用周期内的安全性和有效性。同时，公告鼓励医疗机构与国际医疗器械生产商建立合作关系，探索更多渠道获取临床急需的医疗器械，以应对国内医疗资源的挑战。
国家药监局与国家卫生健康委的这一合作，体现了对医疗健康事业的高度重视，旨在通过优化管理流程、强化监管措施，保障临床医疗质量，提升国民健康水平。未来，相关部门将持续关注医疗器械市场的动态，适时调整管理要求，以适应医疗技术发展和临床需求的变化，确保医疗安全与服务质量的持续提升。
此公告的发布与实施，标志着我国在医疗器械进口使用管理领域迈出了重要一步，将对提升医疗服务水平、保障公众健康权益产生积极影响。
英语如下：
News Title: “New Regulations for the Temporary Import of Clinical Urgent Medical Devices Issued”
Keywords: Temporary Import, Management Requirements, Clinical Urgency
News Content: [“Regulations for the Temporary Import and Use of Urgently Needed Medical Devices in Clinics Released”]
According to the latest information from the National Medical Products Administration’s official WeChat account, in order to ensure the full implementation of the “Regulations for the Administration of Medical Devices” (国务院令 No. 739), and to meet specific needs for urgently needed medical devices in clinical settings, the National Medical Products Administration (NMPA) and the National Health Commission jointly issued the “Regulations for the Management of Temporary Import and Use of Urgently Needed Medical Devices in Clinics” (Announcement No. 97 of 2024). This significant measure aims to further optimize the process of importing and using medical devices, ensuring timely availability of medical devices in urgent clinical situations, while strengthening oversight to ensure medical safety and quality.
The management requirements clarify the specific conditions, application procedures, approval processes, and post-use tracking and management for temporary imports. Hospitals must apply for importation following a set of procedures when there is a specific clinical need and the domestic market cannot provide the required devices in time. The announcement also emphasizes the strengthening of quality control and usage safety for imported medical devices, ensuring that every temporarily imported device meets the country’s relevant standards and requirements.
To ensure the efficient and safe use of urgently needed medical devices, the announcement requires hospitals to establish and implement strict medical device usage management systems, conducting thorough quality checks and usage monitoring on imported devices throughout their lifecycle to ensure their safety and efficacy. Furthermore, the announcement encourages hospitals to establish partnerships with international medical device manufacturers to explore more channels for obtaining urgently needed medical devices, in response to the challenges posed by domestic medical resources.
The collaboration between the NMPA and the National Health Commission reflects a high level of attention to the healthcare sector, aiming to optimize management processes, strengthen oversight measures, and safeguard clinical medical quality to enhance national health levels. In the future, relevant departments will continue to monitor the dynamics of the medical device market, adjusting management requirements as needed to adapt to changes in medical technology and clinical demands, ensuring the continuous improvement of medical safety and service quality.
The release and implementation of this announcement mark a significant step forward in the management of imported medical device use in China, poised to have a positive impact on elevating healthcare service levels and safeguarding public health rights and interests.
【来源】http://www.chinanews.com/life/2024/07-19/10253846.shtml
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