Recently, in order to actively respond to the urgent needs of patients for special medical devices in clinical practice, the National Medical Products Administration (NMPA), together with the National Health Commission, officially issued the "Management Requirements for Temporary Import and Use of Medical Devices in Urgent Clinical Needs of Medical Institutions" (hereinafter referred to as the "Management Requirements"). The introduction of this policy marks a solid step forward for China in improving the accessibility of urgently needed clinical medical devices, bringing new hope to the vast number of patients. The "Management Requirements" point out that this policy aims to address the temporary import and use of Class II and Class III medical devices (excluding large medical equipment) that have not yet been effectively treated or prevented domestically and have been marketed abroad but have not yet been approved for sale domestically. This policy puts patients at the center, prioritizes safeguarding people's health, and ensures that in special circumstances, patients can receive necessary medical equipment treatment in a timely manner, effectively improving their quality of life and health level. It is reported that in order to ensure the quality of medical devices and the safety of patients, the "Management Requirements" set strict conditions for medical institutions applying for temporary import of medical devices. These medical institutions must be tertiary Grade A hospitals with high-level medical technology and service capabilities, possessing years of experience in the diagnosis and treatment of difficult and critical diseases in the corresponding treatment field, as well as corresponding treatment capabilities, professional departments, and rich experience in the use of similar medical devices. In terms of application process, the "Management Requirements" stipulate detailed application materials and procedures. Medical institutions are required to submit comprehensive information to the National Medical Products Administration, including application forms, medical device related materials, necessity and feasibility assessment materials, supporting documents, and commitment letters. The National Medical Products Administration will organize technical review departments and experts to conduct audits, and organize expert groups for argumentation as needed to ensure the scientific and impartial nature of decision-making. At the same time, the Management Requirements also emphasize quality management and adverse event monitoring during the use of medical devices. Medical institutions need to establish a sound quality management system and adverse event monitoring system, store medical records generated during use for a long time, and immediately stop using them when serious adverse events occur or quality and safety hazards are discovered. In addition, medical institutions are required to report the evaluation of the temporary import and use of medical devices to the provincial drug supervision and management department every year to ensure the safety and effectiveness of the products. The National Medical Products Administration and the National Health Commission have stated that they will make every effort to implement the "Management Requirements" and ensure the effective implementation of policies and the safety of patients' use of equipment through measures such as strengthening training guidance, strict supervision and evaluation. At the same time, it also calls on medical institutions and medical device operators to comply with legal and regulatory requirements and safeguard the health rights and interests of patients. (New Society)