In order to fully implement the requirements of the "Medical Device Supervision and Administration Regulations" (State Council Order No. 739) and further meet the needs of specific clinical urgent medical devices, the National Medical Products Administration, together with the National Health Commission, issued the "Management Requirements for Temporary Import and Use of Medical Devices Urgently Needed in Clinical Practice in Medical Institutions" (Announcement No. 97 of 2024, hereinafter referred to as the "Management Requirements"), effectively improving the accessibility of medical devices urgently needed in clinical practice under special circumstances and effectively improving the health and well-being of the people.

The "Management Requirements" adhere to the people-oriented principle, give priority to protecting people's health, fully consider the medical device needs of patients under special circumstances, determine the product scope and medical institution scope; clarify the responsibility identification requirements of medical institutions, operating enterprises and overseas manufacturers and agents; stipulate application materials, application procedures, review methods and time limits; and put forward requirements for medical institutions to keep records, stop using, analyze reports, and continue using corresponding medical devices.

The "Management Requirements" apply to medical institutions that temporarily import and use medical devices due to urgent clinical needs of patients, which have been launched overseas but no similar products have been launched in China, and do not include equipment that should be included in the configuration license management of large medical equipment. Among them, clinical urgent need refers to the need for clinical prevention and treatment of serious life-threatening diseases when there is no effective treatment or prevention method in China.

Considering that the corresponding medical devices are not listed in my country, the "Management Requirements" stipulate that the medical institutions using the corresponding medical devices must be high-level medical institutions in a leading position, have been providing diagnosis and treatment services for difficult and critical diseases for many years in the corresponding treatment field, have the treatment capabilities of the corresponding difficult and critical diseases, have the corresponding professional departments, and have many years of experience in using similar medical devices. The corresponding departments should have the domestic leading level in the clinical application field of such products, and the medical team using the corresponding medical devices should include senior experts in the corresponding field, so as to ensure the quality of product use and the safety of patients using the devices.

The National Medical Products Administration will continue to implement the work together with the National Health Commission, strengthen training and guidance, and actively solve the problem of patients' small number of specific medical needs.