In order to fully implement the Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 739), and to further meet the demand for specific medical devices in urgent clinical need, the National Medical Products Administration (NMPA), in collaboration with the National Health Commission, has issued the Management Requirements for Temporary Import and Use of Medical Devices in Urgent Clinical Need in Medical Institutions (Announcement No. 97 of 2024, hereinafter referred to as the Management Requirements). This initiative aims to effectively enhance the accessibility of medical devices in urgent clinical need under special circumstances, thereby genuinely improving the health and well-being of the public.

The Management Requirements adhere to a people-centered approach, prioritizing the protection of public health. It fully takes into account the urgent need for medical devices in special situations, defining the scope of products and medical institutions. It clarifies the requirements for determining the responsibilities of medical institutions, distributors, and overseas manufacturers and agents. It also specifies the application materials, procedures, review methods, and timelines. Additionally, it outlines requirements for record-keeping, cessation of use, analysis reports, and continued use of the relevant medical devices by medical institutions.

The Management Requirements apply to the temporary import and use by medical institutions of Class II and Class III medical devices that are available in the overseas market but have no predicate device available in China due to the urgent clinical needs of patients. These devices do not include those that should be subject to large medical equipment configuration licensing management. The term "urgent clinical need" refers to the need for methods to prevent or treat serious life-threatening diseases for which there are no effective treatment or prevention methods in China.

Given that the relevant medical devices have not been approved for marketing in China, the Management Requirements stipulate that the medical institutions using these devices must be a leading high-level medical institutions with extensive experience in the diagnosis and treatment of complex and critical conditions in the relevant therapeutic areas for many years, have the ability to treat such conditions, have appropriate specialized departments and have many years of experience in the use of similar medical devices; the relevant departments should be at the forefront of clinical application of this type of device; and the medical teams using the devices should include senior experts in the field to ensure the quality of product use and patient safety.

The NMPA, in conjunction with the National Health Commission, will continue to implement these requirements, strengthen training and guidance, and actively address a small number of specific medical needs of patients.