July 19, 2024

In a significant move to address urgent clinical needs, China's National Medical Products Administration (NMPA), in collaboration with the National Health Commission, has issued the "Management Requirements for the Temporary Import and Use of Medical Devices by Medical Institutions in Clinical Emergencies" (Announcement No. 97 of 2024). This initiative aims to enhance the accessibility of critical medical devices in special circumstances, thereby improving public health and patient welfare.

The new regulations, referred to as the "Management Requirements," are designed to fully implement the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739). They emphasize a patient-centric approach, prioritizing the health and safety of the public. The guidelines specify the range of products and medical institutions covered, clarify the responsibilities of medical institutions, operating enterprises, overseas manufacturers, and agents, and outline the necessary application materials, procedures, review methods, and timelines. Additionally, they set forth requirements for medical institutions to maintain records, cease usage, analyze reports, and continue using the relevant medical devices.

The "Management Requirements" apply to the temporary import and use of second and third-class medical devices that are already available internationally but have not yet been approved for use in China. These regulations exclude large medical equipment that requires configuration permits. The term "clinical urgency" refers to situations where there are no effective domestic treatments or preventive measures, and the devices are needed for the treatment of severe, life-threatening diseases.

Given that these medical devices are not yet approved in China, the "Management Requirements" also specify that only high-level medical institutions with a leading position in their respective fields can use them. These institutions must have extensive experience in treating complex and critical diseases, possess the necessary specialized departments, and have years of experience using similar medical devices. The relevant departments should be at the forefront of clinical application of such products in China. Furthermore, the medical teams using these devices must include senior experts in the relevant fields to ensure the quality of product use and patient safety.

Moving forward, the NMPA and the National Health Commission will continue to support the implementation of these regulations, providing training and guidance to address specific medical needs effectively. This initiative is expected to significantly improve the availability of essential medical devices in critical situations, ultimately enhancing the health and well-being of the public.