The National Medical Products Administration (NMPA) and the National Health Commission have issued the Management Requirements for Temporary Import and Use of Clinically Urgent Medical Devices in Medical Institutions, which are set to take effect immediately. This new regulation is designed to address the urgent clinical needs of patients by allowing the temporary import and use of certain Class II and Class III medical devices that have been marketed internationally but have not yet received marketing approval in China. The document explicitly excludes equipment that falls under the management of large-scale medical equipment configuration licenses.
Eligible medical institutions must be Class 3A hospitals that fulfill the specified requirements and will be held responsible for the clinical use management of these urgently needed medical devices. To ensure quality and safety standards are met, medical institutions, medical device operators, and overseas medical device manufacturers or their agents must enter into quality agreements or agency agreements. These agreements will delineate the quality and safety obligations and responsibilities of all parties involved, including compensation obligations and responsibilities.- Flcube.com
