The National Medical Products Administration (NMPA) has released new “Management Requirements for Temporary Import and Use of Clinically Urgently Needed Medical Devices in Medical Institutions.” These guidelines are designed to address the special clinical needs of patients by allowing the temporary import and use of medical devices that have been approved abroad but are not yet available in China.
Scope of the New Management Requirements
The document applies to medical devices that are temporarily imported for the prevention and treatment of serious, life-threatening diseases where no effective treatment or prevention measures currently exist in China. This initiative does not extend to equipment that requires large-scale medical equipment configuration licenses.
Application and Review Process
Medical institutions seeking to temporarily import and use medical devices due to urgent clinical needs must submit an application to the NMPA. The NMPA is required to organize an expert review within 10 working days after receiving the application materials. Additionally, within 3 working days of receiving the application, the bureau must seek opinions from the National Health Commission regarding the medical institution’s capability to use and manage the devices, the urgency of the clinical need, and the reasonableness of the requested quantity.
Responsibilities of Medical Institutions
Medical institutions are held responsible for the clinical use of urgently needed medical devices, ensuring that they are used appropriately and effectively to address critical patient needs. This new process by the NMPA aims to balance the urgent need for advanced medical devices with the regulatory oversight necessary to ensure patient safety.-Fineline Info & Tech
