China’s NMPA has released requirements for the Temporary Import of Class II and Class III Medical Device for Urgent Clinical Need into China. They came into effect on publication on June 19, 2024. This follows a draft that was published by the National Medical Products Administration (NMPA) for industry comments at the end of 2023.
Class III Medical Device & Class II Medical Device
This regulation pertains specifically to Class II and Class III medical devices required for urgent clinical use, excluding those covered by large-scale medical equipment configuration licenses. “Urgent clinical need” is defined as the necessity to treat or prevent life-threatening diseases when no effective treatments are available in China.
Responsibilities of Medical Institutions
Medical institutions must manage the clinical use of the devices, ensuring safety and quality through formal agreements with manufacturers or agents. These agreements should outline each party’s obligations, including liability for any issues that arise.
Fees and Implementation
Fees for temporary import and use are governed by the medical security department. The regulations take effect from their promulgation date, with provinces authorized by the State Council following these guidelines.
Requirements for Medical Institutions
Hospitals must have a strong track record in treating difficult diseases, appropriate departments with leading experience, and senior experts to manage the use of Class II and Class III medical devices. A robust quality management and adverse event monitoring system is also required.
Application Material Requirements
Applications must include comprehensive documentation, with translated materials if necessary, and be stamped with the medical institution’s official seal. A letter of authorization and the handler’s ID must also be included.
Further information
Read the original announcement on Class II and Class III Medical Device Temporary Import for Urgent Clinical Need in China.
Help from Cisema
If you would like assistance on evaluating whether your Class II and Class III medical device meets the requirements for urgent clinical need in China or in identifying hospitals and clinicians, please contact Cisema.
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