The National Medical Products Administration (NMPA) has released an updated version of the “List of Medical Devices Exempted from Clinical Evaluation,” which is effective immediately. This list is a significant guide for medical device manufacturers, particularly regarding the clinical trial requirements for different classes of devices in China.
Clinical Trial Exemptions for Class I, II, and III Medical Devices
According to the updated guidelines, Class I medical devices in China are exempt from clinical trials when applying for marketing approval. For Class II and III devices, clinical evaluation is required. However, there is a provision that allows for exemption from clinical trials if a device has a mature process and can demonstrate safety and efficacy through non-clinical evaluation or data analysis of similar medical devices.
Revision of Previous Lists and Expansion of Exemptions
Previously, the China Food and Drug Administration released the List of Class II Medical Devices Exempt from Clinical Trials and the List of Class III Medical Devices Exempt from Clinical Trials in 2014. These lists have been updated to reflect changes in the medical device industry and regulatory requirements. The revised list now includes 1,024 Class 2 and Class 3 medical devices, in addition to medical device products classified as Class II after sterilization in the Class I medical device list.-Fineline Info & Tech
