New Clinical Trial Exemption Lists for Medical Devices and IVDs

On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.

This new clinical trial exemption list is effective since the date of announcement on 20th December.

Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.