On January 19, 2021, the NMPA (National Medical Products Administration) announced (No.3-2021) the new clinical trial exemption list for medical devices and in-vitro diagnostics reagents. 21 new class II and 14 new class III products were added to the exemption list whilst 16 class II products were down-classified to class I.
Clinical trials won’t be required for medical devices and in-vitro diagnostic reagents appearing on the new exemption list when applying for NMPA certification.
A breakdown of the new exemption list is provided below in comparison to the previous year:
|Clinical Trial Exemption List for Medical Device||803||200||808||214|
|Clinical Trial Exemption List for IVD||370||46||374||49|
The new clinical trial exemption list is already in effect since the date of the announcement on January 19, 2021.
By Jacky Li. Contact Cisema if you would like to learn more.