NMPA has been steadily expanding the list of general medical devices and in-vitro diagnostic reagents which are exempt from clinical trials, since 2018. Back then, NMPA had issued the Notice on the Publication of the Newly Revised List of Medical Devices Exempt from Clinical Trials (No. 94 of 2018), which covered 855 general medical device products and 393 in-vitro diagnostic reagents. This list further swelled in 2019, with 148 more general medical device and 23 in-vitro diagnostic reagents.
With the new year, the NMPA has further expanded this list, bringing the total number of clinical trial exempted general medical devices as 1088 and 423 in-vitro diagnostic reagents
The newly added list of exempted medical devices can be consulted in this link. These new clinical trial exemption lists are effective since the date of announcement on 19th January 2021.
Feel free to contact us if you would like to check if your device falls under the renewed full list of clinical trial-exempted general medical devices and in-vitro diagnostic reagents in China.
- Summary of medical device catalogs exempt from clinical trials
- List of medical devices exempt from clinical trials (second revision)