Latest China FDA announcement on the Second Batch of Medical Device Exempted from Clinical Investigation CFDA latest announcement on 30 September 2016 featured the second batch of exemption list for conducting clinical investigation in China. This announcement was following the draft exemption list for manufacturer’s comments which was released in May 2016. There is a total of 359 products that are listed as the Second Batch of Medical Equipment Exempted from Clinical Investigation. This includes 267 of Class 2 medical equipment and 92 of Class 3 medical equipment. CFDA have also included a significant amount of devices in the Clinical investigation exemption list which will result in reducing the amount of local investigation in China.
For devices that is on the final list, the applicant does not have to carry out the clinical investigation. Applicant could now just submit information of the product to be registered with a comparative product information during the product registration. This approach will help to lighten the workload of the industry in registration, increase the efficiency of medical equipment registration review and approval department, as well as to meet the clinical needs in a timely manner.
Click here for the list of 2nd batch of Exempted Class 2 and Class 3.
The following 2 links are the list of First Batch Class 2 and Class 3 products exempted for local clinical investigation which was released in 2014:
Class 2 (a total of 488 products, click here to download the list)
Class 3 (a total of 79 products, click here to download the list)