On June 11, CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial in the 4th batch. Also, it is the first time class III IVDs (31 cancer biomarkers) have been exempted.
Since 2014 August, a total of 1466 medical devices and IVDs have been granted exemption from clinical trial:
Below are some historical versions:
2nd batch class II IVD: https://chinameddevice.com/cfda-update-cfda-issued-the-draft-of-clinical-evaluation-basic-requirements-for-clinical-exempt-ivd-reagents-along-with-the-2nd-batch-of-clinical-exempt-class-ii-ivd-reagents/
3rd batch class II and class III devices: https://chinameddevice.com/cfda-added-more-class-ii-and-class-iii-devices-to-the-clinical-trial-exempt-list/
Make sure you get the most recent version as CFDA issued several revised ones.
For complete list of the exemptions, please email info@ChinaMedDevice.com.
To determine whether your device or IVD falls into the 4 batches, please email us too. For Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents (draft), click HERE.
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling Innovation Approval and Priority Review. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.