On June 11, CFDA published "4
th Batch of Clinical Exempted Medical Devices and IVDs (Draft)".85 medical devices and 277 IVDs have been newly-exempted from clinical trial in the 4
th batch. Also, it is the first time 31 class III IVDs, cancer biomarkers, have been exempted.
Since 2014 August, a total of 1466 medical devices and IVDs have been granted exemption from clinical trial:
Class II medical device: 858
Class III medical device: 201
Class II IVD: 376
Class III IVD: 31
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.
About China Med Device, LLC
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 200+ companies' success.
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------