NPMA (formerly CFDA) published the “Clinical Exemption Catalog for Medical Devices” yesterday (Sep 30th), in which a total of 855 medical devices and 393 IVDs exempted from clinical trial. It is the effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard.
To determine whether your device & IVD falls into the Catalog, please email info@ChinaMedDevice.com.
Since 2014 August, 4 batches of clinical exemptions have been issued by NMPA (formerly CFDA). The 4th batch was released on June 11th, 2018:
For combination devices, it can be exempted If class I device combines with exempted class II or class III device.
The product name, classification code and product description are formatted in the Catalog, in accordance with Medical Device Classification Catalog effective on Aug 1st.
For NMPA (formerly CFDA) link of Medical Device Catalog, please email info@ChinaMedDevice.com. We charge nominal fees if you want to purchase the English version.
For Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents (draft), click HERE.
For webinar on NMPA (formerly CFDA) clinical trial & CER, please visit https://chinameddevice.com/clinical-trial-and-cer/
China Med Device, LLC (www.ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. 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.