Regulatory Open Forum

NPMA (formerly CFDA) published the "Clinical Exemption Catalog for Medical Devices" yesterday (Sep 30^th), 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 4^th batch was released on June 11^th, 2018:

1. Compared with the first 3 batches, the latest one includes 63 Class II, 21 Class III medical devices and 246 Class II, 31 Class III IVDs;
2. Class II non-active surgical devices, neuro surgical devices, cardio surgical devices, ophthalmic surgical devices, obstetrics & gynecology devices, Assisted Reproductive Technology (ART) devices and birth control devices are exempted from clinical trial now;
3. Reagents for flow cytometry, newly-classified as class II IVD, have been exempted;
4. It is the first time 31 class III IVDs being exempted, which are cancer-biomarkers.

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 1^st.

 

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 http://chinameddevice.com/clinical-trial-and-cer/

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE. 

 

About China Med Device, LLC 

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. 

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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com
978-390-4453
www.chinameddevice.com
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