2018 CFDA Medical Device Registration Report

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2018 CFDA Medical Device Registration Report

NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China.

I. Domestic V.S Imported

Imported Class III medical devices and IVDs outnumbered domestic Class III, for the first time, since the publication of Registration Report in 2015.

For our comments on NMPA Classification Catalog, please click HERE.

II. Most Imported Devices

Imaging equipment, IVD and implantable devices are among the most imported. In 2017, implantable devices, artificial organs and imaging equipment were imported most.

III. Which Countries Got the Most Approvals?

The U.S, Germany and Japan had the most initial registrations.

For China Tariff Waiver Plan issued in May 2019, please click HERE.

IV. NMPA Recommended Innovative Devices

Each year NMPA Registration Report lists the high-end and much needed innovative devices to domestic and overseas manufacturers for reference.

For NMPA Innovation Approval Procedure, please click HERE.

For English version of 2018 Registration Report, please email info@ChinaMedDevice.com.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, PTR, clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection etc). Our commercialization services include market research, reimbursement, partnership strategy, and distribution qualification.