Blogs

January 11, 2018

China’s “Three-Year Action Plan for Enhancing the Core Competence of Medical Device Manufacturing Industry (2018 – 2020)”

  Recently, in order to speed up the development of advanced manufacturing industries, promote the deep integration of the Internet, big data, artificial intelligence and real economy, and break through […]
January 11, 2018

Key Takeaways from CFDA’s “Medical Devices Online Sales Supervision and Management Measures”

As planned, CFDA is to enforce its “Medical Devices Online Sales Supervision and Management Measures” on March 1st, 2018 that governs online sales of all medical devices in China.   […]
January 10, 2018

CFDA Issued Registration Technical Review Guidelines for Mobile Medical Devices

1. Scope This guideline applies to the application registration of class II and III mobile medical devices. 2. Mobile Medical Device (1) Definition of Mobile Medical Device A “mobile medical […]
January 8, 2018

Take Advantage of CFDA’s Priority Channel For Your Medical Device

As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA opened up its priority review […]
January 5, 2018
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FDANews Webinar on Jan 17: How to Get IVD Approval Through CFDA

Learn Key CFDA Premarket Submission Tips for IVD Approval Register here for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST Marketing medical devices and IVD […]