June 27, 2019

Suspension of Importation to China by CFDA after Overseas Inspection

In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, […]
June 25, 2019

Clinical Trial and CFDA Inspection Success for Hemostatic Powder by ChinaMed Device, LLC

ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA […]
June 21, 2019

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. […]
June 19, 2019

CFDA Newsletter (May 2019)

The NMPA (CFDA) Newsletter covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
June 14, 2019

CFDA Publishes 27 Industry Standards in One Day: Time to Update Your Design Control

NMPA (CFDA) announced revisions of 27 medical device technical standards on June 6, 2019, involving multiple devices including Co-60 Teletherapy Unit, Infusion Sets with Precision Filters for Single Use and […]
June 7, 2019

NMPA: E-Submission to be effective on June 24, 2019

NMPA (CFDA) issued the “Notice on Implementation of Electronic Submission System for Medical Device Registration” and “Technical Guideline on Registration Material Requirements for Electronic Submission System” on May 31. The […]