March

March 28, 2019

IMDRF Approves China’s Proposal on Medical Device Evaluation: Bringing China Closer to the International Clinical Standards

On March 21, 2019 the draft proposal of ” Medical Device Clinical Evaluation”, submitted by NMPA (CFDA) at the 13th International Medical Device Regulators Forum (IMDRF) management committee meeting, was […]
March 27, 2019

China First Multiple Biomarker-Based NGS Approved for CDx

NMPA (CFDA) approved the ‘human 10 gene mutation combined detection kit’, manufactured by Amoy Diagnostics, the first of its kind in the CDx (companion diagnostic) category in China on November […]
March 21, 2019

2019 Industry Standards Revision Plan Announced: Huge Impact on Registrations and Renewals

NMPA (CFDA) issued the final version of “2019 Medical Device Industry Standards Revision Plan” yesterday (March 20), in which 93 medical devices, IVDs are affected. The Standards Revisions are aimed […]
March 20, 2019

CFDA News Roundup 201902

Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), […]
March 17, 2019

AdvaMed Webinar: How to Navigate Type Tsting in China

Collaborate with AdvaMed (click link HERE), we present: How to Navigate Type Testing in China Webinar March 20, 2019 | 10:30 – 11:30 am EST Register Here China FDA (NMPA) […]