April 10, 2019
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), […]
April 8, 2019
In January 2019 NMPA published Catalog of Innovation Approvals, in which 54 medical devices and IVDs are approved, and 197 medical products are under review. The 54 approved include 22 […]
April 5, 2019
NMPA published Notice of Modification on Medical Device Clinical Trial Approval Procedure on April 1. The Notice allows that, once the receipt of Clinical Trial Application is received, the sponsor […]
March 28, 2019
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
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 […]