April 8, 2019

Overseas Companies Qualify for Innovation Approval, while All Approved are Domestic

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

The Implied Approval of Clinical Trial for Medical Device Takes Effect on April 1, 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

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 […]