Category: NMPA (CFDA) Updates

Under the COVID-19 crisis, China’s health regulators demonstrated unprecedented speed in providing approvals in mere weeks for needed medical devices, particularly for diagnostic test kits.

Despite the global outbreak of novel coronavirus (COVID-19), NMPA published 16 guidelines and 43 standards in March, guiding manufacturers with type testing and registration. For

NMPA issued the 2020 Medical Device Industry Standards Revisions Plan on March 20, in which 86 medical devices and IVDs are affected. The Standards Revisions

China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (Covid-19) since late January. Two regulatory authorities share the same progress:

The NMPA expert panel convening scientists, medical experts, government officials, manufacturer’s representatives and Clinical Research Organizations (CROs) from transcontinental locations is delivered online for the

NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20, implementing from the date

NMPA published the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia on March 5, 2020. The document provides guidance to

NMPA published the Draft Document of “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” on March 5, 2020 for feedback. Feedbacks need

NMPA granted two Innovation Approvals in February. Suzhou Beikang: Pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing) Xiamen Feishuo: Human EGFR / KRAS / BRAF /

NMPA published Registration Guideline on Novel Coronavirus (Covid-19) Antigen/Antibody Detection Reagent on February 25, addressing the urgent needs of virus diagnostics. It is the second

A focused ultrasound stimulator, designed for cosmetic procedures, is the first aesthetic device to benefit from the Hainan policy to allow the use of unapproved

Manufacturers have many questions on provincial Emergency Approval to help China contain the Coronavirus outbreak. China Med Device called Beijing NMPA on February 25, asking