April 16, 2020

Regulatory Guidance on COVID-19 Give IVD Manufacturers Lessons on Seeking China Approval

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. Jiangsu provincial NMPA approved the […]
April 11, 2020

NMPA under Pandemic: Record Number of Guidelines and Standards Issued in March

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 English version of any documents […]
April 9, 2020

NMPA Standards Revisions Plan: Nine Mandatory Standards to be Issued in 2020

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 are aimed to facilitate manufacturers […]
April 6, 2020

NMPA V.S FDA — Regulatory Response to the Coronavirus (COVID-19) Pandemic

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: Emergency approval channels have been […]
April 2, 2020

NMPA’s Multinational Expert Panel Meeting Going Virtual

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 first time. The virtual conference […]