March 8, 2020

Two Domestic IVD Companies Obtained Innovation Approval

NMPA granted two Innovation Approvals in February. Suzhou Beikang: Pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing) Xiamen Feishuo: Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 […]
March 6, 2020

NMPA Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent Issued

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 major regulation after the Guideline […]
March 4, 2020

First Unapproved Cosmetic Device Enters Hainan

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 but urgently-needed medical devices. On […]
March 3, 2020

China Med Device, LLC Consults Local NMPA on Emergency Approval

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 the procedures of emergency approval, […]
February 28, 2020

Device Needs for Coronavirus Could Give Overseas Manufacturers Faster Access to China

To address the Coronavirus outbreak, China’s health system recently eased approval rules to allow for critically needed devices and diagnostics. While dozens of domestic devices have received Emergency Approvals, overseas […]