March 23, 2020

NMPA: More Access to Increase Patient Samples in Clinical Trial

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 of publication. The draft version […]
March 19, 2020

Guideline on AI Imaging Software for Coronavirus: Four Keywords to Keep in Mind

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 AI software manufacturers on the […]
March 18, 2020

NMPA Roundup February Coronavirus Special Issue

Amid the novel Coronavirus (COVID-19) outbreak, we deliver the Coronavirus Special Roundup to give you insights on the measures China NMPA has taken to handle its insufficient medical resources and […]
March 13, 2020

Practical Lessons for Coronavirus Related Products Fast Track Clearance in China

Wednesday, March 18, 2020 | 12:00 pm – 12:45 pm ETIn response to the Novel Coronavirus (COVID-19) outbreak, China regulatory agencies issued over 70 Emergency Approvals of medical devices, including diagnostic […]
March 10, 2020

Big Step! NMPA Streamlines Registration Procedure for Imported Devices!

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 to be submitted by March […]
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 […]
February 27, 2020

Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry (II)

Picture by BBC News Amid the COVID-19 crisis, China NMPA has taken many measures to handle its insufficient medical resources. Along with emergency approval procedures and the importation of non-NMPA […]
February 26, 2020

Where the Real-World Data Come from? NMPA New Guideline Reveals

Real-world data (RWD) is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings. Real-world data refers to observational data […]