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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]