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 […]
February 22, 2020
medical device CER

Clinical Evaluation Report (CER) for Medical Devices/IVD in China

In this article we will provide a general introduction about Clinical Evaluation Report (CER) for medical devices registration and application in China. Current regulations in both China and EU require […]
February 21, 2020

NMPA News Roundup January 2020

Here’s the latest regulatory news for January 2020 affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague […]