May 17, 2019

NMPA Requirements for IVD Clinical Trial Protocol Design

NMPA published draft version of IVD Clinical Trial Guideline for feedback on November 22, 2018. The draft guideline lists eight requirements for IVD clinical protocol. General information Including product information, […]
May 14, 2019

Varian to Collaborate with Shandong Cancer Hospital on Proton Therapy Application

Varian announced on May 9 that it has signed a cooperation agreement with Shandong Cancer Hospital in China, on proton therapy clinical application and research. Varian has selected Shandong Cancer […]
May 10, 2019

CFDA Taking Actions for AI Device Registration Applications

Primarily due to the pressing problem of doctor shortage, the Chinese government is eagerly encouraging medical use of Artificial Intelligence. Currently, China has two kinds of license for AI medical […]
May 7, 2019

Monthly NMPA News Roundup (April 2019)

Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (, […]
May 3, 2019

What SaMD in China has clinical exemption?

According to Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical device hardware, and operates on a […]