CMD Blogs

Collaborate with AdvaMed, we present: China Adverse Event and PMS June 12, 2019 | 1:00 PM – 02:00 PM EDT Register Here Speaking with Varian VP

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.

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.

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

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

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

According to the Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical

NMPA (CFDA) issued Notice on Classification Procedures for Combination Device on April 17th. The new procedures will be effective on June 1, 2019: A specialized

NMPA (CFDA) issued “Medical Device Animal Study Technical Review Guideline Part I: Decision Principles” on April 19. The guideline lists 12 devices as examples to

“Electronic Regulated Product Submission (eRPS) will come into force by the end of June, 2019”, Zhong Lu, deputy head of NMPA Center for Medical Device