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 […]
April 29, 2019

New Classification Procedures for Combination Device Take Effect on June 1, 2019

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 department, NMPA Standardization Management Center […]
April 24, 2019

Do You Need Animal Study for Your Device? NMPA Gives 12 Devices as Examples

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 discuss if animal study is […]
April 22, 2019

Common Errors in Writing NMPA IVD Clinical Protocol

Clinical trial protocol is a vital component in IVD clinical design and, in China, the details of the protocol never fail to be questioned by NMPA (CFDA) reviewers.  ChinaMed Device, […]