May 7, 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 (www.ChinaMedDevice.com), […]
May 3, 2019
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
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
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
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, […]