July 23, 2019

NMPA (CFDA): Three New Requirements Posed on E-Submission

NMPA (CFDA) issued “Notice on Requirements for Medical Device Electronic Submission” on July 10. It lists three requirements which are to be implemented on August 1, 2019. When registering imported […]
July 17, 2019

China Med Device interviewed by BioWorld on AI-Aided Software Guideline

NMPA published Technical Guideline on AI-Aided Devices on June 28, 2019. Grace Fu Palma, CEO of China Med Device, and Zhiyong Rao, Testing Director of China Med Device, were interviewed […]
July 10, 2019

NMPA (CFDA) News Roundup 201906

The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC […]
July 8, 2019

How to Advertise Your Medical Device in China?

Q: What regulations are applicable for advertising medical devices in China? A: The current applicable regulations include: Methods of Medical Device Advertisement Reviewing (NMPA NO. 65, 2009) Advertising Law of […]
July 3, 2019

NMPA (CFDA) Final Guideline on AI-Aided Software: Propels China to the Leadership of AI Applications

NMPA (CFDA) issued the Technical Guideline on AI-Aided Software on June 28, 2019.  After the draft version issued on February 1, nearly five months of efforts have been made to classify the vital evaluation points […]