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 […]
June 27, 2019

Suspension of Importation to China by NMPA (CFDA) after Overseas Inspection

In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, […]
June 25, 2019

Clinical Trial and NMPA (CFDA) Inspection Success for Hemostatic Powder by ChinaMed Device, LLC

ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA […]