August 13, 2019

NMPA (CFDA) GMP for Software: Eight Requirements You Must Follow

NMPA (CFDA) published Good Manufacturing Practice Annex on Standalone Software on July 12. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers have to meet the eight special requirements […]
August 6, 2019

NMPA (CFDA) Roundup 201907

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 […]
August 2, 2019

24 Industry Standards in July: Time to Update Your Design Control

NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30. If these standards are applicable to your device, please check your product’s design file and your […]
July 30, 2019

NMPA (CFDA): These Cosmetic Devices Classified as Medical Equipment for the First Time

NMPA (CFDA) published the First Batch of Medical Device Classification Results on July 18. This document, classifying Class III (56 items), Class II (78 items), Class I (53 items) and […]
July 25, 2019

China UDI System: Cardiac Implants, Brain Implants and Prosthesis as First Trial

NMPA (CFDA) and National Health Commission announced the “Unique Device Identification (UDI) System Implementation Plan” on July 7. The NMPA UDI system has been established to “adequately identify medical devices […]