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

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 […]
July 23, 2019

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 […]