June 27, 2018
Illustration of a laptop computer showing Grace Fu Palma speaking during a presentation for a webinar

Grace Palma, CEO of China Med Device, is interviewed by RAPS on China Medical Device Amendment

On June 25, China State Council released a draft amendment to overhaul the medical device regulations. On June 27, Grace Palma, CEO of China Med Device, is interviewed by Zachary Brennan, […]
June 26, 2018

Historical Medical Device Changes from NMPA (CFDA) Announced Today

The last time the NMPA (CFDA) “Medical Device Supervision and Management Regulations” were completely overhauled was in 2014 with a supplemental update in 2017. Today (June 25th, 2018) the new […]
June 25, 2018

CFDA Cracking Down on Labeling—36% Defects Have Labelling Issues

On June 22, CFDA published Quality Notice #47 and identified 64 defects for 9 types of medical devices: nerve and muscle stimulator, ultrasonic atomizer, disposable vaginal dilator, insulin pimp, oxygen […]
June 23, 2018

Weekly CFDA News Roundup (June 11th to June 18th) 

Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC ( […]
June 14, 2018

CFDA:Regulation Updates for Blood-Related Medical Device

This year, CFDA has issued 8 technical guidelines, 1 innovation approval and 1 class I recall for blood-related medical devices. Guideline: Technical Guideline on Continuous Glucose Monitoring Device; Technical Guideline […]