CFDA Updates

June 26, 2018

Historical Medical Device Changes from SDA (CFDA) Announced Today

Skyline of the Huangpu River and the Lujiazui Financial District in Pudong, Shanghai, January 13, 2018. [Photo/IC] The last time the SDA (CFDA) “Medical Device Supervision and Management Regulations” were […]
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 (www.ChinaMedDevice.com) […]
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 […]
June 13, 2018

Weekly CFDA News Roundup (June 3rd to June 10th)

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 (www.ChinaMedDevice.com) […]