CFDA Updates

July 3, 2018

Monthly CFDA News Roundup (June 2018)

Monthly CFDA News Roundup covers policies, government reports, 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 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 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) […]