CFDA Updates

August 29, 2018

CFDA: 99 Device Standards to be Revised in 2018 – Huge Impact on Renewals and New Registrations

CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is the finalized version of the […]
August 27, 2018

2nd Round UDI Feedback Requested By CFDA

CFDA announced Unique Device Identification (UDI) draft plan for feedback on August 22, to adequately identify medical devices through their distribution and use. When fully implemented, the label of all […]
August 17, 2018

In One Day, 17 Industry Standards Released by CFDA

On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables. 1.       Test methods for packaging of sterilized medical devices: Breathable […]
August 16, 2018

Major Leadership Demotion at CFDA Today

3 CFDA  national leaders and 7 provincial leaders have been demoted as a result of the recent vaccines poor quality incident for  the oversight over the substandard vaccines manufactured by […]
August 10, 2018

Monthly CFDA News Roundup (July)

Monthly 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), […]