CFDA Updates

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), […]
August 1, 2018

CFDA New Medical Device Classification Catalogue Effective August 1st, 2018

CFDA Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the […]
July 31, 2018

Overseas Inspection: There are Defects CFDA Chasing

Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24 […]