Blogs

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 17, 2018

Problems and Suggestions for Medical Device Clinical Auditing in China

In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions.   Clinical […]
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 12, 2018

Introduction of CFDA Approved Combination Products

In 2017, CFDA announced the first batch of approved combination products in China In 2017, CFDA announced the first batch of approved combination products since the release of the combination […]