CFDA Updates

September 11, 2017

CFDA Update: iCAD’s Xoft Axxent Balloon Applicators Approved for Early-Stage Breast Cancer

CFDA UPDATE CFDA Update: CFDA has approved iCAD Inc.’s Xoft Axxent balloon applicators for the treatment of early-stage breast cancer. This approval makes the complete suite of Xoft System products […]
September 7, 2017

CFDA Released 4 Industry Standards for Medical Devices

CFDA recently issued the No. 99 Announcement of 2017, which issued YY / T 1574-2017 “The guide of the alginate gel fixation or microencapsulation of the tissue engineering medical device products” and other […]
September 7, 2017

CFDA announced the new “Medical Device Classification Catalogue”!

On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory has significant implications for medical […]
September 7, 2017

Our CEO, Grace Fu Palma, Will be Speaking on 2017 RAPS Regulatory Convergence!

China Med Device, LLC Founder and CEO, Grace Fu Palma, will be speaking on CFDA approval and updates at the upcoming 2017 RAPS Regulatory Convergence in DC.  Ms Palma, a […]
September 1, 2017

CFDA Updates: Notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.

On August 8th, CFDA issued a drafted notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”. In this […]