CFDA Updates

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 […]
August 28, 2017

CFDA’s Approval Of Gilupi’s CellCollector for In-Vivo CTC Isolation Signifies The Importance of Partnership Between International Medical Device Manufacturers and Chinese Local Firms

CFDA’s Approval Of Gilupi’s CellCollector for In-Vivo CTC Isolation Signifies The Importance of Partnership Between International Medical Device Manufacturers and Chinese Local Firms To enter the Chinese market, partnership forged […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 4 of 4)

The Review and Approval of Innovative Medical Devices   In 2016, China Food and Drug Administration received a total of 197  applications for  approval of innovative medical devices, organized expert […]