Blogs

August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 1 of 4)

1. The Work on Medical Device Registration (a) The gradual improvement of medical device registration management regulatory system The issue of the ” Quality Management Practices of Medical Device Clinical […]
August 24, 2017

Vixiar Medical Raised a $1.5 Million Seed Round

Vixiar Medical, a spin-off from Johns Hopkins, recently completely its seed round funding.  The USD $1.5million investment was provided by the Abell Foundation and TEDCO, as well as Kacero Holdings, […]
August 22, 2017

CFDA Released the “Conditions and Filing Management Measures of Medical Device Clinical Trial Sites

In accordance with the requirements of “the Decision on the Revision of the Medical Device Supervision and Management Regulations” issued by on State Council of P. R. China, the qualification […]
August 22, 2017

CFDA Issued New Techinical Review Guidelines on Detal Implant Equipment and Soft Contact Lens

2 new guidelines have been released by CFDA on August 9th. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in […]
August 21, 2017

A US Company Taps Into China’s Market with With Its Skin-Treatment Technology

A US Company Taps Into China’s Market with With Its Skin-Treatment Technology Sensus Healthcare, a Boca Raton Fla. medical device maker,  has been cleared by CFDA to expand its operations in […]