August

August 30, 2017

A Shanghai JV Is Created To Invest In International Medical Device Companies

A Shanghai JV Is Created To Invest In International Medical Device Companies The Trendlines Group is an Israeli medical technology incubator that focuses on developing and commercializing medical and agricultural […]
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

To enter the Chinese market, partnership forged between international medical device manufacturers and local Chinese firms is on the rise. In such partnership, the medical device companies are working with […]
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 to […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 3 of 4)

1. The Review and Approval of Medical Device Registration Applications In 2016, China Food and Drug Administration completed a total of 9336 technical reviews of medical device registration applications. Compared […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 2 of 4)

B. The Acceptance Of Medical Device Registration Application In 2016, China Food and Drug Administration received a total of 8920 applications for medical device registration, renewal of registration and licensing […]
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 […]
August 18, 2017

More Coordinated Efforts Between US FDA and China’s CFDA On ICH

More Coordinated Efforts Between US FDA and China’s CFDA On ICH On August 9, 2017, in an FDAVoice blog post, Theresa M. Mullin, director of FDA’s Office of Strategic Programs […]
August 17, 2017

China’s Orthopaedics Market Is Growing Fast

Recent market report by BIS Research: China’s orthopaedics market is growing fast. The orthopaedic devices market is rapidly growing. Hospitals, specialty clinics and other end users are extensively adopting various devices, […]