CFDA Updates

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 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 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 16, 2017

Interpretation to CFDA’s Quality Management of Medical Device Clinical Trials

A. About the one-year validity period of the registration test report of medical device clinical trials Article 7 of the “Medical device clinical trial quality management practices” provides: “quality inspection […]