CFDA Updates

August 27, 2017

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

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 […]
August 27, 2017

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

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 […]