May 30, 2018
Which is your clinical pathway in China, CER or Clinical Trials? How to get oversea clinical data accepted by China SDA? How can you use CFDA unapproved device in China […]
March 19, 2018
Source: New York Times China does not have a distributed primary and community-based network of healthcare. The picture here may make you think Chinese are waiting in line for football […]
January 29, 2018
On January 8th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document. In this guidelines […]
January 22, 2018
On January 11, 2018, the CFDA issued a guideline for accepting medical device international clinical trial data. This new guideline could benefit foreign medical device manufacturers by facilitating their clinical […]
January 17, 2018
This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the clinical evaluation data that may […]