CRO Updates

May 30, 2018

Join Our Webinar: Key Ingredients for Effective China SDA(CFDA) CER and Clinical Trial

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

Concentrated Care in China Facilitates Clinical Trial Recruitment and Data Gathering

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

Highlights of CFDA’s Newly Released “Medical Device Clinical Trial Design Guidelines”

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

New Landscape of Medical Device Clinical Trial— CFDA’s Requirements for Accepting International Clinical Data

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

CFDA Issued Guideline for Clinical Evaluation of Proton/Carbon Ion Therapy System

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 […]