Clinical Evaluation

February 26, 2021

Imaging Ultrasonic Diagnostic Equipment Clinical Guideline Issued by NMPA

NMPA published “Clinical Evaluation Guideline on Medical Imaging Ultrasonic Diagnostic Equipment with the Same Variety” on January 19, 2021. The 27-page document provides manufacturers detailed pathway for clinical evaluation, which […]
February 26, 2021

More Information Released on the Pilot Trial in Greater Bay Area

Before July 21, 2021 the devices and drugs from Hongkong and Macao public hospitals can be clinically used in a Shenzhen Hospital, according to a joint announcement by Guangdong NMPA […]
February 18, 2021

16 Class III Devices Exempted from Clinical Trial

NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluation, and to […]