The article below provides comprehensive technical review on AI-aided Software Guideline, released in June 2019. It was written by Elisa Mark and published on BioWorld, a Hong Kong-based biotech magazine,
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support Order 739. Four supporting regulations
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway for clinical evaluation, which is
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
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
The 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 evaluations, and
ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA
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