Blogs

February 6, 2020

NMPA New Clinical Guidelines to be More Harmonized with International Standards

NMPA published the Technical Guidelines on Medical Device Clinical Evaluation (draft) on January 2, 2020 for feedback. The draft Guidelines consist of three documents: Clinical Evidence – Key Definitions and […]
February 5, 2020

Summary of NMPA Tumor Mutation Reagents Guideline

NMPA published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. Please see the summary below: Application […]
February 3, 2020

Two-Day to Get Emergency Approval: Combat China Novel Coronavirus

From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu provincial NMPA issued the Test […]
January 29, 2020

NMPA Finalizes Tumor Mutation Reagents Guideline for CDx

NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The draft guideline was issued on […]
January 29, 2020

Urgent Needs of Medical Products to Combat 2019 Novel Coronavirus

China national NMPA informed local NMPAs on Monday Jan 27 to allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan approval, to help conquer 2019 […]