Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle.

초록

The China National Medical Product Administration (NMPA), European Commission, and United States Food and Drug Administration (FDA) follow similar principles to establish regulatory requirements for medical device clinical evaluations throughout the total product lifecycle (TPLC). However, critical differences in these requirements may have led to different regulatory clinical evaluation strategies in the three jurisdictions. A thorough understanding of these differences is crucial for developin