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.

Abstract

Introduction: 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 developing effective global regulatory strategies.

Areas covered: PubMed and Embase databases were searched for relevant articles published over the past 20 years. The common ground and unique regulatory requirements for TPLC clinical evaluation of the NMPA, European Commission, and FDA were analyzed, with a particular focus on three premarket clinical evaluation strategies: clinical data or evaluation exemption, using existing clinical data, and generating new clinical data by conducting a clinical trial.

Expert opinion: Because of critical differences in regulatory requirements, the same clinical strategy may not be suitable for all three regulatory jurisdictions. When using the same premarket regulatory clinical evaluation approach, the time and cost investments for new product registration in the three regulatory jurisdictions could differ. A TPLC clinical evaluation strategy is critical for the time and cost assessment of a global regulatory strategy.