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.

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.

Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices.

Introduction: Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative.

Areas Covered: We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices.

Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies.

Introduction: The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre-market and post-approval clinical evaluation (CE) strategies.

Areas Covered: We aimed to investigate the 3-stage evolution of NMPA regulatory guidance on MDCE (1. The era before specific CE guidance, 2.