Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization.

Abstract

The medical device industry has experienced a significant upsurge in the number, diversity, and complexity of devices over the last two decades. As the global demand for medical devices grows, regulatory frameworks across major economies, including the USA, Europe, India, China, and Australia, have evolved to ensure safety, quality, and efficacy. This review critically examines the regulatory guidelines for medical devices across these regions, emphasizing the need for harmonization to streamlin