India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.

摘要

India's medical device regulatory landscape has undergone fundamental transformation over the past decade, with the Medical Device Rules (MDR) 2017 establishing the country's first purpose-built, risk-stratified regulatory architecture. This review examines that decade of reform to assess India's progress toward international regulatory harmonization and to identify priorities for further development. This structured narrative review traces legislative and institutional development from the Drug