PubMed

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

PMID: 42834824 · 2026-10-06

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ЖурналExpert review of medical devices

Год2026-10-06

PMID42834824

Аннотация

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

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