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

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 Drugs and Cosmetics Act 1940 through five MDR 2017 amendments to 2024, benchmarks India's framework against the US FDA, EU MDR 2017/745, and the WHO Global Model Framework across ten regulatory domains, and assesses the regulatory-industrial nexus through the PLI scheme, Medical Device Parks, and NMDP 2023. A structured search of PubMed, ScienceDirect, and SpringerLink (2014-2024) was supplemented by gazette notifications, CDSCO guidance, and ministry and parliamentary publications.

India's reforms have generated measurable advances in device quality, patient safety, and affordability, positioning the framework substantively - though not fully - on par with leading global regulators, with persisting gaps in enforcement capacity, AI/ML governance, and device-data integration. Closing these gaps over the next 5 years should bring India's framework into closer alignment with IMDRF reference members.