Authors
Neha Kamble, Prajkta Balakshe, Atish Velhal
Published in
Expert review of medical devices. Oct 06, 2026. Epub Oct 06, 2026.
Abstract
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 five years should bring India's framework into closer alignment with IMDRF reference members.
PMID:
42834824
Bibliographic data and abstract were imported from PubMed on 06 Oct 2026.
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