The MedTech Rulebook: How India is Shaping the Future of Medical Device Governance
India’s medical devices sector is projected to grow from about $11 billion in 2020 to $50 billion by 2030.
A cardiac stent, a ventilator, an insulin pump, a diagnostic kit or an AI-enabled medical device may serve very different clinical purposes, but they share one reality: when technology enters healthcare, regulation becomes inseparable from patient safety. For India, this has made medical-device governance a strategic policy issue. The country wants to expand domestic manufacturing, attract investment, reduce import dependence and emerge as a global MedTech hub. At the same time, it must ensure that devices reaching patients are safe, effective and supported by credible evidence.
At the centre of this transition is the Medical Devices Rules (MDR), 2017.
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