India Revamps Medical Device Regulations

India is revising its medical device regulations under the Medical Device Rule (MDR), 2017, with the Central Drugs Standards Control Organization (CDSCO) classifying 1,178 devices into four risk-based categories. This aims to enhance oversight and safety while streamlining approvals through State Licensing Authorities. India's medical device market, currently valued at billion, is projected to grow to billion by 2030. Challenges include reliance on imports and limited domestic production. Government initiatives like a ₹500 crore scheme for manufacturing and reforms in certification are expected to boost the sector, ensuring safety, innovation, and economic growth in healthcare.