The Central Drugs Standard Control Organization (CDSCO) stands as the vigilant gatekeeper of India’s booming medical device market. Governed by the stringent Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, CDSCO’s mandate is clear: ensure every medical device entering or manufactured in India meets the highest global benchmarks for safety, quality, and efficacy.

For global and domestic innovators, navigating CDSCO’s intricate regulations – from precise device classification and exhaustive documentation to mastering the CDSCO Sugam portal and adapting to evolving guidelines – can be the most significant barrier to market entry and growth.

This is where MDR Consultants redefines the journey.

We don’t just guide you through compliance; we fast-track your success. Our deep-seated expertise and strategic insights cut through complexity, transforming regulatory hurdles into streamlined pathways. With MDR Consultants, your devices achieve rapid, confident, and enduring market access.