Comparative Study of Indian Medical Devices Regulations with Selected Countries: A Systematic Review

Abstract

The global medical device industry has seen significant growth in recent years, highlighting the need for coherent and harmonized regulatory frameworks. India, recognizing this demand, introduced the Medical Devices Rules (MDR), 2017 under the Drugs and Cosmetics Act, 1940 to enhance safety, effectiveness, and quality of medical devices. This paper compares India's evolving regulatory system with six established regimes: those of the USA, UK, EU, Canada, Australia, and Japan. Key aspects examined include device classification, approval pathways, Quality Management Systems (QMS), clinical evidence requirements, labeling, unique device identification (UDI) implementation, regulation of software as medical devices (SaMD), and post-market surveillance. While India’s framework exhibits strengths—such as adopting a risk-based classification system and initiating regulatory capacity-building—challenges remain in areas like innovation, facilitation and technical infrastructure. The study concludes with policy suggestions to strengthen India's regulatory ecosystem and support its ambitions to become a global hub for medical devices.