GLOBAL PERSPECTIVES ON MEDICAL DEVICE REGULATIONS: A COMPARATIVE STUDY OF US, CANADA, EUROPE, INDIA, AND JAPAN

This review paper compares medical device regulations across the United States (US), Canada, Europe, India, and Japan. It offers an understanding of the many regulatory frameworks that control the approval processes for medical devices, the Competent Authorities, the rules and regulations, the licensing or registration processes, the classification systems for devices, and the quality management/GMP standards. The US adheres to rigorous approval procedures, encompassing quality system regulations and stringent reporting standards. Health Canada’s regulatory system entails pre-market scrutiny, post-market surveillance, and compliance measures. India’s regulatory landscape requires urgent enhancements to streamline guidelines and implementation strategies. In the European Union (EU), products must meet essential conditions to obtain CE marking for market entry. Japan employs the PMDA & MHLW for safety reviews, approvals, and post-market monitoring. This comparative study underscores the importance of harmonizing global regulatory standards and highlights areas for future improvement. This study outlines key findings and implications, serving as a valuable resource for stakeholders navigating international medical device regulations.