Overview
Explore the implications of the Medical Device Rules, 2017 on the medical device industry in this comprehensive lecture. Gain insights into the regulatory framework governing medical devices in India, understanding how these rules impact manufacturers, importers, and distributors. Delve into key aspects of the legislation, including classification of medical devices, licensing requirements, quality management systems, and post-market surveillance. Learn about the changes brought about by these rules and their significance for ensuring safety, efficacy, and quality of medical devices in the Indian market. Analyze the challenges and opportunities presented by the new regulatory landscape, and discover how industry stakeholders can navigate compliance requirements effectively.
Syllabus
Medical Device Rules, 2017: Implications on medical devices
Taught by
NPTEL-NOC IITM