CURRENT REGULATORY REQUIREMENTS FOR MEDICAL DEVICES IN US, EU, AND INDIAAbstract
Clinical results of various medical treatments using medical devices demonstrate continuous advances, dealing with multiple types of products covering a vast range of applications in the last two decades. Millions of people rely on medical devices to diagnose and manage illnesses. A typical framework for medical device regulations is a whole product life cycle regulatory system that covers product design, production, premarket gatekeeping, and post-market monitoring. Nevertheless, the present regulatory frameworks are being tested by the diversity and innovation of medical devices. This comparative study serves as the basis for the research, which then examines the function of litigation in regulation and ensuring patient safety by placing medical device litigation within the context of the pertinent regulatory frameworks.
N. Suganthi, Kaviya Suresh and B. Anbarasan *
Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, SRIHER (DU), Porur, Chennai, Tamil Nadu, India.
12 January 2023
20 May 2023
31 May 2023
01 October 2023