Abstract

A COMPREHENSIVE REVIEW ON REGULATORY AFFAIRS IN MEDICAL DEVICES

Ayeenedi Kusuma Lalitha*, Palaparthi Vasmitha and Ravula Tulasi Naga Pavan Kumar

ABSTRACT

Regulatory affairs play a crucial role in ensuring the safety, efficacy, and quality of medical devices. Regulatory frameworks vary across countries, with key agencies such as the U.S. FDA, the European Medicines Agency (EMA), and India’s Central Drugs Standard Control Organization (CDSCO) governing medical device approvals and compliance. This review provides an in-depth analysis of regulatory requirements, classification of medical devices, approval processes, and post-market surveillance across major global regulatos.

Keywords: Regulatory Affairs, Medical Devices, FDA, EMA, CDSCO, Medical Device Regulation, Approval Process, Post-Market Surveillance, Global Compliance, Clinical Trials, Technological Innovations.