REGULATORY ASPECTS OF MEDICAL DEVICES

Regulatory Aspects of Medical Devices is a comprehensive textbook designed for M.Pharm Regulatory Affairs (MRA) students, pharmacy professionals, researchers, and regulatory specialists. The book provides an in-depth understanding of global medical device regulations, covering risk-based classification, IMDRF, GMDN, STED, ISO 13485, ISO 14971, clinical investigations, quality systems, post-market surveillance, and regulatory frameworks of India, USFDA, European Union, ASEAN, China, and Japan. Featuring comparative tables, practical regulatory insights, and examination-oriented content, it bridges academic learning with industry requirements. This essential guide equips readers with the knowledge needed to ensure compliance, support product approvals, and build successful careers in the medical device regulatory sector.