TEXTBOOK OF REGULATORY ASPECTS OF MEDICAL DEVICES

This Textbook is designed to impart the fundamental knowledge on the medical devices and in
vitro diagnostics, basis of classification and product life cycle of medical devices, regulatory
requirements for approval of medical devices in regulated countries like USFDA, EMA and
ASAIN countries along with WHO regulations. It prepares the students to learn in detail on the
harmonization initiatives, quality and ethical considerations, regulatory and documentation
requirements for marketing medical devices and IVDs in regulated country and global level.