Pharmaceutical Regulatory Affairs: Open Access

Overview of Current Regulations Governing Medical Devices

Abstract

George B

Medical Device (MD) is one of the fastest growing sectors and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Understanding and interpreting the global MD evolving regulations and requirements is important (for not just the manufacturers, importers, wholesalers and distributors but even the clinicians) in the current global competitive market. This review is an attempt to do that by giving an overview of the prevailing MD regulations in United States (US), Europe and India.