Vice President & Group Head Regulatory Affairs, Reliance Life Sciences Pvt. Ltd, Navi Mumbai, Maharashtra, India
*Corresponding author Tel.: +91-7738385697; E-mail address: bobby.george@relbio.com (B. George).
Online published on 17 September, 2019.
Medical Device (MD) is one of the fastest growing sector 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 (U.S), Europe and India.
Medical Device, Center for Devices and Radiological Health, 510(k), CE mark, FDA, CDSCO
