Introduction to the Regulation of Medicines and Medical Devices Health Essay
Review article Open Access. Overview of current regulations regarding medical devices. Bobby George Vice President and Group Head of Regulatory Affairs, Reliance Life Sciences Pvt. Ltd, Navi, The Medicines and Healthcare products Regulatory Agency, MHRA has produced an introductory guide to ensure manufacturers are aware of their obligations under the new EU medical regulations. The past decade has witnessed an explosion in the variety, use and complexity of medical devices. The US Food and Drug Administration (FDA) is charged with ensuring the safety and effectiveness of medical devices in the United States and regulates more types of devices and device models. Until the government regulated categories of medical devices as drugs, see the list of categories of medical devices. medical devices at the end of the article. The government then exercised its powers to declare and actually report one or more categories of medical devices as 'medicine'. Part I, AI and Data as Medical Devices, introduced by W. Nicholson Price II, focuses on what is perhaps the most exciting and hot topic in the field of medical device regulation. These chapters explore the digital healthcare revolution and regulators' struggle to keep pace with the changing medical products landscape.