ISSN: 2642-6315
Authors: Priyadarshini B, Anushka S, Thatraju R, Anjana S and Manik G*
Any medical equipment must get a marketing authorisation from a regulatory authority before it can be sold. Obtaining authorization is a lengthy, multi-step process that requires relevant authorities to review material. After analyzing the information given by the Manufacturer, the concerned Regulatory authority provides marketing authorization. Manufacturers in the United States must apply to the US Food and Drug Administration for Marketing Authorization (USFDA). There are two types of applications in the United States: 510(k) and Pre-Market Application (PMA). The marketing of medical devices is permitted by national authorities in the EU. Notified Bodies (Third Parties) ensure Quality Assurance both before and after approval via third-party compliance. The sale and import of medical devices are approved by India’s Central Drugs Standard Control Organization (CDSCO). The CLAA scheme regulates medical devices. The central licensing authority for medical devices in India is the Drug Controller General of India (DCGI). This study aims to collect information on medical device regulations in three regions: the United States, the European Union, and India, and compare market authorization provisions in each region, as well as make this complex subject easier to understand for the readers. The medical device sector is made up of several different sorts of items that are used for a variety of purposes. Medical devices must be governed by tight rules according to the different risk categories since their safety and effectiveness are critical to human health. A common framework for medical device regulations is a comprehensive product life cycle regulatory system that includes product design, manufacture, premarket gatekeeping, and post market monitoring. Medical gadgets, on the other hand, are diverse and inventive, putting current regulatory systems to the test. As a result, competent authorities in charge of medical devices around the world are constantly updating their regulatory systems to ensure that medical devices are safe and effective. The goal of this study is to provide an overview of the regulatory regimes for medical devices in the United States.
Keywords: Medical Devices; Marketing Authorization; Classifications; Case Studies; Warning Letter, Effectiveness; Harmonisation
