Medical Devices Regulation in United States of America, European Union and India: A Comparative Study
Rohin Sethi*, Harvinder Popli and Sunit Sethi
Department of Drug Regulatory Affais, Delhi Pharmaceutical Science and Research University, Delhi, India
- *Corresponding Author:
- Rohin Sethi
Department of Drug Regulatory Affais
Delhi Pharmaceutical Science and Research University, India
E-mail: [email protected]
Received date: January 09, 2017; Accepted date: January 16, 2017; Published date: January 24, 2017
Citation: Sethi R, Popli H, Sethi S (2017) Medical Devices Regulation in United States of America, European Union and India: A Comparative Study. Pharm Regul Aff 6:179. doi:10.4172/2167-7689.1000179
Copyright: © 2017 Sethi R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
In order to market any medical device, marketing authorization from Regulatory authority is required. The process of gaining authorization is complex, multistep and requires review of information by competent authorities. Upon scrutinizing the information furnished by Manufacturer, marketing authorization is granted by the concerned Regulatory authority. In the USA, manufacturers are required to apply to United States Food and Drugs Application (USFDA) for Marketing Authorization. There are two types of applications in USA; 510 (k) and Pre-Market Application (PMA). In EU, National Authorities give approval for marketing medical devices. A system of third party compliance is followed, where Notified Bodies (Third Party) ensure Quality Assurance, pre and post approval. In India, Central Drugs Standard Control Organization (CDSCO) approves devices for sale and import. Medical Devices are regulated under CLAA scheme. The Drug Controller General of India (DCGI) is the central licensing authority for medical devices. This paper attempts to capture information on regulations of Medical Device in three regions namely; USA, EU and India and compare provisions of Market authorization in the respective regions, and further, for the readers, make this complex subject easier to grasp.