Pharmaceutical Regulatory Affairs: Open Access

Harvinder Popli

Publications

• Review Article
  Medical Devices Regulation in United States of America, European Union and India: A Comparative Study
  Author(s): Rohin Sethi, Harvinder Popli and Sunit SethiRohin Sethi, Harvinder Popli and Sunit Sethi
  
  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 .. Read More»
  DOI: 10.4172/2167-7689.1000179

  Abstract PDF