Reach Us +447480022765
Centre for Drug Regulatory Affairs, Delhi Pharmaceutical Sciences and Research University, Delhi, India

Publications

  • Reviews   
    Current Regulatory Challenges and Approaches in Registering In-Vitro Diagnostics (IVD’s) in India
    Author(s): Saminathan J* and Rashi Patel

    Abstract

    The quality of medical devices is governed by regulatory authorities of the respective countries. The regulations are intended to protect the risks associated with design, manufacture and packaging of medical devices. India is one of the top twenty markets for medical devices in the world and the fourth largest market in Asia. The National Medical Device Policy 2015 is framed out by the Government of India to strengthen the medical device market and decreasing dependence on importing the medical devices. In vitro diagnostic (IVD’s) are used for the invitro examination of specimens derived from the human body solely or principally to diagnose the problems. The Indian medical device sector is about USD 4.9 billion in which of 53% are IVD’s. The in-vitro diagnostic advisory committee (IVDAC) is prepared by Government of India to give advice in matters related to IVD’s t.. Read More»