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Current Regulatory Challenges and Approaches in Registering In-Vitro Diagnostics (IVD’s) in India

Author(s): Saminathan J* and Rashi Patel

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 to DCGI and approve products of IVD’s. The Schedule M-III and M-IV of D and C act 1940 and rules 1945 are led down, which provides information on quality management system and GMP practices and requirements of premises, equipment and plant for In vitro diagnostic reagents and kits respectively. Registration procedure of IVD’s, common submission format for registration, labelling requirements, regulatory scenario and recommendations to the government has been mentioned.


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