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Whether In-Vitro Diagnostic kits/reagents are regulated in India?
Yes, all In -Vitro Diagnostic kits/reagents are regulated in India under the provisions of the Medical Devices Rules, 2017.
Where can we get a copy of the Medical Devices Rules, 2017?
The copy of the Medical Devices Rules, 2017 is available in the CDSCO Website under the link: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf
Which division of CDSCO is responsible for review of IVD kits/ reagents ?
Medical Devices & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhavan, ITO, Kotla Road, New Delhi -110002.
11.Whether on market approved products, in India have to be newly registered as per Medical Devices Rules, 2017, when the existing license gets expired?
Yes, IVD products which are currently registered in India have to be registered according to the provisions of Medical Devices Rules, 2017.
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