REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA

  • Rajkumar M. Gupta

Abstract

Marketing authorization of medical devices in India is given under heading “Registration Certificate and it is as per the regulatory processes in other countries. The foreign companies marketing of medical devices require either own office or an agent to receive, store and distribute the devices. The marketing Authorization (Registration Certificate) is considered valid for three years from the date of its issue. Only the Notified Medical Devices, New medical Devices and the devices classified under drug rules require marketing Authorization from DCGI. The other medical devices e.g. Non-notified devices do not require manufacturing, sales, import registration and can be marketed freely.

Keywords: CDSCO, FDA, Medical devices, DCGI.

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References

1. Medical Device Division, Guidance Document [Internet]. CDSCO New Delhi, India; 2014 March [cited 2014 April 22]. Available from:
www.cdsco.nic.in/Medical_div/guidance.htm
2. Medical Device Division [Internet]. CDSCO New Delhi, India; 2014 March [cited 2014 April 24]. Available from:
http://cdsco.nic.in/Medical_div/medical_device_division.htm
3. Medical devices and diagnostics - Central Drugs Standard [Internet]. CDSCO New Delhi, India; 2014 [cited 2014 May 03]. Available from:
www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1
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How to Cite
Gupta, R. M. “REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 4, Feb. 2018, pp. 25-32, doi:10.22270/ijdra.v2i4.150.