REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 4
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.
Authors and Affiliations
Rajkumar M. Gupta
Keywords
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