Regulatories

Overview

A manufacturer who is willing to market their Medical Device in Indian market, may often has to designate a local authorized representative or in-country representative, if they do not have a registered place of business in the targeted country.

A Medical Device authorized representative is any natural or legal person having a local entity in the territory, who is explicitly designated by the manufacturer, acts and may be addresses the authorities and bodies in the country on behalf of the manufacturer.

The common responsibilities of an authorized representative include:

REGULATORY SERVICES IN INDIA

CE MARKING, USFDA, WHO, HEALTH CANADA

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