Registration in India
Access to the Indian market
Foreign manufacturers seeking to register a medical device in India must appoint a local Indian agent to handle the application with the Central Drugs Standard Control Organisation (CDSCO).
The procedure includes submitting an import license application along with supporting documents such as the Device Master File (DMF)and Plant Master File (PMF). Following CDSCO review and any potential inspection, an import license is issued, with timelines varying depending on the device class.
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