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Indian & European Authorized Representative Services

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Indian and European Authorized Representative for Medical Devices Manufacturer

The EAR is a person/company that is appointed by the Indian Manufacturer who wants to CE Mark /Register/Sale their Medical Device in European Economic Region. Indian Manufacturers of Medical Devices who want Approval for Distribution of their Medical Device in Europe must appoint an European Authorized Agent / Representative.

Indian Authorized Agent for Foreign Medical Device Manufacturers

The Indian Authorized Agent is a person/company that is granted Power of Attorney by the Foreign Manufacturer who wants to Register/Sale their Medical Device in India. Foreign Manufacturers of Medical Devices who want Approval for Distribution of their Medical Device (Regulated Devices) in India must appoint an Indian Authorized Agent / Representative

As Indian Authorized Agent we can perform following responsibilities

Communicate between the Manufacturer and the Medical Devices Division of the CDSCO (Central Drugs Standard Control Organization).
Receiving Queries (If any) from the Competent Authorities during Registration and Collating the Necessary Documents to suit the Answers to all questions/ queries given by CDSCO.
Authorized Signatory on Your Behalf for all Legal Documents to be Submitted in CDSCO

As an Indian Authorized Agent we provide following service to our clients:

Collation of all necessary Documents and Process Applications to obtain Import Licenses (Form 10) for appointed distribution agents
Provide Information about Device Name and Address of Distributer in India on the request of CDSCO
If CDSCO selects your Company for Inspection; Our Experienced Professionals fully assist your Organization
Post Market Surveillance and Complaint Handling