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, DKNSB 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.

Please ask for Quotation

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