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
