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.
Enter your contact information below and a member of our team will reach out to you shortly.
DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.