India Authorized Agent Representative for medical device Companies
Entellus Food & Drugs Regulatory Service representing medical device companies with no registered location in India must appoint an agent responsible for pre-certification and post-market surveillance inquiries. The Indian Agent must be a resident of India OR maintain a place of business there. Our office in Delhi (India), Entellus FDRS Pvt. Ltd. can act as your India Authorized Agent.
Responsibilities of the India Authorized Agent representative
The India Authorized Agent is a person/company responsible for Product registrations, acting as the liaison between the manufacturer and the CDSCO (Central Drugs Standard Control Organization). Foreign manufacturers of Products that are on the list of regulated products must appoint an Indian Authorized Agent.
The India Agent has significant responsibilities and is also legally liable for the product in India. The extent of responsibility is very different from the role of the "US Agent" representative required by the United States FDA. The India Authorized Agent is granted, through Power of Attorney by the manufacturer, authorization to submit Product registration documents and act as a point of contact for any inquiries related to the Product by the CDSCO. The Agent is also involved in vigilance activities and acts on the manufacturer’s behalf if an onsite inspection of the manufacturer’s facility is required.