Medical device and IVD companies with devices that require registration in India must appoint an agent responsible for pre-certification and post-market surveillance inquiries. The Indian Agent must maintain a drug wholesale license and be a resident of India OR maintain a place of business there. Through our office in Secunderabad, Emergo can act as your India Authorized Agent.
Responsibilities of the India Authorized Agent representative.
The India Authorized Agent is a person/company responsible for device registrations, acting as the liaison between the manufacturer and the Medical Devices Division of the CDSCO (Central Drugs Standard Control Organization). Foreign manufacturers of medical devices that are on the list of regulated devices must appoint an Indian Authorized Agent.
In addition to being a resident of India, the India Authorized Agent representative must have prior experience in the industry, for example, as a medical doctor or pharmacist. 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 medical device registration documents and act as a point of contact for any inquiries related to the device 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.
Independent representation gives you full control over distribution.
Before selecting Emergo as their independent in-country representative, some clients have considered appointing a distributor to serve as their Agent. Distributors are happy to take on this role because they are fully aware that the appointed India Agent is tied to the medical device approval for its three year duration and responsible for obtaining licenses required for the importing process. That means if you appoint a distributor as your Indian Agent, you are “married” to them for at least three years. This can be problematic because if you decide to switch distributors because you will need to start the registration process over.
Emergo is a professional, independent in-country representative that specializes 100% in medical device regulatory compliance. Appointing us as your Indian Agent allows you to select and change distributors whenever you wish. As noted above, it is also important to understand that the India Authorized Agent is responsible for your medical device in India and therefore it is extremely important to be represented by a professional firm that specializes in regulatory issues and whose interests do not conflict with your company.
Tasks we perform as your India Authorized Agent
As your officially designated India Authorized Agent representative, Emergo will:
- Provide authorization to place the Emergo India name, mailing address and phone/fax numbers on your device submissions to the CDSCO
- Process applications to obtain Import Licenses (Form 10) for appointed distribution agents;
- Upon request by the CDSCO provide information about your medical device, and names and addresses of distributors established in India;
- Assist in coordination of an inspection if the CDSCO selects your company for an audit.
We are also available to perform a wide range of additional tasks such as post market surveillance including complaint handling, adverse incident reporting and product recall support. Emergo has been representing medical device and IVD companies since 1997 as a professional independent in-country representative and we are ready to act as your representative in India