If you have no local presence in India and your medical device or IVD appears on the list of Notified Medical Devices and IVDs requiring registration, you are required by the Central Drugs Standard Control Organization (CDSCO) to appoint an India Authorized Agent to serve as your in-country representative.
India Agent responsibilities and requirements
Your India Authorized Agent is responsible for assisting with the device registration process and serves as a liaison between you and the Medical Devices Division of the CDSCO. The Agent is also involved in vigilance activities and will facilitate communication if an onsite inspection is required.
The Indian Agent must maintain a drug store license (Forms 20B and 21B/C) and be a resident of India or maintain a place of business there. Additionally, your appointed Agent must have prior experience in the industry (such as a medical doctor or pharmacist).
Independent representation gives you full control over distribution
Your appointed India Agent is tied to the medical device approval and is responsible for obtaining licenses required for the importing process. If you appoint a distributor as your India Authorized Agent, you are essentially “married” for the duration of the three year approval. This can be problematic if you decide to switch distributors, as transfers are not allowed and you would have to start the registration process over.
For this reason, we suggest choosing an independent in-country representative, rather than a distributor. Appointing an independent India Agent gives you the freedom to select and change distributors whenever you wish.
Read more about the benefits of hiring an independent firm to act as your India Agent.
Why you should appoint Emergo as your India Authorized Agent
With staffed offices in India, Emergo specializes 100% in medical device regulatory compliance and can act as your independent India Authorized Agent. If selected as your India Agent, we will:
- Serve as a point of contact for any inquiries from the CDSCO related to your device
- Assist in the coordination of an inspection if the CDSCO selects your company for an audit
- Assist with post-market surveillance including complaint handling, adverse incident reporting and product recall support
- Process applications to obtain Import Licenses (Form 10) for appointed distribution agents
- Provide information about your medical device, along with names and addresses of distributors established in India, if requested by CDSCO