ANSWERED ON THIS PAGE:
- Do foreign manufacturers need in-country representation in India?
- What are the responsibilities of the India Authorized Agent?
Medical device manufacturers without a legal entity in India must appoint an importer as an India Authorized Agent. The Authorized Agent is responsible for device registration and acts as a liaison between the manufacturer and the Central Drugs Standard Control Organisation (CDSCO), the country’s medical device regulator, and has many other responsibilities, as well.
India Authorized Agent qualifications, role and responsibilities
An India Authorized Agent is a local person or company responsible for a variety of tasks, including but not limited to the following:
- Submit all registration documentation to the CDSCO on your behalf.
- Act as the importer of the device on paper and manages importation and distribution in India.
- Serve as a regulatory liaison between you and the CDSCO.
- Oversee Serious Adverse Event (SAE) reporting for your device, if necessary.
- Assist with maintaining your device registration.
Once the CDSCO has approved your product, your Authorized Agent will hold your medical device registration in MD-15, known in India as an Import License.
Emergo by UL is an in-country representative with offices worldwide
We focus 100% on medical device and in-vitro diagnostic (IVD) regulatory issues, and your successful CDSCO registration is our goal. As your India Authorized Agent, we will act as your regulatory liaison with the CDSCO and fully manage your registration effort. Here is how we can help:
- Submit your medical device or IVD registration to the CDSCO.
- Administer all registration fees.
- Notify the CDSCO of any changes to your device.
- Coordinate adverse event reporting to CDSCO with you and your distributors.
- Support device recalls or field safety corrective actions (FSCA), if needed.
- Liaise between you and the CDSCO.
Common questions regarding the appointment of an India Authorized Agent for medical device companies
How can we transfer to a new authorized representative in India?
The regulations in India do not provide for the transfer of Authorized Agent responsibilities associated with a registered medical device. Manufacturers must have separate registrations for the same device for different distributors. Therefore, multiple registrations for the same device are possible.
Can we select more than one Authorized Agent?
If a manufacturer wishes to work with multiple importers in India, they can appoint multiple Authorized Agents, but each must obtain their own registration/Import License for the device. It is no longer possible to appoint an independent Authorized Agent other than the importer of the device, as only the Authorized Agent holding the registration may import products under the registration granted in its name.
How do we authorize the Authorized Agent?
The authorization granted by a manufacturer to its Authorized Agent must be documented by a power of attorney.
What are the requirements for an Authorized Agent?
India Authorized Agents require a Wholesale License for sale (20B/21B or renewal in 21C) or distribution of medical devices, or a Registration Certificate (MD-42) according to the provisions of Gazette Notification G.S.R. 754(E). They must also authenticate and register their firm or organization through the Online System for Medical Devices portal, after which they will have access to submit Import License (i.e., device registration) applications.