A foreign medical device manufacturer cannot hold an Indian import licence directly. The licence is applied for, and held, by an Indian Authorised Agent. That single structural fact has more commercial consequences than most manufacturers realise when they sign their first agreement.
This guide explains what an Indian Authorised Agent is under the Medical Devices Rules 2017, who can legally act as one, what they are liable for, and the choice that most often traps manufacturers later.
What is an Indian Authorised Agent?
Under the Medical Devices Rules 2017, a manufacturer located outside India that wishes to import a medical device or IVD must act through an Indian Authorised Agent — an entity established in India, holding an appropriate licence, formally appointed by the manufacturer to represent it before the Central Drugs Standard Control Organisation (CDSCO).
The Authorised Agent is the applicant. The import licence issued in Form MD-15 is granted in the name of the Authorised Agent, referencing the foreign manufacturer and the devices concerned.
This is the point to sit with. You do not own the licence. Your agent does.
Who can act as an Indian Authorised Agent
Not any Indian company can take the role. The agent must hold a valid licence permitting the sale and distribution of medical devices in India — in practice a wholesale licence, or a manufacturing licence issued under the Medical Devices Rules 2017.
The manufacturer must also grant a formal Power of Attorney, executed and notarised, authorising the agent to act on its behalf before the licensing authority.
The pathway: MD-14 to MD-15
- Classify the device under the Medical Devices Rules 2017 — Class A, B, C or D, based on risk. Classification determines the fee, the evidence and the review route.
- Appoint the Authorised Agent and execute the Power of Attorney.
- Compile the dossier — free sale certificate, ISO 13485 certificate, CE certificate or 510(k) clearance where applicable, plant master file, device master file, labelling, IFU and the manufacturer’s regulatory history.
- File Form MD-14 through the SUGAM portal with the prescribed government fee.
- Respond to CDSCO queries. Nearly every application receives them. Response quality and speed determine the timeline more than anything else.
- Receive Form MD-15, the import licence.
The MD-15 licence remains valid provided the licence retention fee is paid before the completion of each five-year period and the conditions of the licence continue to be met. Missing the retention payment can cause the licence to lapse — and recovering from a lapse is considerably harder than maintaining one.
What the Authorised Agent is actually liable for
The role is not administrative. Under the Medical Devices Rules 2017 and the Drugs and Cosmetics Act, the Authorised Agent carries substantive legal responsibility:
- Regulatory compliance for the imported devices, including labelling and conditions of the licence
- Product recall — the authority and obligation to recall devices from the Indian market
- Vigilance and adverse event reporting under the Materiovigilance Programme of India
- Facility inspections — representing the manufacturer where the licensing authority inspects
- Post-approval changes — filing variation applications for new models, sites or entity changes
- Record keeping and production of documents on demand
An agent who does not understand these duties is a liability to you, not a convenience.
The mistake that costs manufacturers their market
The most common structural error is appointing your Indian distributor as your Authorised Agent.
It feels efficient. One relationship, one contract, one point of contact. And for as long as the commercial relationship works, it is fine.
The problem appears when it stops working. Because the MD-15 licence is held in the distributor’s name, ending the distribution agreement can mean:
- You lose the import licence attached to your devices
- A new agent must apply again from the beginning, with fresh fees and fresh timelines
- Your product is off the Indian market during that gap
- Your former distributor retains a licence referencing your devices, and commercial leverage you did not intend to give them
We have been brought in to unpick this situation more than once. It is recoverable, but it costs months of market absence that a different structure at the outset would have avoided entirely.
The alternative: an independent Authorised Agent
Separating the regulatory role from the commercial one keeps the licence with a neutral party whose only interest is your compliance. You can then appoint, change or run multiple distributors without touching your licence.
For manufacturers who expect their Indian distribution to evolve — which is most — this is the more durable structure. See our Indian Authorised Agent services for how we hold this role.
How to evaluate an Authorised Agent
- Does it hold a valid wholesale or manufacturing licence? Ask to see it. This is a legal precondition, not a formality.
- Is it independent of your distribution? If not, understand exactly what happens to the licence if the commercial relationship ends, and put it in writing.
- Can it handle CDSCO queries technically? Query responses are regulatory documents. An agent that forwards them to you and waits is adding delay, not value.
- Does it have a vigilance process? Adverse event reporting has defined timelines.
- What happens on exit? Agree the transfer mechanism before you sign, not when you need it.
Documents a foreign manufacturer typically needs
- Power of Attorney to the Authorised Agent, notarised and apostilled
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certificate
- CE certificate, US FDA 510(k) clearance or other regulatory approvals held
- Plant Master File and Device Master File
- Labels, instructions for use and packaging artwork
- Undertaking regarding conformity to standards and regulatory history
How Medfins International acts as your Indian Authorised Agent
We hold the Authorised Agent role independently of distribution. That covers device classification under the Medical Devices Rules 2017, dossier compilation and Form MD-14 filing through SUGAM, CDSCO query management, grant and maintenance of the Form MD-15 licence, licence retention and variation filings, vigilance and adverse event reporting, and representation during inspections.
Because we do not distribute, your commercial arrangements stay entirely yours.
Frequently asked questions
Can a foreign manufacturer hold an Indian import licence directly?
No. Under the Medical Devices Rules 2017 a manufacturer outside India must act through an Indian Authorised Agent holding a valid wholesale or manufacturing licence. The Form MD-15 import licence is granted in the name of that agent.
Who can be an Indian Authorised Agent?
An entity established in India holding a valid licence to sell or distribute medical devices — typically a wholesale licence — or a manufacturing licence issued under the Medical Devices Rules 2017, formally appointed by the manufacturer through a notarised Power of Attorney.
What is the difference between Form MD-14 and Form MD-15?
Form MD-14 is the application for an import licence, submitted by the Authorised Agent through the SUGAM portal. Form MD-15 is the import licence itself, granted by the Central Licensing Authority once the application is approved.
Can I change my Indian Authorised Agent?
Yes, but it is not automatic. Because the licence is held in the agent’s name, changing agents generally requires a fresh application by the new agent, and cooperation from the outgoing one. This is why the appointment decision matters far more than it first appears, and why separating the regulatory role from distribution is worth considering at the outset.
Should my distributor be my Authorised Agent?
It is permitted, and it is common, but it concentrates commercial and regulatory control in one party. If the distribution relationship ends, the import licence sits with your former distributor and your product can be off the market while a new agent reapplies. Many manufacturers prefer an independent agent for this reason.
How long is a Form MD-15 licence valid?
The import licence remains valid provided the licence retention fee is paid before the completion of each five-year period and the conditions of the licence continue to be met. Failure to pay on time can cause the licence to lapse.
Entering the Indian market?
If you are appointing an Authorised Agent for the first time, or you are locked into a distributor-held licence and want to understand your options, we can walk you through the structure and what changing it would involve.
Write to sales@medfinsinternational.com or call +91 8527048221.