Indian Authorised Agent for Overseas Medical Device Makers

An Indian authorised agent is the legal link between an overseas medical device or IVD manufacturer and CDSCO. The agent applies for the import licence, holds regulatory responsibility in India and handles post-market duties. Medfins International helps foreign manufacturers understand the role, choose the right agent structure, prepare the power of attorney and keep the arrangement compliant over time.

What is an Indian authorised agent?

Under the Medical Devices Rules, 2017, a foreign manufacturer cannot apply to CDSCO in its own name. It must appoint an Indian authorised agent, a company or firm in India that files the import licence application in Form MD-14, holds the resulting MD-15 import licence and answers to the regulator for the imported devices.

The appointment is made through a power of attorney from the manufacturer, supported by an undertaking from the agent in the format set out in the Fourth Schedule. The agent must itself hold a manufacturing licence, a wholesale licence or a registration certificate in Form MD-42.

Who needs an Indian authorised agent?

• Overseas manufacturers of medical devices and IVDs of any risk class seeking an MD-15 licence.
• Foreign companies that need a test licence in Form MD-17 to import samples for testing, evaluation or clinical investigation.
• Manufacturers changing distributors who want regulatory control separated from commercial distribution.
• Brands consolidating several Indian importers under one licence holder.

Responsibilities of the authorised agent

The Indian authorised agent is more than a filing address. In practice, CDSCO holds the agent accountable for:

Before approval

• Submitting a complete and truthful application with the manufacturer’s Device and Plant Master Files.
• Responding to CDSCO queries within the time allowed.
• Paying licence fees and keeping the application record.

After approval

• Ensuring only licensed devices from licensed sites are imported, with compliant labels.
• Maintaining distribution records so that products can be traced and recalled.
• Handling complaints and reporting adverse events under India’s materiovigilance programme.
• Notifying CDSCO of changes and paying the licence retention fee every five years.
• Cooperating with inspections and sampling by Medical Device Officers.

Choosing the right agent structure

Manufacturers usually choose between three models. Each has trade-offs in control, cost and flexibility.

• Distributor as agent: simple to set up, but the licence is tied to one commercial partner, which can make a later change of distributor slow.
• Own Indian subsidiary: full control and continuity, but requires setting up an entity, premises and a licence such as MD-42.
• Independent licence holder: a neutral, licensed Indian company holds the licence while several distributors sell. This separates regulatory and commercial roles.

The right answer depends on your product range, sales plan and how many partners you intend to work with. We help you weigh these options before any documents are signed.

Related roles in India

The CDSCO authorised agent should not be confused with other local representative roles. For example, a foreign manufacturer seeking a BIS licence under the Foreign Manufacturers Certification Scheme must nominate an Authorised Indian Representative for BIS purposes. The same Indian company can often fill several roles, but each has its own documents and obligations, and they should be planned together so that names, addresses and product lists stay consistent across regulators.

Documents required

• Power of attorney from the manufacturer naming the agent, the devices and the sites, authenticated as required (for example by apostille or through the Indian embassy).
• Undertaking by the Indian agent in the format prescribed in the Fourth Schedule.
• Copy of the agent’s wholesale licence, manufacturing licence or MD-42 registration.
• Constitution documents of the Indian entity and details of its premises.
• A written agreement defining responsibilities for vigilance, complaints, recalls and records.

Step-by-step process

1. Define scope: devices, sites and markets within India that the agent will cover.
2. Select the structure and verify that the proposed agent holds a valid licence.
3. Draft the power of attorney and undertaking; arrange legalisation in the home country.
4. Sign a quality or regulatory agreement covering post-market duties.
5. File the MD-14 application through the agent on the CDSCO online portal.
6. Operate and maintain: vigilance, record keeping, change control and renewals.

Timelines and what affects them

Setting up an agent arrangement can take anywhere from a few weeks to several months. The main variables are how long legalisation of the power of attorney takes in your country, whether the agent already holds a suitable licence, and how quickly both parties agree the division of responsibilities. Starting the power of attorney early is usually the single best way to save time. It also helps to prepare the Device Master File in parallel rather than waiting for the agent paperwork to be completed.

Common pitfalls

• Power of attorney that omits some devices or sites, forcing a fresh document later.
• Agent without a suitable licence, discovered only at filing.
• No written agreement on complaints and recalls, leaving gaps in vigilance reporting.
• Licence held by a distributor with no plan for what happens if the relationship ends.

How Medfins International supports you

Medfins International has worked with clients from more than 15 countries and holds its own CDSCO MD-42 registration, so we understand both sides of the agent relationship. Depending on your needs, we can:

• Advise on the most suitable agent structure for your plans in India.
• Draft the power of attorney, undertaking and regulatory agreement.
• Assess a proposed agent’s licence status and regulatory readiness.
• Prepare and file the MD-14 dossier and manage queries.
• Support the agent with post-market procedures and training.

If you also plan to sell to government hospitals, see our GeM registration service. To discuss your options, contact Medfins International.

Frequently asked questions