Indian Authorized Agent (IAA) for Medical Device Import

CDSCO compliant local representation for foreign manufacturers entering India, including Form MD-14 / MD-15 medical device import license India approvals. Morulaa is India’s biggest Indian Authorized Agent (IAA) (by SKUs represented) for foreign medical device manufacturers. We provide IAA services for over 2000 SKUs as of 2026. We are the only Indian Authorized Agent in India’s top 10 most represented manufacturers by unique MD-15 import licenses (as of 2026).

As a foreign medical device manufacturer, you cannot import or sell your devices in India without designating an Indian Authorized Agent (IAA), also known as a CDSCO Agent. While domestic companies apply for a medical device manufacturing license India route, foreign manufacturers must designate an IAA for imports.

A CDSCO compliant Indian entity must be your local partner for regulatory documentation and legal compliance with the Medical Device Rules, 2017.

Morulaa provides IAA services and regulatory support to medical device manufacturers, including assistance with import licensing (Form MD-14 and Form MD-15) at the level of national distributorships typically accessed by larger medical device companies.

Why Manufacturers Choose Morulaa as Their Indian Authorized Agent (IAA)

When choosing an IAA, foreign manufacturers typically seek partnerships with entities that have the resources of manufacturer level distributorships:

• India’s largest IAA by SKUs represented (as of 2026)

• Over 2000 SKUs under IAA representation

• Only IAA in India’s top 10 manufacturers by unique MD-15 import licenses (as of 2026)

• One stop service for IAA, registration pathway, labeling, and post market support

This combination allows you to enjoy the benefits of an IAA with the scope of services usually found at the level of manufacturer representatives.

What Is an Indian Authorized Agent (IAA)?

An Indian Authorized Agent is a local entity that can represent a foreign medical device manufacturer before the Central Drugs Standard Control Organisation. An IAA can file applications, receive communication from CDSCO, and provide licensing and post market support to manufacturers.

In practice, foreign medical device manufacturers usually seek a single entity that can act as an IAA while also guiding them through the medical device approval process in India and import licensing (Form MD-14 and Form MD-15).

Central Drugs Standard Control Organisation Guidelines & Compliance Standards

The Central Drugs Standard Control Organisation enforces strict regulatory measures for all foreign submissions. A foreign manufacturer cannot be located in India, so CDSCO rules require that there must be an IAA who will serve as the contact point in India for the purposes of medical device regulation, including:

• Submission of applications and other correspondence to the CDSCO;

• Technical support and assistance with product registration and licensing;

• Advice on compliance with the Medical Device Rules, 2017

• Reporting of adverse events when required by the CDSCO.

A CDSCO-compliant Indian entity acting as your CDSCO Agent must be your local partner. Therefore, without an IAA, a foreign manufacturer cannot follow the proper import procedure to bring its medical device into India. See also: challenges faced by overseas medical device manufacturers.

IAA vs import logistics (quick clarification)

• Indian Authorized Agent (IAA): IAA acts as a regulatory representative and guide who follows and understands CDSCO guidelines and guides in the process of licensing or entry to India

• Import Logistics: This is a part of the regulatory process where goods which need to be imported in India must have a clearance and certified as per norms of regulatory body but here they only hold license and give authorization to distributor for a for other processes.

Your IAA takes care of the regulatory side of obtaining the necessary medical device import license India. For related India import pathways, see CDSCO MD-26 / MD-27 medical device import in India and independent authorized representative & customs.

Key responsibilities of an IAA

A good IAA will typically:

• Prepare and manage CDSCO documents

• Help you with labeling compliance in India

• File Form MD-14 and assist you with issuance of Form MD-15 (Import License)

• Keep track of regulatory developments impacting your devices throughout the medical device approval process in India

• Coordinate with regulatory agencies for port/customs clearance purposes

• Supporting post market monitoring, complaints and adverse events reporting

For labeling rules, read: Medical device labeling requirements in India. For post market duties, see: Post market surveillance (PMS) services and PMS in India vs Europe & US FDA.

Who Can Act as an IAA vs Medical Device Manufacturing License India Holders

An Indian Authorized Agent (IAA) should be an entity legally registered in India and authorized to handle regulatory submissions. Unlike domestic entities seeking a Medical Device manufacturing license India requirement, foreign companies rely on an IAA for regulatory submissions. In practice, CDSCO usually requires the applicant to have sufficient knowledge of Indian regulations pertaining to medical devices, to submit the application to the Central Drugs Standard Control Organisation, and to provide the necessary documentation including adverse events and recalls, if applicable.

Obtaining a medical device import license India via CDSCO Process (MD-14 → MD-15)

Foreign manufacturers usually work through their IAA as follows:

1. Classification: CDSCO categorizes devices into risk classes A-D, and appropriate filing strategy is determined based on the device class. Guide: CDSCO medical device classification.

2. Submission: The IAA prepares the Form MD-14 application package which includes technical documentation (device master file, ISO 13485 documentation, risk analysis, etc.) depending on a device class and regulatory pathway. Related: Preparing a Device Master File (MDR 2017) · ISO 13485 quality management systems · CDSCO registration process & dossier guide.

3. CDSCO Review: CDSCO reviews the application and may issue queries. Once reviewed positively, an IAA receives Form MD-15 (import license) from CDSCO. Helpful: SUGAM query / rejection guidance.

4. Ongoing Compliance: IAA provides support throughout the device lifecycle to ensure regulatory compliance including post market surveillance and adverse event reporting if applicable.

Documents we commonly help assemble

Depending on the class of the device and requirements from CDSCO, such documents may include:

• Information about the device / product and technical file inputs

• ISO 13485 certificate

• Risk management files

• Labeling / IFU inputs adjusted to India requirements

• Power of attorney / authorization for the IAA

Other class specific forms and annexures required by the Central Drugs Standard Control Organisation: Plant Master File guide (MDR 2017) · Predicate table creation for CDSCO registration · Free Sale Certificate context. For companies transitioning between import channels and a medical device manufacturing license India route, document preparation varies.

Medical Device Approval Process in India: How Morulaa Acts as Your IAA

Many of the largest “top MD-15” Indian companies are Authorized Agents for their own MD-15 devices. Morulaa falls into the top 10 Indian companies in terms of unique MD-15 licenses (IAA). As an IAA, we represent more than 2,000 SKUs for foreign medical device manufacturers (as of 2026). In other words, we have extensive experience as a top tier CDSCO Agent at the manufacturer level, and we are ready to provide you with full fledged agent services. For example, your IAA can:

• Represent you in India as the Indian Authorized Agent (IAA)

• Provide guidance in classification and filing strategy

• Prepare documents for approval of MD-14 / MD-15 medical device import license India applications

• Respond to queries from CDSCO based on their extensive experience

• Align documentation for import and preparation of files for submission to CDSCO

• Support in post market surveillance and subsequent supervision

Learn more about Morulaa or explore the India regulations knowledge hub.

FAQ

Next step

India is a high growth market but CDSCO compliance is mandatory before you sell. Appoint an IAA that already operates at top tier MD-15 scale.