Indian Authorized Agent for Medical Devices
Regulatory Representation for Global Medical Device Manufacturers
Indian Authorized Agent for Medical Devices services are mandatory for foreign manufacturers entering the Indian market. Indian regulations require overseas manufacturers to appoint a locally established representative to manage regulatory submissions, authority communication, and ongoing compliance.
India represents one of the fastest-growing medical device markets globally. However, it also follows a highly regulated framework for medical devices. Therefore, foreign medical device manufacturers, global MedTech companies, and exporters must comply with Indian regulations before importing, marketing, or distributing medical devices in India.
Regacats Solutions provides medical device authorized agent service in India, supporting foreign manufacturers with regulatory representation, compliance coordination, and long-term market access in India.
What Is an Indian Authorized Agent (IAA) for Medical Devices?
A locally appointed Indian agent for medical devices by a foreign manufacturer to act as its official regulatory representative in India.
The Indian Authorized Agent:
Represents the foreign manufacturer before Indian regulatory authorities
Submits medical device registration and licensing applications
Coordinates responses to regulatory queries and inspections
Manages post-approval and post-market compliance obligations
As a result, the Indian Authorized Agent becomes the single point of regulatory accountability in India.
This service forms part of our broader Indian Authorized Agent services in India, supporting foreign manufacturers across regulated product categories.
Why Indian Authorized Agent (IAA) Services Are Mandatory for Medical Devices in India
India follows a local accountability regulatory framework for medical devices. Consequently, foreign manufacturers cannot directly interact with Indian regulators without appointing an Indian Agent.
Medical devices in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. CDSCO requires a locally accountable entity to ensure compliance, traceability, and enforcement.
Without an Indian Agent, foreign manufacturers may face:
Registration or license rejection
Import delays at Indian ports
Regulatory notices and penalties
Suspension or denial of market access
Who Requires an Indian Authorized Agent supporting medical device compliance?
IAA services apply to foreign manufacturers involved in:
Class A, B, C, and D medical devices
In vitro diagnostic (IVD) devices
Active and non-active medical devices
Software as a medical device, where applicable
Imported medical devices for the Indian market
Moreover, this requirement applies even when devices are already approved in other jurisdictions such as the US, EU, UK, South Korea, Australia or in other countries
Role of CDSCO in Import of Medical Device
CDSCO is the national authority responsible for regulating medical devices in India. It oversees:
Medical device registration and licensing
Import permissions and compliance
Quality system and documentation review
Regulatory inspections and enforcement
Foreign manufacturers must interact with CDSCO through an his Indian agent. Therefore, selecting an experienced regulatory representative directly affects approval timelines and compliance outcomes.
Key Responsibilities of appointed Indian Authorized Agent
An Indian Authorized Agent performs several critical regulatory functions for medical device import, including:
Acting as the official regulatory representative in India
Submitting medical device registration or license applications
Coordinating import-related regulatory requirements
Responding to CDSCO queries, notices, and inspections
Managing post-market surveillance and vigilance coordination
Supporting corrective and preventive actions
Because these responsibilities involve regulatory liability, foreign manufacturers must appoint an experienced and reliable Indian Authorized Agent.
How Regacats as Indian Agent Supports Global Medical Device Manufacturers
Regacats Solutions supports global medical device manufacturers and exporters across the complete regulatory lifecycle. From early market entry planning to post-approval compliance, we act as a long-term regulatory partner.
Our Indian Authorized Agent services support:
Regulatory feasibility and classification assessment
Market entry planning for India
Ongoing compliance and vigilance obligations
Risk mitigation for imported medical devices
As a result, global manufacturers can focus on commercial growth while maintaining regulatory compliance.
Our Indian Authorized Agent Services for Medical Device Compliance
Regacats Solutions provides end-to-end Indian regulatory representative for medical devices in India.
Regulatory Assessment & Device Classification
First, we assess device classification, intended use, risk category, and regulatory pathway under Indian regulations.
Appointment as Indian Authorized Agent
Next, we formally act as the Indian Authorized Agent, ensuring regulatory accountability within India.
Medical Device Registration & Licensing Support
Additionally, we manage registration and licensing submissions and coordinate with authorities throughout the review process.
Import Compliance & Authority Coordination
We also support import-related regulatory requirements and coordinate with port and customs authorities when required.
Post-Market Compliance & Vigilance Support
Finally, we assist with post-market surveillance, regulatory updates, and ongoing compliance obligations.
Consequently, foreign manufacturers benefit from predictable and structured compliance management.
Why Global Medical Device Manufacturers Choose Regacats Solutions
Global medical device manufacturers choose Regacats Solutions because we combine regulatory expertise with execution discipline.
8+ years of experience in Indian regulatory compliance
Strong expertise in medical device regulations
Proven support for global manufacturers and exporters
Transparent, compliance-first approach
PAN India presence with international client focus
Single point of accountability for Indian authorities
Therefore, our clients reduce regulatory risk while accelerating compliant market entry.
Importance of Choosing the right Authorized Agent for export of Medical Devices in India
An inexperienced Indian Authorized Agent can expose foreign manufacturers to compliance gaps, import delays, and enforcement action.
By contrast, Regacats Solutions ensures regulatory continuity, compliance integrity, and long-term market stability for global medical device manufacturers.
Our Structured Approach as authorized agent for medical device compliance in India
We follow a structured and transparent compliance approach:
Regulatory assessment and device classification
Formal appointment as Indian Authorized Agent
Submission of registrations and licenses
Continuous authority coordination
Post-market compliance and vigilance management
This structured approach ensures end-to-end regulatory coverage for medical device manufacturers.
Partner with Regacats Solutions as Your authorized regulatory representative for medical devices
Foreign medical device manufacturers and global MedTech companies should appoint an experienced Indian Authorized Agent early to avoid regulatory delays and compliance risks.
Regacats Solutions supports global medical device manufacturers as a trusted Indian Authorized Agent, enabling compliant, controlled, and successful market entry into India.
Frequently Asked Questions – Indian Authorized Agent for Medical Devices
Is an Indian Authorized Agent mandatory for imported medical devices?
Yes. Indian regulations require foreign medical device manufacturers to appoint a locally established Indian Authorized Agent.
Do global medical device manufacturers need an Indian Authorized Agent?
Yes. All foreign manufacturers exporting medical devices to India must appoint an Indian Authorized Agent.
Can one Indian Authorized Agent represent multiple medical devices?
Yes, provided regulatory scope and compliance requirements are met.
Can a foreign manufacturer change its Indian Authorized Agent?
Yes. Authorities permit changes, subject to prescribed procedures.
Does the Indian Authorized Agent carry regulatory responsibility?
Yes. The agent acts as the accountable representative before Indian authorities.
