Authorized Representation

Authorized License Holding, Hassle-Free

CDSCO-recognized representation for foreign manufacturers. We hold your import license, manage vigilance, and handle every regulatory touchpoint while you focus on the device.

Why teams choose us

CDSCO-recognized AIAFast query responseLifecycle managementLong-term partnerships
CDSCO AIAVigilanceRenewalsMDRVariations
What's included

Everything your license needs, handled

A single retainer covers license-holding, vigilance, renewals, and regulatory correspondence.

Authorized Indian Agent (AIA)

CDSCO-recognized representation under our local registration.

Import license holding (MD-15)

Filed and held under our entity; commercial control stays with you.

Vigilance & adverse-event reporting

MDR submissions, field-safety notices, and ongoing surveillance.

Renewals & variations

License renewals tracked proactively, variations filed on time.

Regulatory correspondence

CDSCO queries and inspections handled promptly.

Transfer support

Clean license transfer to your own Indian entity when you set one up.

Our process

A predictable AIA engagement

Six clear steps from onboarding to ongoing operations.

  1. 01

    AIA agreement

    Scope of representation, response SLAs, fee structure agreed in writing.

  2. 02

    License application

    MD-14 filed under our entity with your technical file.

  3. 03

    License issuance (MD-15)

    License held by us; you appear as foreign manufacturer of record.

  4. 04

    Vigilance setup

    PMS plan, MDR reporting workflow, and contact tree established.

  5. 05

    Annual maintenance

    PSUR / PER updates, renewal tracking, regulatory monitoring.

  6. 06

    Optional transfer

    License transfer to your Indian subsidiary when you incorporate one.

Why us

Why Bio-State for license holding

#1

CDSCO-recognized track record

A clean license-holding history across many foreign manufacturers.

Having a dependable Authorized Indian Agent meant our regulatory obligations in India were handled without us having to worry about them.
Founder, foreign medical device manufacturer
#2

Conflict-free representation

We don't distribute or sell devices — pure regulatory representation.

#3

Fast query turnaround

CDSCO queries answered promptly, often within the same day.

#4

Transparent fee structure

Annual retainer covers everything — no surprise charges for routine work.

Case study

A real engagement, real outcomes

License Holder · AIA

Foreign manufacturer — Authorized Indian Representative

Seamless regulatory representation in India

A foreign manufacturer without an Indian legal entity needed an Authorized Indian Representative. We provided License Holder/Authorized Agent services, managed regulatory correspondence, coordinated import license activities, and supported post-market surveillance obligations.

Authorized

Indian representative

Managed

Regulatory correspondence

Coordinated

Import licensing

Ongoing

Compliance support

FAQ

Common questions

Quick answers about scope, timelines, and how this engagement runs.

Ask us directly

Any foreign manufacturer applying for import licenses without an Indian subsidiary. CDSCO requires every import license application to be filed by an Indian entity.

No. The AIA holds the license on your behalf. All device design, brand, and commercial rights remain entirely yours.

Yes — we support license transfer when you set up an Indian subsidiary. We have a documented transfer process that takes 8–12 weeks.

It depends on portfolio size and complexity. We share a transparent fixed-fee quote upfront before you commit.

Yes. We don't distribute, sell, or market devices commercially. Pure regulatory representation only — no commercial conflicts.

Hold your India license without the headache

Tell us your portfolio and target markets. We'll send a transparent AIA fee proposal within 48 hours.