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Licences & Registrations

CDSCO & Medical Devices

Importing or making medical devices, cosmetics or drugs? We guide you through CDSCO registration and licensing, from dossier to grant.

  • Medical-device import & manufacturing licences
  • Cosmetic import registration
  • Drug import / manufacturing support
  • Labelling, dossier & renewals

We prepare and coordinate; licences are granted by the CDSCO.

Get started — free consultation

Share your details and a specialist will call you back, usually within one business day.

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How it works

From first call to done

A clear, coordinated path — we handle the moving parts and keep you updated at every stage.

1

Free consultation

We classify your product and identify the right licence.

2

Dossier

We compile the technical dossier and documentation.

3

Authorised agent

We help set up the Indian authorised agent (for imports).

4

Application

We file on the CDSCO (SUGAM) portal.

5

Queries

We respond to deficiencies and queries.

6

Grant & renewals

You receive your licence; we manage renewals.

What you'll need

Documents you'll typically need

Have these ready and we'll take it from there. Everything is handled securely and used only for your work.

Company & product details
Device classification / composition
Manufacturing / quality certificates (ISO 13485, CE, etc.)
Free-sale certificate (for imports)
Labelling and pack inserts
Authorised-agent details
Why Fintex

Why businesses hand this to us

One accountable team

Books, registrations and your website handled under one roof — you brief one team, not five vendors.

Compliance-first, always

Correct filings and full documentation, on time. Everything is done by the book through proper channels.

A clear, guided process

You always know the current step and what comes next. We agree the scope together on a free consultation first.

We stay after setup

Renewals, returns and changes are handled long after the certificate or launch — we don't disappear.

Overview

Bring regulated health products to India, compliantly

Medical devices, cosmetics and drugs are tightly regulated by the CDSCO. The right licence depends on your product's risk class and whether you import or manufacture — and getting the dossier right is what determines your timeline.

Fintex Global classifies your product, builds the dossier, sets up the authorised agent where needed and manages the CDSCO process through to grant and renewal.

CDSCO & Medical Devices
Correct classification — the right licence for your device class.
Strong dossier — documentation prepared to reduce queries.
Import-ready — authorised-agent setup for overseas makers.
Lifecycle support — labelling, renewals and amendments handled.
FAQs

Questions, answered

How are medical devices classified?
By risk into classes A, B, C and D; the class drives the licence and process. We classify your device.
Do importers need an Indian agent?
Yes — imports generally require an authorised agent holding the licence; we help arrange this.
Are cosmetics covered?
Yes — imported cosmetics require CDSCO registration, which we handle.
What documents are critical?
Quality certificates (e.g. ISO 13485, CE), free-sale certificates and labelling; we guide the full list.
How long does it take?
It varies by product class and queries; we manage the dossier to keep it efficient.

Not sure where to start? Let's talk.

Book a free, no-obligation consultation. We'll understand what you need and map out the next steps — no pressure, no upfront commitment.

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