Medical Device Licence & Import Registration
CDSCO licensing under the Medical Devices Rules, 2017
- 1ClassifyRisk class and authority identified.
- 2CompileTechnical files prepared.
- 3ApplyApplication, audit/testing and licence.
Share your details. We’ll reply on WhatsApp with the next steps and a checklist.
Pick a plan — the fee is adjusted if you hire us within 30 days.
About Medical Device Licence & Import Registration
A clear overview, in simple terms — what it is, why it matters, and how we handle it.
Medical devices in India are regulated under the Medical Devices Rules, 2017 and classified by risk into Class A (low) to Class D (high). Manufacturing licences for Class A and B devices are granted by the State Licensing Authority, and for Class C and D by CDSCO as the Central Licensing Authority. Importers of any class need an import licence from CDSCO. Applications are made on the SUGAM / online medical device portal with the device master file and plant master file.
Since the transition period ended in 2023, all classes of medical devices are under licensing, not just the earlier notified list. Getting the classification right is the first and most important step, because it decides the authority, documents, audits and timelines.
We prepare the device master file and plant master file, quality management system evidence (ISO 13485 is expected), labelling, and the application, and coordinate with your notified body or test labs where the class requires audit or testing.
| Law | Medical Devices Rules 2017 under the Drugs and Cosmetics Act |
|---|---|
| Classes | A (low) to D (high risk) |
| Class A/B manufacture | State Licensing Authority |
| Class C/D manufacture & all imports | CDSCO (Central Licensing Authority) |
| Key files | Device Master File, Plant Master File, ISO 13485 |
Who this is for
Common scenarios where this service is a good fit.
- Medical device manufacturers
- Importers and distributors of devices and diagnostics
- Foreign manufacturers appointing Indian agents
What you get
Clear deliverables so you know exactly what's included.
- Classification and regulatory pathway
- DMF and PMF preparation
- Application on the online portal
- Query response and audit support
Expert review before every submission — not just data entry.
Working notes and reconciliations you can rely on in future notices.
Resident Indians, NRIs, expats and cross-border businesses — all served.
Documents required
A practical checklist. We'll tell you if anything else is needed based on your case.
* This is a base checklist. After a quick pre-check, we may ask for additional items specific to your case.
Process
A simple, trackable workflow — designed to avoid back-and-forth.
Risk class and authority identified.
Technical files prepared.
Application, audit/testing and licence.
Get a quote
We share a clear quote on WhatsApp after a quick checklist pre-check.
- Fixed quote on WhatsApp after a short look at your facts and documents.
- Government fees, if any, are paid at actuals and shown separately.
| Factor | DIY | Indus Tax |
|---|---|---|
| Expert review | ❌ | ✅ |
| Notice risk reduction | ❌ | ✅ |
| Deduction optimisation | ❌ | ✅ |
| Audit-ready records | ❌ | ✅ |
| AIS/26AS reconciliation | ❌ | ✅ |
Share your facts and deadline. We'll reply with the right checklist and a clear quote.
Fee adjusted against our service fee if you go ahead within 30 days.
- Priority CA Call-backSkip the queue — a CA calls you within 30 minutes.₹255
- RecommendedCA Consultation (30 min)Talk one matter through properly with a CA.₹755
- In-depth CA Review (60 min)Documents reviewed before the call, written action plan after.₹1,155
Call-backs run Mon–Sat, 9 AM–6 PM IST. Booked outside these hours? We call you first thing the next working morning.
Compare the 3 plansFrequently asked questions
Answers to the most common questions we get.
Official sources
Indus Tax is a private professional services firm and is not affiliated with any government authority. Rules and fees change — we confirm current positions before filing.
