India · CDSCO
CDSCO India medical device registration
India now regulates every medical device under the Medical Devices Rules, 2017 — licensing closed on Class A and B in October 2022, and on Class C and D in October 2023. A foreign manufacturer cannot file alone: an Indian Authorized Agent applies in Form MD-14 for an MD-15 import licence. MD Regulatory gives you the documentation to prepare that submission correctly, the first time.
India kits
India documentation kits
Prepared against the Medical Devices Rules, 2017.
Start here
India CDSCO Gap Analysis
162-item scored workbook across 20 sheets, with a DO-NOT-FILE gate that flags killer items before CDSCO does.
€149View kit
India CDSCO Technical Dossier Kit
Fill-in Device Master File and Plant Master File templates on the Fourth Schedule structure, plus a master index.
€249View kit
Complete India bundle
Gap analysis + technical dossier kit
Everything to prepare a CDSCO import submission, at a saving.
€398
€349
Save €49How we help
A prepared submission, not a guess
Our kits are built from the Medical Devices Rules themselves — not summaries — and mirror the Device Master File and Plant Master File that a CDSCO import licence actually needs.
Straight from the regulations
Built on MDR 2017 and its Fourth Schedule, not third-party summaries.
Reuse your CE evidence
Essential principles under Rule 6, mapped to the matching EU MDR GSPR.
Know before you file
A scored gap analysis flags killer items before CDSCO does.
How registration works
Six steps from classification to import. The MD Regulatory kits carry steps 3 and 4.
01
Classify & group
Class A–D under the First Schedule of MDR 2017.
02
Appoint an Agent
An Indian Authorized Agent holding Form MD-42 or a licence.
03
Gap analysis
Score the file; close gaps before filing.
05
Apply in Form MD-14
Filed by the Agent on the CDSCO MD online portal.
06
MD-15 granted → import
The Central Licensing Authority grants the import licence.
04
Build DMF + PMF
Device and Plant Master Files on the Fourth Schedule.
Steps in magenta are where the MD Regulatory kits do the heavy lifting.
Two regulatory pathways
Registration
Class A non-sterile & non-measuring · lowest risk
Process
Exempt from the import licence. The device is registered on the CDSCO MD online portal and a registration number is issued.
Requirements
Device details on the MD online portal, conformity with the essential principles (Rule 6), and labelling that meets the Rules.
Timeline
Granted on self-declaration, without CDSCO technical review.
Renewal
No MD-15 to retain. Post-market and labelling duties still apply.
Import licence
Class A sterile or measuring, B, C & D
Process
The Authorized Agent applies in Form MD-14 to the Central Licensing Authority; the licence is granted in Form MD-15.
Requirements
Apostilled Power of Attorney, the Agent's MD-42 or licence, Free Sale Certificate, ISO 13485, Device Master File and Plant Master File.
Timeline
Several months. The Rules give the Central Licensing Authority nine months from application to decide or give reasons in writing.
Renewal
Valid in perpetuity, subject to a licence retention fee every five years.
What documentation is required
The file depends on whether the device is exempt or needs an MD-15 import licence.
For registration (Class A non-sterile & non-measuring)
Device and manufacturer details on the CDSCO MD online portal
Evidence of conformity with the essential principles (Rule 6)
Labelling that meets the Medical Devices Rules
ISO 13485 certificate of the manufacturer
For an MD-15 import licence
Form MD-14 application and fee challan
Power of Attorney and undertaking, apostilled (Fourth Schedule, Part I)
The Agent's Form MD-42, wholesale or manufacturing licence
Free Sale Certificate from the country of origin
Device Master File and Plant Master File (Fourth Schedule)
ISO 13485 certificate, CE certificate where applicable, labels and IFU
India
Prepared once, filed right
That is exactly the file the kits already carry — the MDR 2017 structure, the essential principles of Rule 6 and the Device and Plant Master File templates. So the file your Agent submits is the file CDSCO expects.
See the India kitsNeed a hand?
Not sure which kit — or want it done for you?
We can help you choose the right kit, review your completed file, or take on the full CDSCO submission as a consulting engagement.
Common questions
Yes. A foreign manufacturer cannot hold an import licence directly. You appoint an Indian Authorized Agent through an apostilled Power of Attorney; the Agent must hold a Form MD-42 registration certificate, a wholesale licence or a manufacturing licence, and files Form MD-14 on your behalf.
All of them, with one exception: Class A devices that are neither sterile nor measuring are exempt and only need to be registered on the CDSCO MD online portal. Licensing became mandatory for Class A and B in October 2022, and for Class C and D in October 2023.
They are the two technical documents the Fourth Schedule requires. The Device Master File covers the device itself — description, design, materials, testing, risk, labelling. The Plant Master File covers the manufacturing site: premises, equipment, personnel and quality system. Both are filed with Form MD-14.
It is valid in perpetuity unless suspended, cancelled or surrendered — but it is not maintenance-free. A licence retention fee falls due before the end of every five years from the date of issue. Miss it and a late fee of two per cent per month applies; after ninety days the licence is cancelled.
The Central Licensing Authority may inspect an overseas manufacturing site, itself or through a third party, and the applicant pays the cost of that visit. In practice overseas inspections have been rare, but the power exists and the fee is set in the Second Schedule.
A Free Sale Certificate or marketing authorisation from the regulator of the country of origin is part of the MD-14 file. For Class C and D devices with no approval from a reference market, CDSCO may require clinical investigation in India instead — which changes the project entirely, so establish this early.
The submission is made in English — India does not require a local-language dossier, which makes it lighter than markets such as Brazil. Devices must conform to the standards laid down by the Bureau of Indian Standards where these have been notified.
Ready to prepare your CDSCO file?
Start with the gap analysis, or take the complete India bundle.