CDSCO Test Licence for Medical Devices and Drugs
A CDSCO test licence lets you make or import small quantities of a medical device or drug for testing, evaluation, demonstration or training, without a full commercial licence. For devices it is Form MD-13 (manufacture) or Form MD-17 (import), decided within 30 days and valid for three years. We file the application and help you keep the records an inspector will ask for.
What it is
A test licence is a limited permission from the Central Drugs Standard Control Organisation (CDSCO). It allows a small quantity of a product to be made or imported only for non-commercial purposes: testing, evaluation, examination, demonstration, training or clinical investigation. Nothing made or imported under it can be sold.
For medical devices, including in vitro diagnostics, the Medical Devices Rules, 2017 provide two routes. Rule 31 covers manufacture, with an application in Form MD-12 and a licence in Form MD-13. Rules 40 and 41 cover import, with an application in Form MD-16 and a licence in Form MD-17. For drugs, Rule 33 of the Drugs Rules, 1945 allows import for examination, test or analysis under a licence in Form 11, applied for in Form 12. New drugs have their own forms under the New Drugs and Clinical Trials Rules, 2019. All of these are filed online with CDSCO.
Who it applies to
Device makers building prototypes
A start-up or MSME designing a new device needs a few units for bench testing or performance evaluation before it applies for a manufacturing licence. Founders often pair this with Startup India recognition.
Importers evaluating a product
A distributor that wants to try a foreign device or diagnostic kit, or demonstrate it to hospitals, before committing to a full import licence. Picture a Faridabad supplier who wants five analysers for demos at NCR hospitals before signing a distribution deal.
Pharma units testing a drug
A manufacturer or lab that needs samples of a drug for examination, test or analysis, for example to develop a formulation. The commercial side later needs a State drug licence.
Why it matters
It is the legal way to get samples
Regulated devices and drugs cannot be made or imported without a licence, even a handful. The test licence is the route the rules provide for small quantities.
It feeds the main application
Test and evaluation data from these units often support the later manufacturing or import licence application.
It is decided fast
For devices, the Central Licensing Authority must decide within 30 days. A full import licence can take up to nine months.
Documents required
For manufacture (MD-12)
- Description of the device: design, materials, intended use
- List of equipment and qualified technical staff
- Any existing manufacturing licence or research approval
- Premises details
For import (MD-16)
- Device details and the purpose of import
- Quantity required and the sites where it will be used
- Manufacturer details and product information
For drugs (Form 12)
- Names and quantities of the drugs
- Purpose: examination, test or analysis
- Place where the testing will be done
- Applicable fee paid online
How it works
Match your product to the right form
Making or importing? Device, drug or new drug? Each answer leads to a different form, and filing the wrong one costs weeks. We settle this first.
Size the quantity to your test plan
CDSCO grants test licences for small quantities linked to a stated purpose. Here is the catch: a number that looks commercial invites queries. In practice, we tie each unit to a test, a demo or a training session in your plan.
File online and pay the fee
We register you on the CDSCO portal, upload the documents and pay the fee set by the rules.
Answer queries and get the licence
For devices, the authority grants or rejects within 30 days. We answer queries the same week they arrive.
Keep a register from day one
Licensees must record quantities made or imported and how they were used. We set up a simple register you can show to an inspecting officer.
Test licence routes at a glance
| Product | Application | Licence | Rule |
|---|---|---|---|
| Medical device / IVD, manufacture | Form MD-12 | Form MD-13 | Rule 31, Medical Devices Rules, 2017 |
| Medical device / IVD, import | Form MD-16 | Form MD-17 | Rules 40–41, Medical Devices Rules, 2017 |
| Drug, import for examination, test or analysis | Form 12 | Form 11 | Rules 33–34, Drugs Rules, 1945 |
| New drug, import for clinical trial, BA/BE study or test | Form CT-16 | Form CT-17 | New Drugs and Clinical Trials Rules, 2019 |
| New drug, manufacture for clinical trial, BA/BE study or test | Form CT-10 | Form CT-11 | New Drugs and Clinical Trials Rules, 2019 |
Timelines
Decision in 30 days
Rules 31(3) and 41(1) of the Medical Devices Rules, 2017 require a decision on MD-13 and MD-17 applications within 30 days.
Valid for three years
Device test licences are valid for three years from issue under Rule 41(5). CDSCO’s FAQs give the same three-year validity for Form CT-17.
Plan the next step early
Use the three years well. A Gurugram device start-up that finishes bench testing in year one can file its manufacturing licence while the test licence still runs, instead of waiting until it lapses.
What happens if test stock is misused
Sale is not allowed
Selling units made or imported under a test licence breaks the licence condition that they are used only for the stated purpose.
Licence can be cancelled
CDSCO can suspend or cancel the licence. That history then sits on your file when you apply for the full licence.
Gaps in your records
Without a register of quantities and use, you cannot show an inspecting officer where the units went.
Frequently asked questions
What is a CDSCO test licence used for?
A test licence lets you make or import a small quantity of a regulated product for non-commercial use only. Under the Medical Devices Rules, 2017 the permitted purposes are clinical investigation, test, evaluation, examination, demonstration and training. For drugs, Rule 33 of the Drugs Rules, 1945 allows import for examination, test or analysis. Nothing covered by a test licence can be sold.
Which form do I use for a medical device test licence?
It depends on whether you are making or importing the device. To manufacture, you apply in Form MD-12 and receive Form MD-13 under Rule 31. To import, you apply in Form MD-16 and receive Form MD-17 under Rules 40 and 41. Both routes also cover in vitro diagnostic devices, and both are filed online with CDSCO.
How long does CDSCO take to issue a device test licence?
The Central Licensing Authority must grant or reject the application within 30 days under Rules 31(3) and 41(1) of the Medical Devices Rules, 2017. That is far shorter than the nine months allowed for a full import licence. A clear statement of purpose and quantity keeps queries to a minimum, which helps the file move inside that window.
How long is a test licence valid?
A medical device test licence in Form MD-13 or MD-17 is valid for three years from the date of issue under the Medical Devices Rules, 2017. CDSCO’s FAQs on the New Drugs and Clinical Trials Rules, 2019 give the same three-year validity for a Form CT-17 licence. We note the expiry date for you and remind you well before it.
What is the fee for an import test licence for IVDs?
CDSCO’s IVD FAQ states a fee of USD 100 for an import test licence in Form MD-17, the same for Class A, B, C and D devices. It is paid online in the rupee equivalent when the MD-16 application is filed. Fees for other test licences are set in the respective schedules, and we confirm the exact figure before filing.
Can one test licence cover more than one site?
Yes, for in vitro diagnostic devices CDSCO’s FAQ confirms that several sites can be listed in a single test licence application. This helps when evaluation runs at more than one lab or hospital. List every site at the start, because each one must be named in the application to be covered by the licence.
Does a test licence allow me to run a clinical trial?
No, the test licence only covers making or importing the product. Running a clinical investigation of a device or a clinical trial of a new drug needs its own permission from CDSCO under the relevant rules, along with ethics committee approval. We can file the test licence so the product is ready when the trial permission comes through.
What records must a test licence holder keep?
You must keep a record of the quantity made or imported and how it was used, and make it available to inspecting officers. For devices, Medical Device Officers can verify these records. For drugs under Rule 33, the record covers the names, quantities, dates and manufacturers. We set up a simple register at the start so this stays easy.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fee example: USD 100 for an IVD import test licence in Form MD-17, as stated in CDSCO’s IVD FAQ. Other test licence fees follow the Second Schedule of the Medical Devices Rules, 2017, the Drugs Rules, 1945 or the Sixth Schedule of the NDCT Rules, 2019.
Our role
We handle the application and documents, file on the portal, deal with CDSCO queries and set up your records. The testing, evaluation and clinical work itself is done by your own technical team, accredited laboratories or investigators. We do not run a lab or certify results.
Ready to begin?
Tell us the product, the quantity and why you need it, and we will tell you the right test licence form and file it.