Medical Device Test License in India: MD-12 Application, MD-13 Licence, Fees and Process

What Is a Medical Device Test License?

A medical device test license is a licence from CDSCO that allows a company or institution to make or import small quantities of a medical device or IVD only for clinical investigation, testing, evaluation, examination, demonstration or training, and not for sale. To make devices, you apply on Form MD-12 and receive an MD 13 test license under Rule 31 of the Medical Devices Rules, 2017. To import them, you apply on Form MD-16 and receive an MD-17 licence under Rules 40 and 41.

The rules set clear numbers. CDSCO must decide within 30 days of the application. The licence is valid for three years from the date of issue. The fee is ₹500 for each distinct device to manufacture, and USD 100 for each distinct device to import. These numbers make a test license for medical devices India's quickest device approval, and the usual first step before a full manufacturing or import licence.

In India, test licence applications are filed on ONDLS or your state drug licensing portal and decided by the State Drug Licensing Authority. The state licensing authority grants manufacturing licences for Class A and B devices, but it does not grant test licences: every device test licence comes from CDSCO.

Who Needs a Test License for Medical Devices in India?

• Device start-ups building prototypes and pilot batches before their plant is licensed
• Existing manufacturers developing a new device that is not yet on their MD-5 or MD-9 licence
• IVD developers making kits for analytical and clinical performance evaluation
• Importers and foreign manufacturers bringing in samples for evaluation, testing or registration before the MD-15 import licence
• Hospitals, research institutes and sponsors running clinical investigations of new devices
• Distributors and companies that need demonstration or training units before commercial supply

If you will sell the devices, a test licence is not enough: you need a manufacturing licence (MD-5 or MD-9) or an import licence (MD-15). A test licence covers everything before that point.

Medical Device Test License Routes: Make, Import or Investigate

There are three related approvals, and choosing the right one first saves weeks:

Fees are from the CDSCO medical device fee list.

MD 13 test license for making devices

An MD 13 test license lets you manufacture a limited quantity of a device at the site named in the licence. It covers prototypes, pilot batches, verification and validation samples, biocompatibility and electrical safety test samples, stability samples and units for clinical investigation. The application is the MD 12 form medical device makers file with CDSCO, listing each device, its intended use, the quantity, the purpose and the site.

Manufacture medical device for performance evaluation

Many IVD and device developers need to manufacture medical device for performance evaluation: analytical studies of sensitivity, specificity and precision, or clinical performance studies on samples. These batches are made under an MD-13, and the results then support the Device Master File for the commercial licence. A new IVD that needs a clinical performance evaluation also needs CDSCO permission for that evaluation.

Medical device test licence for demonstration or training

A medical device test licence for demonstration or training covers units used to show a device to clinicians, regulators or buyers, or to train users, before commercial supply. The units cannot be sold, must stay at the places named in the licence, and must be accounted for at the end of use.

MD 16 MD 17 test license import and sample import of medical device for testing India

The MD 16 MD 17 test license import route covers samples brought from abroad for testing, evaluation, clinical investigation, demonstration or training. It is the legal route for sample import of medical device for testing India-wide, for example to test samples at an Indian laboratory before filing for an MD-15 import licence. CDSCO decides the quantity based on the purpose and the plan you submit, and the consignment must carry an invoice or statement showing the name and quantity of devices.

Test license for IVD kit

A test license for IVD kit development follows the same rules: MD-12 / MD-13 to make kits in India, MD-16 / MD-17 to import kits or reagents for evaluation. IVD applications should describe the analyte, specimen type, the studies planned and the number of tests needed, because the quantity is judged against that plan.

Medical device clinical investigation permission MD 22

A test licence lets you make or import the devices, but it is not permission to test them on people. A clinical investigation of an investigational device needs separate CDSCO permission: the medical device clinical investigation permission MD 22 application leads to permission on MD-23, with ethics committee approval and registration of the investigation. The fee is ₹1,00,000 for a pilot and ₹1,00,000 for a pivotal investigation. Many sponsors file the test licence and the investigation application together so devices are ready when permission arrives.

Test License for Class A and Class B Medical Devices

The question of a test license class A class B medical device makers ask most often is: does the state grant it? No. Although the State Licensing Authority grants manufacturing licences (MD-5 and MD-6) for Class A and B devices, the Medical Devices Rules give the test licence to the Central Licensing Authority for every class. So a Class B device maker in India gets its manufacturing licence from the state but its MD-13 test licence from CDSCO.

Test Licence vs Manufacturing Licence for Medical Devices

Eligibility for a Medical Device Test License

Anyone with a genuine need to make or import devices for the purposes in the rules can apply: manufacturers, start-ups, research institutions, hospitals, CROs, importers and Indian agents of foreign manufacturers. To be ready, you need:

1. A clear purpose: test, evaluation, clinical investigation, examination, demonstration or training
2. A defined device: description, intended use, risk class and, for IVDs, analyte and specimen type
3. A site: the place where devices will be made, tested or used, which is named on the licence
4. Equipment and people: for manufacture, the equipment and technical staff available to make the device
5. A quantity plan: how many units are needed for each test or study, with a reason
6. A record system: to track quantities made or imported, tested, stocked and disposed of

A full quality management system or ISO 13485 certificate is not a legal condition for a test licence, but evidence of design controls and a basic quality system strengthens the file.

Medical Device Test License Documents

The medical device test license documents depend on whether you make or import the devices.

For MD-12 (manufacture for test)

Rule 31(2) asks for:

• Description of the device, with its intended use, design, materials and specifications
• List of equipment and machinery available to make the device
• List of technical staff, with qualifications and experience
• Details of any existing manufacturing licence held by the applicant
• The purpose, quantity and site where the device will be used

In practice, CDSCO also expects:

• Covering letter and authorisation letter for the signatory
• Draft labels and instructions for use
• The test, evaluation or clinical investigation plan that justifies the quantity
• Proof of the site address and the applicant's constitution
• An undertaking that the devices will not be sold or supplied for any other purpose
• Fee payment receipt

For MD-16 (import for test)

• Covering letter and Form MD-16
• Device description, intended use and class
• Name and address of the overseas manufacturer
• Purpose, quantity and the place where the devices will be used or tested
• Test or investigation plan justifying the quantity
• Undertaking of non-commercial use
• Authorisation from the manufacturer, where the applicant is an Indian agent
• Fee payment receipt (USD 100 per distinct device)

For clinical investigation (MD-22)

The investigation plan, investigator's brochure, informed consent documents, ethics committee approval, investigator details, insurance and compensation arrangements, and evidence of safety from pre-clinical testing, as set out in the rules for clinical investigations.

Regovex prepares a consistent file in which the device description, quantity plan, labels and undertakings all match, which is what keeps a test licence inside the 30-day window.

Medical Device Test License Process

The medical device test license process is fully online and, with a complete file, short. In India, applications go to the State Drug Licensing Authority through ONDLS or your state drug licensing portal.

How to get test license for medical device

1. Confirm the route: MD-12 to make, MD-16 to import, plus MD-22 if you will run a clinical investigation.
2. Classify the device and confirm it is not a non-sterile, non-measuring Class A device outside Rule 31.
3. Write the plan: each test or study, the units needed and the site.
4. Prepare the documents listed above, with labels and an undertaking of non-commercial use.
5. Register on the portal as the applicant, or log in if already registered.
6. File the application and pay the fee: ₹500 per distinct device for MD-12, USD 100 per distinct device for MD-16.
7. Answer queries quickly and completely.
8. Receive the licence on MD-13 or MD-17, normally within 30 days of the application.

The MD 12 SUGAM application

The MD 12 SUGAM application is filed on CDSCO's online system for medical devices, which many applicants still call "MD SUGAM" because it grew out of CDSCO's SUGAM portal. The applicant registers once, with company details and a signatory, then files Form MD-12 for each set of devices, uploads documents and pays online. The same system is used for MD-16 import test licences and for the full manufacturing and import licences that follow.

Medical Device Test License Fees

The medical device test license fees are fixed in the Second Schedule of the Medical Devices Rules, 2017:

A "distinct device" is counted the way CDSCO counts devices in the application, so grouping models correctly keeps the fee down. Our professional fee is quoted in writing, with government fees shown separately.

Worked example

A start-up in India developing two Class B diagnostic devices needs pilot units of both for bench testing and usability studies. Its MD-12 fee is ₹500 × 2 = ₹1,000. If it also imports one comparator device for testing, the MD-16 fee is USD 100.

Medical Device Test License Validity

On medical device test license validity, the rules are clear: an MD-13 is valid for three years from the date of issue (Rule 31(5)), and an MD-17 is valid for three years from the date of issue (Rule 41(5)), unless suspended or cancelled earlier.

MD 13 licence validity and what happens after three years

The MD 13 licence validity of three years suits most development programmes. If you still need test devices after it ends, file a fresh MD-12 application with an updated plan before expiry, so testing is not interrupted. Better still, plan the move to a manufacturing licence before the test licence ends, because commercial supply can only begin under MD-5 or MD-9.

Cancellation and appeal

If the conditions are breached, CDSCO may cancel a test licence after a show-cause notice and a hearing. The licensee may appeal to the Central Government within 45 days of the order.

After the Test Licence: Conditions You Must Follow

A test licence is quick to get, but its conditions are strict. Under Rules 32 and 41:

• Use only for the stated purpose, at the place named in the licence: clinical investigation, test, evaluation, examination, demonstration or training
• No sale or supply to anyone outside that purpose
• Access for officers: any Medical Device Officer may enter the premises, with or without notice, to check that the devices are used as licensed
• Records: keep records of the quantity made or imported, tested, stocked and how each unit was used or disposed of; for imports, also the manufacturer's name, quantity and date of import
• Moving imported devices: notify CDSCO in writing before moving MD-17 devices to another place
• Unused imported devices: export them back or destroy them, with intimation to CDSCO

Labelling test and investigational devices

Rule 48 requires devices made or imported for test or clinical use to be labelled with the product name or code, batch or lot and serial numbers where applicable, the date of manufacture, the use-before date, storage conditions, the manufacturer's name and address, and the purpose for which the device is made. Clear labelling keeps test units separate from any commercial stock.

Records that make inspections easy

Keep a simple register for each licence with the device, batch or serial number, quantity, date, purpose, person responsible, test or study reference, and final disposition (consumed in testing, returned, exported or destroyed). Reconcile it every month. An inspector should be able to trace every unit from receipt or manufacture to its end.

Moving from test licence to commercial licence

When development or evaluation is complete, apply for the commercial licence: MD-5 or MD-6 from the state for Class A and B, MD-9 or MD-10 from CDSCO for Class C and D, or MD-15 for imports. Test data, verification and validation reports and clinical evidence generated under the test licence go into the Device Master File. See our medical device manufacturing license and medical device import license pages.

Common Mistakes in Medical Device Test Licence Applications

• Applying to the state for a Class A or B test licence. Every device test licence comes from CDSCO.
• No quantity justification. CDSCO sets the quantity against your plan; a bare number invites a query.
• Treating a test licence as permission to test on patients. A clinical investigation needs separate MD-22 / MD-23 permission and ethics approval.
• Using test units commercially, for example as free samples to hospitals, which breaches the licence.
• Moving imported test devices without telling CDSCO.
• Letting the three years run out while studies are still going on.
• Counting devices wrongly, which raises the fee or leaves models off the licence.

How to Write a Quantity Plan for a Device Test Licence

Under Rule 40(3), CDSCO decides the quantity for an import test licence by looking at the clinical investigation requirements and the plan you submit, and the same logic applies to MD-13. A plan that answers the reviewer's questions in advance usually goes through without a query:

Add a modest margin for repeats and failures, say so openly, and sign the plan. Regovex builds this plan with your engineers, because a plan the reviewer can follow is the single biggest factor in staying inside the 30-day window.

Test Licences for Different Device Teams

Device start-ups

A start-up's first approval is often an MD-13. It allows prototypes and pilot units to be made for verification, validation and early clinical evaluation, while the team prepares a quality system, a Device Master File and a site for the manufacturing licence. Planning both together shortens the path to market.

IVD developers

IVD developers usually need several test licence cycles: early kits for analytical studies, later kits from pilot lots for clinical performance evaluation, and imported reference kits for comparison. Each cycle should list the lots and the number of tests, so the quantity matches the study design.

Importers and foreign manufacturers

Before filing for an MD-15 import licence, many importers bring in samples on an MD-17 for testing at an Indian laboratory, for evaluation by hospitals, or for demonstration to buyers. The MD-17 holder must keep import records and either export or destroy unused units, with intimation to CDSCO.

Hospitals and clinical investigators

Hospitals running device studies need the devices to be made or imported under a test licence and the study itself to have CDSCO permission and ethics approval. Sponsors usually hold the test licence and supply the investigation sites listed on it.

Special Cases: Sterile Devices, Implants and Software

Sterile devices and implants

Sterile devices and implants need more test units than most products, because sterilisation validation, packaging integrity, shelf-life ageing and biocompatibility each consume samples. Plan these studies together and list them in one quantity plan, so a single MD-13 covers the whole validation programme rather than several small applications.

Software and connected devices

Software that meets the definition of a medical device, and connected devices with an app or cloud component, are classified by their intended use like any other device. Test units for usability, cybersecurity and clinical evaluation are made or imported under the same test licence routes. Describe the software version and intended use clearly in the application.

What a Medical Device Test Licence Does Not Cover

• Sale or free supply of the devices for routine use
• Use at places not named on the licence
• Clinical investigation on people without separate CDSCO permission and ethics approval
• Devices not listed on the licence, including new models or variants
• Commercial manufacture or import, which needs MD-5, MD-9 or MD-15

A Typical Medical Device Test Licence Timeline

Checklist Before You Apply

• Route decided: make (MD-12), import (MD-16), clinical investigation (MD-22)
• Device classified; not a non-sterile, non-measuring Class A device outside Rule 31
• Device description, intended use and draft labels ready
• Quantity plan written for each test or study, with a margin
• Site named and address proof available
• Equipment and technical staff lists ready (for manufacture)
• Overseas manufacturer details and authorisation ready (for import)
• Undertaking of non-commercial use signed
• Record register set up for receipt, use, stock and disposal
• Expiry date to be diarised the day the licence is issued

How to Choose an MD Test License Consultant

An MD test license consultant should get you to the next licence, not just this one. Ask:

1. Do you know that test licences come from CDSCO for every class? If not, keep looking.
2. Who writes the quantity plan and the device description?
3. Can you file MD-12, MD-16 and MD-22 together where a project needs all three?
4. Will you set up the records the rules require?
5. Can you take the device to MD-5, MD-9 or MD-15 when testing is done?

Why Device Teams in India Choose Regovex for Their Test Licence

• The right route first: MD-12, MD-16, MD-22 or a combination, decided before any document is drafted
• Correct classification and device grouping, so the fee and the device list are right
• Quantity plans that hold up, built from your test protocols and study designs
• Files that meet the 30-day window, with query replies within 24–48 hours
• Record and labelling templates that satisfy Rules 32, 41 and 48
• A path to commercial licensing: MD-5 / MD-6, MD-9 / MD-10 or MD-15, with the Device and Plant Master Files built from your test data
• Transparent pricing, with government and professional fees shown separately in writing
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback

As a CDSCO registration consultant and drug regulatory consultant in India, Regovex handles your test licence alongside every other device approval.

Medical Device Test License Services in India and Nearby Areas

Regovex helps device start-ups, IVD developers, manufacturers, importers, hospitals and research institutions in India. Applications are filed on ONDLS or your state drug licensing portal and decided by the State Drug Licensing Authority. Documents are collected digitally, so you do not need to visit any office.

We also serve businesses in .

Related services:

• Medical Device Manufacturing License in India
• Medical Device Import License (MD-15)
• CDSCO Registration in India
• MD-42 Registration in India
• Drug Test License (Form 29)

What Our Clients Say

"I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations." — Parichit Dhawan, Director, Feorah Wellness & Cosmetics

"I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval." — Bilal Ahmed Khan, Founder, Medwell Pharma

Medical device clients include Access 2 Healthcare and Project Life.