CDSCO Medical Device Test License 2026 Guide

Get complete assistance for CDSCO Test License approval in India for drugs and medical devices. From eligibility check to SUGAM portal submission and final approval, we ensure a smooth, compliant, and stress-free regulatory process under CDSCO guidelines for 2026.

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  • Guidance for Form 11, MD-12, MD-16, CT-16 & other approvals
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What Is a CDSCO Test License and Why Does It Matter?

Imagine you have developed a new medical device or drug and want to test it in India before selling it commercially. You cannot simply import or manufacture it without permission, even in small quantities. This is where the CDSCO Test License comes in. Issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, this license gives manufacturers and importers the legal right to produce or bring in small quantities of drugs or medical devices for testing, evaluation, demonstration, clinical investigation, or training purposes only and not for sale.

Without this license, your product is considered illegally imported or manufactured under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The CDSCO test license is your gateway to lawfully testing a product in India before you go through the longer, more expensive process of obtaining a full commercial license. Whether you are a pharma company testing a new molecule, a medical device startup evaluating a prototype, or a foreign company exploring the Indian market, this license is your first mandatory step. This guide breaks down everything you need to know, in plain, simple language.

 

What Is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, headquartered in New Delhi.

CDSCO is responsible for :

  • Approving new drugs and medical devices before they enter the Indian market
  • Issuing licenses for manufacturing, importing, and testing drugs and devices
  • Setting safety and quality standards
  • Regulating clinical trials in India
  • Overseeing the SUGAM portal : the official online platform for all CDSCO applications

Who Needs a CDSCO Test License?

A CDSCO Test License is required by anyone who wants to manufacture or import drugs or medical devices in India for testing purposes only, not for sale. The following groups of people and organizations need this license :

In the Pharmaceutical Sector :

  • Pharmaceutical companies importing drug samples for lab testing or bioequivalence (BE) studies
  • Contract Research Organizations (CROs) conducting clinical trials
  • R&D units approved by the Department of Scientific and Industrial Research (DSIR)
  • Academic or research institutions testing drug compounds
  • Companies testing active pharmaceutical ingredients (APIs)

In the Medical Device Sector :

  • Medical device manufacturers wanting to test Class A, B, C, or D devices
  • Foreign companies importing devices for evaluation before a commercial launch
  • Hospitals or labs receiving devices for clinical investigation or demonstration
  • Companies training their staff on device usage before market entry

In General :

  • Indian agents of foreign manufacturers
  • Companies with existing manufacturing licenses (Forms 25 or 28) who need test authorization for new products
  • Startups building new healthcare products for the Indian market

Which Products and Sectors Require It?

Drugs and Pharmaceuticals :

  • New chemical entities (NCEs)
  • API (Active Pharmaceutical Ingredients) for R&D
  • Drug formulations for bioequivalence studies
  • New drug formulations (extended release, modified release, etc.)
  • Drugs for clinical trials

Medical Devices :

  • Surgical instruments and implants
  • Diagnostic equipment
  • Orthopedic, cardiac, and neurological devices
  • In-vitro diagnostic (IVD) kits
  • Software as a Medical Device (SaMD)
  • Class A (lowest risk) to Class D (highest risk) devices

What Is NOT Covered :

  • Herbal, Ayurvedic, or agricultural products
  • Excipients (inactive ingredients)
  • Starting materials or raw ingredients
  • Banned drugs or prohibited substances
  • Veterinary drugs (separate licensing applies)
  • Diagnostic kits for veterinary use
 

Types of CDSCO Test Licenses

There are two main categories, one for drugs and one for medical devices : each with sub-types for manufacturing and importing.

For Drugs :

License TypeApplication FormLicense Issued InPurpose
Import of Drugs for TestingForm 12Form 11Import small quantities of drugs for examination, testing, or analysis
Import of Cosmetic/Phytopharmaceutical DrugsForm CT-16Form CT-17For cosmetic-related or phytopharmaceutical drug testing
Manufacture of Drugs for Testing:Form 29Manufacture drugs for test or analysis purposes
 

Eligibility Criteria

To apply for a CDSCO Test License, you must meet the following conditions :

Basic Eligibility :

  • Must be an Indian manufacturer or an authorized importer/agent registered in India
  • Must have a valid company registration and an active SUGAM portal account
  • Must clearly state the purpose : testing, evaluation, demonstration, or training only

For Drug Applicants :

  • Must hold a valid wholesale drug license (Form 20B/21B) or manufacturing license (Form 25/28), or a DSIR approval certificate
  • For new drugs, must provide a Form 29 license (manufacture for testing purposes)
  • For bioequivalence (BE) studies, must provide a BE NOC if the drug is a new drug
  • For extended/modified/controlled release formulations, these are treated as new drugs, so a BE NOC is needed

For Medical Device Applicants :

  • Must have a dedicated manufacturing facility or an approved testing laboratory
  • Must provide a signed undertaking that the devices will be used only for testing, not for commercial sale
  • Must justify the quantity of devices required for testing
  • Must show proof of required infrastructure and qualified personnel

Documents Required

For Drug Test License (Form 12 / Form 11) :

  • Covering letter includes firm name, address, purpose, and list of documents
  • Form 12, signed and countersigned by the head of institution or authorized company director
  • TR-6 Challan bank receipt as proof of fee payment
  • Form 29 : license to manufacture for testing (required for new drug APIs)
  • Form 25 or Form 28 of existing manufacturing license with product permission (for old drugs)
  • Utilization/Justification, detailed breakdown of quantities for each test parameter, batch sizes, number of batches
  • Notarized Undertaking/Affidavit, especially when large quantities are requested, explaining need with test parameters
  • BE NOC, required when importing drugs for bioequivalence studies on new drugs
  • Notarized Agreement, if the testing facility belongs to a different company
  • DSIR Approval Certificate is mandatory for R&D units
  • Authority Letter is needed when collecting approval/query letters in person

For Medical Device Test License (MD-12 / MD-16) :

  • Application Form MD-12 (for manufacturing) or MD-16 (for importing)
  • Device description, intended use, design, materials used, technical specifications
  • Device Master File, detailed technical documentation
  • Quality Management System (QMS) certificate, ISO 13485 or equivalent
  • Test protocol or clinical investigation plan : specific tests, number of patients, study duration, test site details
  • Justification of quantity, why you need the specific amount for testing
  • Undertaking from testing lab, confirming the availability of required facilities and that devices are not for sale
  • Labeling and Instructions for Use (IFU), including warnings and precautions
  • Free Sale Certificate (FSC), from the country of origin (for imports)
  • Ethics Committee Approval, if conducting clinical investigations on human subjects
  • Authorization letter, for importers or Indian agents acting on behalf of foreign manufacturers

Step-by-Step Process to Apply For Drug Test License :

Step 1 : Prepare Your Documents

Gather all required documents as listed above. Make sure the Form 12 is signed and stamped by the authorized signatory of your company.

Step 2 : Register or Log In to the SUGAM Portal

Visit the official CDSCO SUGAM portal. Create a new account if you do not already have one. Complete your manufacturer or importer profile.

Step 3 : Pay the Fees

Pay the required government fees via TR-6 challan at the Bank of Baroda, KG Marg, New Delhi, or any notified branch. Attach the signed and bank-stamped challan to your application.

Step 4 : Submit the Application Online

Fill out the application in Form 12 or Form CT-16 on the SUGAM portal. Upload all supporting documents.

Step 5 : Application Review by CDSCO

CDSCO will review your application. If there are any missing documents or technical questions, a query letter will be issued. You must respond to all queries within the stipulated timeline.

Step 6 : Receive the Test License

Once CDSCO is satisfied with your application and documents, Form 11 or CT-17 will be issued electronically via the SUGAM portal.

Step-by-Step Process For Medical Device Test License :

Step 1 : Register on the SUGAM Portal

Create and verify your account on the CDSCO SUGAM portal and complete your company profile.

Step 2 : Classify Your Device

Identify the correct risk class of your medical device : Class A (lowest risk), B, C, or D (highest risk) : under the Medical Devices Rules, 2017.

Step 3 : Prepare Technical Documentation

Prepare all required documents including device description, test protocol, QMS certificate, IFU, and quantity justification.

Step 4 : Submit Application

File the online application in Form MD-12 (for manufacturing) or Form MD-16 (for importing) through the SUGAM portal. Upload all documents and pay the applicable government fees.

Step 5 : CDSCO Scrutiny

CDSCO will review the application. Technical or regulatory queries may be raised. You must respond accurately and on time.

Step 6 : License Granted

Upon satisfactory review, CDSCO will issue the test license : Form MD-13 (for manufacturing) or Form MD-17 (for importing) : electronically through the SUGAM portal.

 

Benefits of Obtaining a CDSCO Test License

Legal Authorization to Test

Without this license, even importing one unit of a medical device or drug sample for testing is illegal. The test license gives you full legal protection.

Safety and Efficacy Validation

You get a structured, legal framework to test whether your product is safe, effective, and performs as intended : before investing in full commercial manufacturing.

Supports Research and Development

R&D teams and Contract Research Organizations (CROs) can conduct clinical trials, bioequivalence studies, and performance evaluations legally under this license.

Smooth Customs Clearance

Medical devices and drug samples imported under a valid CDSCO test license will not face customs issues or seizures at Indian ports.

Regulatory Compliance

Having this license shows that your company follows Indian regulatory laws. This builds trust with CDSCO, hospitals, testing labs, and future business partners.

Pathway to Full Commercial License

After successful testing and evaluation, you can use the data gathered under the test license to apply for a full manufacturing or import license from CDSCO.

Enables Market Readiness

Before a commercial launch, you can demonstrate your product to distributors, hospitals, and healthcare professionals : legally and compliantly.

Reduces Risk of Product Failure Post-Launch

Since the product has been thoroughly tested before market entry, the risk of safety issues or regulatory action after the commercial launch is significantly reduced.

Fee Structure and Timeline for CDSCO Test License

Fee Structure for Drug Test License :

  • Form 12: INR 5,000 for the first drug + INR 2,000 for each additional drug
  • Form CT-16: INR 5,000 per drug
  • Under the old TR-6 challan system: INR 100 for the first drug + INR 50 for each additional drug (for older applications)

Maximum Drugs Allowed :

  • Up to 10 different drugs under a single Form 11 license

Timeline :

  • Form 11 : 7 working days
  • CT-17 : 45 working days

For Medical Devices :

Test License to Manufacture :

Manufacture small quantities of medical devices for testing, evaluation, demonstration, or training

Test License to Import :

Import small quantities of medical devices for testing, clinical investigation, or training

Timeline :

  • Typically 4 to 8 weeks depending on documentation and CDSCO queries

Validity of CDSCO Test License

License Validity Table :

License TypeValidity Period
Form 11 (Drug Import)Typically 1 year (no renewal : fresh application required)
Form CT-173 years from date of issue
Form MD-13 (Device Manufacturing)3 years from date of issue
Form MD-17 (Device Import)3 years from date of issue
Form 29 (Drug Manufacturing for Testing)1 year (renewable annually)

Important Note on Renewal :

  • Form 11 (drug test license) cannot be renewed. Once it expires, you must file a completely fresh application with all documents and a new TR-6 challan.
  • Medical device test licenses (MD-13 and MD-17) may be extended by applying before the expiry date.

What Are You Allowed and NOT Allowed to Do?

You ARE allowed to :

  • Manufacture or import the specific quantity of drugs/devices stated in the license
  • Conduct testing, analysis, evaluation, clinical investigation, demonstration, or training
  • Use the product at the location specified in your license
  • Use drugs imported under Form 11 for animal studies : but only with IAEC approval or CPCSEA permission

You are NOT allowed to :

  • Sell or commercially distribute the drugs or devices
  • Use the product at any location other than the one specified in the license
  • Import more than 10 different drugs under a single Form 11 license
  • Use the license for banned, prohibited, herbal, Ayurvedic, or agricultural substances
  • Import excipients or starting materials under this license
 

Post-Approval Requirements

Record Keeping :

  • Maintain a detailed record of all drugs or devices manufactured or imported under the license
  • Record the quantity imported or manufactured, the date, and the name of the manufacturer or supplier

Reporting :

  • Report details of imported substances to the licensing authority, including quantities, importation dates, and manufacturer names

Restricted Use :

  • Use the licensed products only at the location specified in the license
  • Any change of testing location must be pre-approved by CDSCO

Inspection Readiness :

  • Allow CDSCO-authorized inspectors to enter your premises : with or without prior notice : to inspect how the products are being stored and used

Storage Compliance :

  • Store all drugs and devices under proper storage conditions as per the product requirements

No Commercial Activity :

  • Do not sell, advertise, or distribute any product licensed under the test license in any commercial manner

Respond to Queries Promptly :

  • If CDSCO issues a query or deficiency letter at any point, respond promptly with complete, accurate information

License Validity Tracking :

  • Monitor your license expiry date
  • For Form 11, start fresh application preparations well in advance
  • For medical device test licenses, apply for extension before expiry

Penalties for Non-Compliance

Manufacturing or Importing Without a License :

  • This is a cognizable offence under the Drugs and Cosmetics Act
  • Can result in imprisonment of up to 3 years, a fine, or both

Selling Products Licensed for Testing :

  • Selling a drug or device under a test license is a violation of the Act
  • Can lead to cancellation of the test license and further legal action

Misuse of License :

  • If a licensee violates any of the conditions of the test license, CDSCO can cancel the license
  • The licensee can appeal to the Central Government within 3 months of the cancellation order

False or Misleading Documentation :

  • Submitting forged undertakings or falsified test protocols can attract criminal charges under Indian law

Non-Compliance During Inspection :

  • Refusing entry to a CDSCO inspector or failing to maintain proper records can lead to show-cause notices, suspension, or cancellation of the license.
 

How to Use the SUGAM Portal for CDSCO Test License

Step 1 : Visit the Portal

Go to the CDSCO SUGAM portal (https://cdscomdonline.gov.in), the official website for medical device and drug regulatory submissions in India.

Step 2 : Create Your Account

Click on "New Registration" and fill in your company details, type (manufacturer or importer), and contact information.

Step 3 : Complete Your Profile

Fill in your company's manufacturing or import profile, GST details, and authorized signatory information.

Step 4 : Select the Right Application Form

  • For drug import testing: Form 12
  • For drug cosmetic/phytopharmaceutical testing: Form CT-16
  • For medical device manufacturing testing: Form MD-12
  • For medical device import testing: Form MD-16

Step 5 : Upload Documents

Upload all required documents in the prescribed format. Make sure file sizes and formats comply with the portal's requirements.

Step 6 : Pay Fees

Pay the applicable government fees online through the portal.

Step 7 : Track Your Application

Log in regularly to check your application status. Respond to any queries raised by CDSCO through the portal itself.

Step 8 : Download Your License

Once approved, your test license will be issued electronically and can be downloaded from the portal.

How CDSCO Compares to FDA Regulations 

FeatureCDSCO (India)FDA (USA)
Governing LawDrugs and Cosmetics Act, 1940 / Medical Devices Rules, 2017Federal Food, Drug, and Cosmetic Act
Test License ConceptForm 11 (drugs), MD-13/MD-17 (devices)Investigational Device Exemption (IDE) / IND for drugs
Online PortalSUGAM PortalFDA eSubmitter / CDER Direct
Device ClassificationClass A, B, C, DClass I, II, III
Clinical Investigation ApprovalEthics Committee + CDSCO approvalIRB + FDA approval
Test License Validity1–3 yearsVaries by application type
Selling Under Test LicenseNot permittedNot permitted

Key Takeaways

  • A CDSCO Test License is mandatory before you manufacture or import any drug or medical device for testing in India : even a single unit.
  • There are different forms for drugs (Form 11, Form 29, CT-17) and medical devices (MD-13, MD-17).
  • You can apply through the SUGAM portal online for most applications.
  • The license is for testing only, no commercial selling is allowed under it.
  • Form 11 for drugs cannot be renewed, a fresh application is always required.
  • Medical device test licenses are valid for 3 years and can be extended.
  • Penalties for misuse or non-compliance can include imprisonment, fines, and license cancellation.
  • Proper documentation, especially the quantity justification and test protocol is the most important factor in getting your license approved quickly.
 

Need Help with CDSCO Test License?

Get expert assistance with CDSCO Test License registration for drugs and medical devices in India. Our compliance specialists handle the entire process—from documentation preparation to SUGAM portal submission and approval tracking—so your business stays fully compliant with CDSCO requirements under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.

📞 Call: 8796104190
📧 Email: support@psrcompliance.com

Written by

Raju Karn

Raju Karn

SEO Team Lead · PSR Compliance

5+ Years Experience

Raju Karn has 5+ years of experience writing compliance content covering CPCB, CDSCO, BIS, EPR, FSSAI, WPS, PESO and various small and large business registrations, licenses and certifications across India.

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Frequently Asked Questions

No. Drugs imported under Form 11 are exclusively for examination, testing, and analysis. Commercial sale is strictly prohibited.

Yes, but only with IAEC (Institutional Animal Ethics Committee) approval or CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) permission. A copy of the subject drug must also be provided.

No. Form 11 cannot be renewed. You must apply fresh with a new TR-6 challan and all required documents.

A maximum of 10 different drugs can be imported under a single Form 11 license.

Yes. Form MD-13 allows Indian manufacturers to produce small quantities of Class A, B, C, or D medical devices for testing and evaluation purposes only.

You must respond to the query letter with a point-by-point reply, attaching the original query letter, your application reference, and a covering letter with the file number.

Not directly. A foreign company must appoint an Indian Authorized Agent who can apply on its behalf.

The rule permits "small quantities." If you are importing a larger quantity, you must provide detailed justification through a notarized undertaking with specific test parameters, batch sizes, and number of batches.

You must submit a notarized agreement between your company and the testing facility.

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