CDSCO Medical Device Test License in India: Complete Guide on Form MD-12, MD-13, MD-16 & MD-17

• Apply for a Manufacturing Test License using Form MD-12 and receive approval via Form MD-13 under CDSCO regulations.
• Importers must use Form MD-16 to apply for an Import Test License, with the grant issued through Form MD-17.
• A CDSCO Test License is required to import or manufacture medical devices solely for the purpose of testing, evaluation, or clinical investigation in India.
• The complete application is submitted online through the SUGAM portal with mandatory documents and prescribed fees.

What Is a CDSCO Medical Device Test License?

If you are a medical device manufacturer or importer looking to bring a device into India purely for testing, clinical evaluation, or research purposes — before seeking full market authorization — you need a CDSCO Medical Device Test License. This is one of the most important yet frequently misunderstood regulatory steps in India's medical device registration process.

Under the Medical Devices Rules, 2017 (MDR 2017), the Central Drugs Standard Control Organization (CDSCO) regulates the import and manufacture of medical devices. A Test License is a specific, limited-purpose authorization that allows you to import or manufacture a medical device for the sole purpose of testing, evaluation, or clinical investigation — not for commercial sale.

Understanding the difference between a Test License and a full Import/Manufacturing License is critical. A test license does not permit you to sell or distribute the device commercially. It is purely a regulatory gateway for R&D, clinical studies, performance evaluation, and pre-market testing activities

.Key Insight: A CDSCO Test License is mandatory before conducting any clinical investigation of a new medical device in India. Skipping this step can lead to regulatory penalties and rejection of your marketing authorization application.

Types of CDSCO Medical Device Test Licenses

CDSCO issues two types of Test Licenses based on whether the activity involves manufacturing or importing:

Legal Framework and Regulatory Basis

The CDSCO Medical Device Test License is governed under the following legal provisions:

• Medical Devices Rules, 2017 (MDR 2017) — Notified under the Drugs and Cosmetics Act, 1940
• Rule 48 of MDR 2017 — Governs Import of Medical Devices for Test or Examination
• Rule 49 of MDR 2017 — Governs Manufacture of Medical Devices for Test, Examination or Analysis
• Schedule V of MDR 2017 — Prescribes the forms for test license applications (MD-12, MD-16)
• Schedule VI of MDR 2017 — Prescribes the forms for grant of test licenses (MD-13, MD-17)

As per these rules, any person who wishes to import or manufacture a medical device for the purposes of test, examination, or analysis — and not for sale — must obtain a valid test license from the Central Licensing Authority (CLA), which is the CDSCO.

Manufacturing Test License: Form MD-12 Application & Form MD-13 Grant

A Manufacturing Test License under Form MD-12 is required by any Indian-based manufacturer who wants to produce a medical device specifically for the purpose of internal testing, R&D evaluation, or submitting samples to regulatory bodies — without the intent of selling those devices commercially.

Who Needs a Manufacturing Test License (Form MD-12)?

• Indian medical device manufacturers conducting R&D on new device prototypes
• Companies manufacturing devices for submission to CDSCO or NABL-accredited labs for testing
• Organizations participating in clinical investigations requiring manufactured test samples
• Startups and research institutions developing new medical technologies for pre-market evaluation
• Manufacturers preparing for Class C or Class D device approvals who need validated performance data

What Is Form MD-12?

Form MD-12 is the official application form prescribed under Schedule V of the Medical Devices Rules, 2017 for obtaining a Manufacturing Test License. When you fill and submit Form MD-12 through the SUGAM portal, you are formally requesting CDSCO's permission to manufacture a specific medical device solely for testing purposes.

The form captures key information including the applicant's details, device description, intended testing purpose, manufacturing premises details, and the quantity of devices to be manufactured under the test license.

What Is Form MD-13?

Form MD-13 is the official Grant of Manufacturing Test License document prescribed under Schedule VI of MDR 2017. Once CDSCO reviews and approves your Form MD-12 application, they issue Form MD-13 as your license. This form specifies the conditions under which you may manufacture the device, the approved quantity, and the validity period.

Form MD-13 is your legal authorization. You must keep it available at your manufacturing premises at all times during the testing period.

Documents Required for Form MD-12 (Manufacturing Test License)

Manufacturing Test License Fee Structure

Note: Fees are subject to revision by CDSCO. Always check the latest Schedule VII of MDR 2017 or the SUGAM portal for current fee amounts.

Import Test License: Form MD-16 Application & Form MD-17 Grant

An Import Test License is required when a company or individual wants to bring a foreign-manufactured medical device into India for the purpose of testing, performance evaluation, clinical investigation, or sample examination — without commercially importing or selling the device.

This is a common requirement for multinational medical device companies conducting multi-country clinical trials, Indian distributors evaluating foreign products before commercial tie-ups, and research organizations importing reference standards or prototype devices.

Who Needs an Import Test License (Form MD-16)?

• Foreign medical device manufacturers seeking to conduct clinical trials in India
• Indian importers evaluating foreign medical devices for potential distribution partnerships
• Research hospitals and academic institutions importing devices for clinical investigation
• Contract research organizations (CROs) conducting multi-site clinical performance studies
• Quality testing laboratories importing devices for comparative testing or compliance verification

What Is Form MD-16?

Form MD-16 is the prescribed application form under Schedule V of MDR 2017 for obtaining an Import Test License. Submitting Form MD-16 via the SUGAM portal is how you formally apply to CDSCO for permission to import a specific medical device in limited quantities for testing purposes only.

The form requires details about the device, its foreign manufacturer, the testing purpose, the Indian applicant's regulatory status, and the quantity proposed for import.

What Is Form MD-17?

Form MD-17 is the Grant of Import Test License document issued under Schedule VI of MDR 2017. It is the official license that CDSCO grants once your Form MD-16 application is reviewed and approved. Form MD-17 permits you to import the specified device in the approved quantity for the stated testing purpose.

Importantly, Form MD-17 specifies the port of entry, the testing period, and the exact quantity permitted. Any import beyond these conditions is a regulatory violation.

Documents Required for Form MD-16 (Import Test License)

Import Test License Fee Structure

Eligibility Criteria for CDSCO Medical Device Test License

Not everyone can apply for a CDSCO Test License. Here is who is eligible:

Step-by-Step Process to Apply for CDSCO Medical Device Test License

Here is the complete application process for both manufacturing and import test licenses through the SUGAM portal in 2025–2026:

Step 1: Register on the SUGAM Portal

Visit sugam.cdsco.gov.in and create an account as an applicant (manufacturer or importer). Complete your company profile including CIN, PAN, and GST details. Existing CDSCO registrants can log in with their existing credentials.

Step 2: Select the Correct Application Module

On the SUGAM dashboard, navigate to the Medical Device section. For manufacturing test license, select Form MD-12. For import test license, select Form MD-16. Make sure you are selecting the test license module and not the regular import/manufacturing license module.

Step 3: Fill the Application Form

Complete all mandatory fields in the form. This includes device details (generic name, model number, classification, intended use), applicant information, premises details, testing purpose, proposed test quantity, and test site information. Double-check all entries before proceeding.

Step 4: Upload Supporting Documents

Upload all required documents as per the checklist provided in the previous sections. All documents must be in PDF format and should not exceed the size limits specified on the SUGAM portal. Ensure all certificates are valid and not expired at the time of submission.

Step 5: Pay the Application Fee

After completing the form and document uploads, you will be directed to the fee payment page. Pay the prescribed government fee online using net banking, NEFT, or the available payment gateway. Download the payment receipt (challan) for your records.

Step 6: Submit the Application

Review the entire application once more and submit it. You will receive an Application Reference Number (ARN). Note this number carefully — it is required for all future correspondence with CDSCO regarding your application.

Step 7: CDSCO Review and Query Resolution

CDSCO officials will review your application. If any information is missing or clarification is needed, they will raise a query (deficiency letter) on the SUGAM portal. Respond to all queries within the stipulated time to avoid application rejection. Timely response is critical.

Step 8: Issuance of Test License (Form MD-13 or Form MD-17)

Once CDSCO is satisfied with the application, they will issue Form MD-13 (Manufacturing Test License) or Form MD-17 (Import Test License). You will receive notification on the SUGAM portal and via registered email. Download and keep the license document safely.

Validity, Renewal, and Amendment of CDSCO Test License

How Long Is a CDSCO Test License Valid?

A CDSCO Medical Device Test License (both MD-13 and MD-17) is typically granted for a limited period tied to the specific testing activity for which it was applied. The validity period is determined by CDSCO at the time of granting the license based on the testing timeline proposed in your application.

• Standard validity: As approved by CDSCO — typically 1 to 3 years for clinical investigations
• For short-term testing/evaluation: May be granted for a period of 6 to 12 months
• The license is non-transferable and valid only for the device, quantity, and purpose specified

Can You Renew a CDSCO Test License?

Yes, test licenses can be renewed if the testing activity is still ongoing and has not been completed. You must apply for renewal before the expiry of the current license through the SUGAM portal. Late renewals attract additional fees. Always check current fee schedules on the portal.

What If the Testing Activity Is Complete?

Once the purpose for which the test license was granted is fulfilled — meaning the testing is complete — you must ensure that no quantity of the device manufactured or imported under the test license is diverted for commercial sale. Any unused devices must be accounted for and cannot be sold without obtaining the appropriate marketing authorization license.

Amendment of Test License

If there are changes to the device specifications, test protocol, testing site, or quantity, you need to apply for an amendment to the existing test license. Submit the amendment application through the SUGAM portal with supporting justification and revised documents. CDSCO will review and issue an amended license.

Medical Device Classification and Its Impact on Test License

India classifies medical devices into four risk-based classes under MDR 2017. The classification directly affects the complexity of your test license application, the fees payable, and the scrutiny level by CDSCO:

CDSCO Test License for Clinical Investigation of Medical Devices

If the purpose of your test license is to conduct a clinical investigation (clinical trial) of a medical device in India, additional regulatory requirements apply beyond the standard test license process:

• The clinical investigation must be conducted as per Schedule Y of the Drugs and Cosmetics Act (for devices used in clinical trials)
• An ethics committee (EC) approval from an CDSCO-recognized ethics committee is mandatory
• A Principal Investigator (PI) registered with CDSCO must be designated
• The clinical investigation plan (CIP) must comply with ISO 14155 — Clinical Investigation of Medical Devices for Human Subjects
• Informed consent forms (ICFs) must be approved by the ethics committee before recruiting participants
• SAE (Serious Adverse Event) reporting obligations apply throughout the clinical investigation

Failure to comply with clinical investigation requirements can result in CDSCO cancellation of the test license and regulatory action against the sponsor and investigators.

SUGAM Portal: How to Apply for CDSCO Medical Device Test License Online

The SUGAM portal is the official online regulatory submission platform of CDSCO. All medical device test license applications are processed exclusively through this portal. There is no offline or manual submission process currently active.

Key SUGAM Portal Features for Test License Applications

• Online form filling for MD-12 and MD-16 with field-level validation
• Document upload with supported format guidance (PDF, max size limits)
• Integrated fee payment gateway for government fees
• Real-time application status tracking with Application Reference Number (ARN)
• Query management — view and respond to CDSCO deficiency letters online
• License download (Form MD-13 / MD-17) directly from dashboard
• Email and SMS notifications at key application milestones

Tip: Create a dedicated SUGAM login for regulatory compliance tracking. Use the same account for all your CDSCO applications to maintain a consolidated history.

Benefits of Obtaining a CDSCO Medical Device Test License

Beyond regulatory compliance, here is why obtaining a proper CDSCO Test License is strategically beneficial:

Key Differences: Manufacturing Test License vs Import Test License

Conclusion: Getting Your CDSCO Medical Device Test License Right the First Time

Obtaining a CDSCO Medical Device Test License is not merely a bureaucratic formality — it is the legal foundation for all legitimate testing and clinical investigation activity involving medical devices in India. Whether you are a startup testing a breakthrough diagnostic device, a multinational conducting a multi-country clinical trial, or an Indian manufacturer validating a new product line, the test license under Form MD-12/MD-13 (manufacturing) or Form MD-16/MD-17 (import) is your starting point.

The process, when approached with complete documentation, the right device classification, and a clear test protocol, is straightforward. The most common reasons for delays are incomplete documentation, expired certificates, and inconsistent device descriptions across forms. Addressing these proactively will significantly reduce your application timelines.

Given the pace at which CDSCO is updating its digital processes through the SUGAM portal and aligning with international regulatory practices, staying current with MDR 2017 amendments and CDSCO guidance documents is essential. Always verify fee structures and document checklists directly on the SUGAM portal at the time of application, as these are updated periodically.

Frequently Asked Questions