Medical Device Test Licence in India: Requirements, Application Process and Compliance Guide

Understanding the medical device test license in India is essential for manufacturers, importers, innovators and research organisations planning to manufacture or import medical devices for non-commercial purposes.

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Devices Rules, 2017. These rules establish specific requirements for manufacturing and importing medical devices for clinical investigations, testing, evaluation, examination, demonstration or training.

The CDSCO test license for medical devices is different from a commercial manufacturing or import licence. It permits specified activities under defined conditions and does not automatically authorise commercial sale or distribution.

This guide explains when do you need a medical device test license, the applicable forms, documentation, fees, application procedure and regulatory considerations.

What Is a CDSCO Test License for Medical Devices?

A CDSCO test licence is a regulatory authorisation for manufacturing or importing small quantities of medical devices for specified non-commercial purposes.

Under the Medical Devices Rules, 2017, the manufacturing and import pathways are governed by separate provisions.

• Rule 31: Manufacturing medical devices for testing and related purposes.
• Rule 38: Importing medical devices for testing and related purposes.

The relevant application and licence forms are:

These forms are used for the purposes specified in the rules, including clinical investigations, testing, evaluation, examination, demonstration and training.

A test licence should not be confused with a commercial manufacturing or import licence. Devices covered by a test licence must be used only for the authorised purpose and in accordance with the licence conditions.

When Do You Need a Medical Device Test License?

Understanding when do you need a medical device test license requires an assessment of the proposed activity, device classification and applicable regulatory provisions.

A test licence may be required when an organisation plans to manufacture or import small quantities of medical devices for activities such as:

1. Clinical investigations

Manufacturers and innovators may need devices for clinical investigations to collect information about their safety and performance.

However, a test licence does not automatically authorise a clinical investigation. Separate regulatory permissions and ethics committee approvals may be required, depending on the nature of the investigation and the applicable provisions.

2. Laboratory testing and evaluation

Medical devices may require testing to assess their performance, functionality, safety or compliance with relevant technical specifications.

Where the proposed activity involves manufacturing or importing devices specifically for testing, the applicable test-licence requirements should be assessed.

3. Demonstration and training

Devices may be manufactured or imported for authorised demonstrations or training activities involving healthcare professionals, researchers or other relevant stakeholders.

The devices must remain within the scope of the approved purpose and licence conditions.

4. Design verification and validation

Innovators and manufacturers may need prototype or test-batch devices to evaluate design performance and generate technical data.

The appropriate regulatory pathway depends on whether the activity involves manufacturing, import, testing of existing devices or another regulated activity.

Important: Not every testing or research activity automatically requires an MD-13 or MD-17 licence. The applicable provisions and exemptions must be reviewed before starting the activity.

Medical Device Testing License Requirements India

The medical device testing license requirements India depend on the type of application and the proposed activity.

For a manufacturing test licence, the application is submitted in Form MD-12. For an import test licence, the application is submitted in Form MD-16.

The application should include the information and supporting documents prescribed by the applicable rules and the current CDSCO checklist.

Key application information

Applicants should prepare the following information, as applicable:

• Description of the medical device, including its intended use and relevant technical characteristics.
• Device classification and proposed quantity.
• Details of the applicant and the proposed manufacturing or testing location.
• Details of the facilities, equipment and qualified personnel available for the proposed activity.
• Relevant technical documents and supporting information.
• Existing manufacturing licence details, where applicable.
• Foreign manufacturer authorisation and import-related technical documents, where applicable.

The exact documentation should be confirmed against the current CDSCO checklist for the relevant form.

Applicants should not assume that the same document list applies to both manufacturing and import applications.

CDSCO Test License Validity

Under Rule 31, a manufacturing licence granted in Form MD-13 remains valid for three years from the date of issue unless it is cancelled earlier.

The validity of the import test licence should be assessed separately under the applicable import provisions.

Applicants should also review any licence-specific conditions and applicable amendments before relying on a particular validity period.

How to Get Medical Device Test License in India

The how to get medical device test license process involves selecting the correct regulatory pathway, preparing the application and submitting the required information to CDSCO.

Step 1: Identify the applicable regulatory pathway

Determine whether the proposed activity involves manufacturing or importing medical devices.

For manufacturing, review Rule 31 and Form MD-12.

For import, review Rule 38 and Form MD-16.

Step 2: Confirm device classification

Identify the applicable medical device classification and assess whether any exemption applies.

This is particularly important for non-sterile and non-measuring Class A medical devices, which are exempt from the licensing regime under the relevant amendment.

Step 3: Prepare the application dossier

Compile the required application information, technical documents and supporting records.

Use the latest official CDSCO checklist for the applicable form rather than relying solely on a general document list.

Step 4: Submit the application online

CDSCO identifies the SUGAM portal as the online application pathway for manufacturing and import test licences.

Applicants should verify the current portal instructions and applicable submission requirements before filing.

Step 5: Pay the prescribed fee

Pay the applicable fee in accordance with the Second Schedule and the current portal instructions.

Step 6: Respond to regulatory queries

CDSCO may review the application and seek additional information or clarification.

Applicants should respond with accurate, complete and relevant documentation. Processing time may vary depending on the application and any queries raised.

Step 7: Comply with licence conditions

After the licence is granted, ensure that the devices are used only for the approved purpose and location.

Maintain the records required by the applicable provisions and comply with the conditions specified in the licence.

Import Test Licence for Medical Devices in India

A medical device import license India application for testing and related purposes follows a separate regulatory pathway from manufacturing.

Form MD-16 is the application form, while Form MD-17 is the corresponding import test licence.

The application should include the information required under the applicable provisions, including relevant foreign manufacturer authorisation and technical documentation.

The imported devices must be used only for the purposes authorised under the licence. The import test licence should not be treated as permission for unrestricted commercial import or sale.

Clinical Investigation Requirements: An Important Distinction

A medical device clinical investigation license India requirement should be assessed separately from the test-licence requirement.

The Medical Devices Rules, 2017 contain provisions governing clinical investigations and other activities involving investigational medical devices.

A test licence may be relevant when devices need to be manufactured or imported for a clinical investigation. However, the test licence itself does not replace any separate permission required to conduct the investigation.

Before initiating a study, applicants should assess the applicable requirements for regulatory approval, ethics committee review, informed consent and other relevant obligations.

Why Partner with MDR CONSULTANTS for Medical Device Regulatory Support in India?

Navigating medical device regulations requires careful review of the applicable rules, forms, documentation and regulatory pathway.

An experienced medical device regulatory consultant in India can assist manufacturers, importers and innovators in understanding their obligations and preparing applications.

MDR Consultants can support organisations with:

• Regulatory pathway assessment and device classification.
• Preparation of documentation for Form MD-12 and Form MD-16.
• Application submission and regulatory query responses.
• Guidance on test-licence conditions and documentation.
• Assessment of clinical investigation requirements.
• Support with regulatory planning for subsequent commercial licensing.

The scope of professional support should be agreed according to the applicant's device, proposed activity and applicable regulatory requirements.

Conclusion

The medical device test license in India provides a regulatory pathway for manufacturing or importing small quantities of medical devices for specified non-commercial purposes.

The Medical Devices Rules, 2017 establish separate manufacturing and import procedures through Forms MD-12/MD-13 and MD-16/MD-17.

Understanding when do you need a medical device test license, confirming the applicable classification and exemptions, preparing the correct documentation and complying with licence conditions can help organisations avoid unnecessary regulatory delays.

Applicants should also distinguish a test licence from any separate approval required for a clinical investigation.

For accurate regulatory planning, always refer to the latest official CDSCO notifications, application checklists and the complete text of the Medical Devices Rules, 2017 before submitting an application.

Last Updated : 16 Sep 2026