Medical Device Test License (Form MD-12/13)

A Medical Device Test License is the first step when you’re trying to test or clinically investigate a new or imported medical device in India. Before launching any device into the market, it’s important to make sure that it’s safe, reliable, and performs as expected. But to conduct such a test legally, you are required to legally get this license. Even if you’re a manufacturer, importer, or research organization, you should obtain a test license in the form MD 12 or MD 13 based on your requirements. In this blog, you will get to know all the details related to the medical device test license, its procedure, validity, timeline, and many more. 

What Is a Medical Device Test License (Form MD-12/13)?

A medical device test license (Form MD-12/13) is an official permission issued by the Central Drugs Standard Control Organization in India. The permit allows manufacturers, importers, or research organizations to legally manufacture or import medical devices only for testing, evaluation, clinical investigation, or demonstration purposes, and not for commercial sale.

Basically, there are two types of test licenses based on the source of the device:

From MD 12 – Issued for importing medical devices for test or evaluation.

Form MD 13 – Issued for manufacturing medical devices in India for test, clinical trials, or demonstration.

Why Is A Medical Device Test License Required For Testing or Clinical Investigation?

A medical device test license (Form-12/13) is needed because it ensures that any testing, clinical investigation, or research on a medical device is done legally, ethically, and safely under government supervision.

• To Ensure Safety and Quality – Prior to new or imported medical devices on humans or animals for testing. It should be checked to make sure it’s not harmful. The license ensures that proper testing methods are used to protect the safety of patients and testers.
• To Follow Government Rules – As per the Medical Device Rule 2017, you can’t test or clinically investigate a device without official permission from the CDSCO. The Test license makes the process legal and traceable.
• To Avoid Misuse or Illegal Sale – This license confirms that the device is being used only for non-commercial purposes, such as testing or evaluation, not for selling in the market.
• For Scientific Validation – Clinical investigation or performance testing helps collect data to prove that the device works as intended. The license is required so that these tests are conducted properly with official records.
• To Gain Approval For Future Sale – If a company wants to eventually sell a new medical device in India, the data from tests and investigations becomes necessary for getting final approval from the  CDSCO.

Who Needs to Apply For A Medical Device Test License In India?

In India, anyone who wants to test, evaluate, or conduct clinical investigations on a medical device without selling it should apply for a medical device test license form (MD-12/13).

• Manufacturer
• Importers
• Research Organizations/Clinical Trial Institutions
• Hospitals or Labs Partnering in Investigations

What is the Difference Between Form MD 12 and Form MD 13?

Forms MD-12 and MD-13 are both types of medical device test licenses issued by the CDSCO in India. Although they serve a similar purpose to allow testing, clinical investigation, or demonstration. They are used in different situations based on how the medical device is sourced.

When Should You Apply For A Medical Device Test License (Form MD-12/13)?

You should apply for a medical device test license (Form-12 or MD-13) before starting any testing, evaluation, clinical investigation, or demonstration of a medical device in India, and definitely before importing or manufacturing the device for such purposes.

• Before Importing a Device for Testing
• Before Manufacturing a Device for Non-Commercial Use
• Before Starting Clinical Investigation or Performance Evaluation
• Before Demonstrating the Device to Authorities or Clients

Which Types of Medical Devices Require A Test License Before Clinical Trials or Evaluation?

A medical device test license (Form MD-12 or MD-13) is required for any medical device that needs to undergo clinical investigation, performance evaluation, or demonstration before it can be sold in India. 

• New or Innovative Medical Devices
• High Risk (Class C and Class D) Devices
• Imported Devices Awaiting Indian Approval
• Modified Versions of Approved Devices
• Devices for Demonstration Purposes
• In Vitro Diagnostics (IVD) Devices Under Evaluation

Procedure To Apply for A Medical Device Test License In India?

If you want to apply for a Medical Device Test License (Form MD-12 or MD-13) in India, the applicant should follow a step-by-step process given by the CDSCO under the MDR, 2017. 

Check the Correct Form 

• Form MD-12 – If you’re importing a medical device for testing or clinical investigation
• Form MD-13 – If you are manufacturing a medical device in India for the same purpose.

Register on the CDSCO SUGAM Portal 

• First visit to the CDSCO official portal
• Create an account as a manufacturer or importer
• Get approval from the licensing authority

Prepare the Required Documents

• The full document list is mentioned in the next answer

Submit the Online Application

• Fill out Form MD-12 or MD-13 on the porta;
• Upload all the documents
• Pay the government fees online
• Submit  

Application Review By CDSCO

• CDSCO will review your application and may raise queries or ask for clarification
• Respond to queries (if any) promptly through the portal

Issuance of Test License 

• The test license (Form MD-12 or MD-13) will be issued in digital format and made available for download on your SUGAM portal dashboard.

Documents Required For Obtaining a Medical Device Test License?

To apply for a Medical Device Test License in India, whether for import (Form-12) or manufacture (Form MD-13), you have to submit the following documents:

• Cover Letter
• Device Details
• Test Purpose Declaration
• Undertaking by the Applicants
• Protocols for Testing/Clinical Investigation
• Details of Testing.Clinical Sites
• Undertaking for Proper Disposal
• Details of Principal Investigator
• Authority Letter/Power of Attorney
• Government Fee Payment Receipt
• Free Sale Certificate
• CE Certificate
• Label of the Imported Device
• Importer’s IEC Certificate
• Manufacturing Site Details
• ISO 13485
• Manufacturing License
• Process Flow Chart

What is The Validity Period Of A Medical Device Test License?

Basically, a Medical Device Test License (Form MD-12 or MD-13) is valid for 3 years from the date of issuance. 

How Long Does It Take To Get A Medical Device Test License Approved?

The approval time for the Medical Device Test License (Form MD-12 or MD-13) normally takes around 2 to 4 weeks from the date of application, if all the documents are correct and complete. 

• Completeness of the application
• Type and class of medical device (Class C & D may take longer)
• Whether CDSCO raises any queries or needs clarification
• Speed of responses to queries on the SUGAM Portal

Why Choose ELT Corporate for Medical Device Test License Consultation?

ELT Corporate is one of the best regulatory consultancy firms specializing in CDSCO medical device licensing and compliance support. Here we help in simplifying the process of obtaining a medical device test license by offering complete guidance, documentation support, and follow-up by ensuring a smooth and hassle-free approval expertise from start to finish. 

• Expertise in CDSCO Compliance
• End-to-End Licensing Support
• Fast and Error-Free Application
• Support for Both Importers & Manufacturers
• Transparent Process & Timely Update
• Trusted by Startups and Global Brands

Get in touch to secure a medical device test license application. You can reach us at info@medicaldeviceregistration.com or call us directly at 9899997002.