Test License for Medical Devices in India – Requirements, Process & Benefits

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The test license for medical devices in India is issued by the Central Drugs Standard Control Organization (CDSCO). This license guarantees that the medical device for clinical testing or investigations is exclusively made for this purpose. To get this license for medical devices testing, you should visit the official NSWS portal.

After filling out the Form MD-16, your application for the license will start being processed. You need to upload some required documents and pay a fee of US$ 100 per product. This article will help you understand the salient steps involved in getting a test license in India.


What Is a Medical Device Licence for Testing?

A medical device test license is a formal approval in the form of a document that approves a medical device to be appropriate for tests, evaluations, and clinical investigations. A test license for medical devices ensures that the importer or manufacturer meets the necessary quality standards for testing, examining, or conducting clinical studies/evaluations. A person who imports medical devices for testing in India needs to apply for this license. Local and foreign manufacturers of devices must file the test license application online.


Documents Required for Medical Device Test License Application

If you want your application for the test license to be accepted, furnish the following documents. Ensure that they are valid:

  1. A summary of your medical device which includes description, intended use, material of construction, design.
  2. Justify the required quantity of the device.
  3. The testing protocol or the clinical investigation strategy. The strategy or plan should be clinically approved.
  4. Quality management certificate, if any.
  5. Undertaking stating the use of the device for solely non-commercial goals.
  6. Undertaking from the testing lab, which verifies that it has the required facilities.


What Is the Medical Device Test License Application Fee?

The application fee for manufacturers is Rs. 500 for each medical device. The application fee for a test license for import is US$ 100 for every medical device.


Differences in the Test License Application Process for Local and Foreign Manufacturers

There are some significant differences in the process that local and foreign manufacturers should follow when submitting the medical device test license application. We have described the distinct needs in detail below.

Test Licence Application Needs for Local Manufacturers

Local manufacturers of medical devices for testing need to satisfy the following requirements to get the license:

  1. A valid National Single Window System (NSWS) account.
  2. A drafting application for the NSWS account.
  3. The documents you should upload must follow the Form MD 12 checklist.
  4. After submitting the application, you will receive approval in Form MD 13 by CDSCO.


Test Licence Application Needs for Foreign Manufacturers

Foreign manufacturers of medical devices for testing need to satisfy the following requirements to get the license:

  1. A valid National Single Window System (NSWS) account.
  2. A drafting application for the NSWS account.
  3. The documents you should upload must follow the Form MD 16 checklist. Visit NSWS Portal to get this checklist.
  4. After submitting the application, you will receive approval in the Form MD 17 by CDSCO.


Step-wise Process to Apply for the Test License for Medical Devices

Now that you know the major differences between the application needs for local and foreign manufacturers, let us explain the application process in detail.

  1. Navigate to the official web portal of National Single Window System (NSWS).
  2. Next, sign up on the NSWS portal. This is essential to register yourself.
  3. Fill out your personal and organizational details in the form that shows up. Read every detail carefully before progressing to the next one.
  4. Submit the needed documents as mentioned in the sections above. Ensure that you submit the documents according to the type of manufacturer you are.
  5. Your registered email address will get a verification link. Tap that link. Your account on the portal will get activated.
  6. Then you are able to apply for test license of medical devices after uploading the required documents.
  7. After submitting the complete application, it will go to the concerned official for review.
  8. If it is approved, you will get the approval in respective Forms.


Approval Process for the Application Received for Test License for Medical Devices

After you submit the application for obtaining a test license, it goes through many steps. Here’s what happens after you apply through the NSWS portal.

  1. Your application goes to the Nodal officer.
  2. The Nodal officer forwards it to the reviewing officer.
  3. After review application is forwarded to approving officer.
  4. Finally, you receive the approval of license.

Note that if between any of the steps above, there’s a deficiency of documents, a query will be generated.


Validity of the Medical Device Test License

Once approved, your medical device test license will be valid and usable for three years. It will be cancelled, if it does not meet the conditions of the license.


Reasons for Rejection/ Suspension/ Cancellation

In some cases, licensing authority may reject the test license application of medical devices due to the following reasons:

  1. You have not uploaded all the required documents after receiving repeated queries from the licensing authority.
  2. Issues related to the accuracy of the information in your documents.

According to the latest Medical Device Rules 2017 issued by the Ministry of Health and Family Welfare under the Government of India, the test licenses can be cancelled or suspended if they fail to match standards set by CDSCO.

Note that the Central Licensing Authority will give you the chance to submit the cause with evidence for your license to not get suspended or cancelled. Your evidence should be in written form.

What Testing Is Required for Medical Devices in India?

Different medical devices need different kinds of testing. Here are some of the major ways in which the devices are tested:

  1. Performance testing: This type of medical device testing ensures the reliability and effectiveness of the device. Through it, the device becomes ready to perform well in real-world scenarios.
  2. Safety testing: Safety testing is used to ensure that there are no potential threats or risks associated with the medical device. It takes into account considerations related to electrical, mechanical, thermal safety, and electromagnetic compatibility.
  3. Biocompatibility testing: This type of testing is crucial for products used on the human body, such as an implantable device. It checks the compatibility of the device with the blood and skin. This testing ensures that the device will not cause any unwanted reactions.

What Are the Benefits of a CDSCO Medical Device Test License?

A medical devices test license gives you many benefits. These include:

  1. The license makes the safety and performance of your devices to regulatory authorities evident. It is proof that your medical devices for clinical testing and investigations meet high and the latest standards of reliability.
  2. The license shows that you are capable of developing innovative devices that enhance the state of healthcare.
  3. You can enter the Indian market and be sure of the credibility of your device.
  4. Your reputation as an importer or manufacturer of high-quality and safe medical devices for testing undergoes a boost.
  5. The licence offers legal protection to you. It takes away the threat associated with regulatory penalties and sanctions.

How Can Dueran Consultant Help You?

The medical device test license in India is significant in ensuring and promoting patient health and healthcare in general. However, the process of acquiring it by manufacturers and importers in India is not easy. It involves a lot of planning and diligence. If you fail to comply with even a single rule, your license will be cancelled. But with the help of our experts at Dueran Consultant, you can navigate regulatory complexities seamlessly. We have long-standing experience as an end-to-end regulatory solutions provider in India. Our teams will give you all the information and take care of every single step involved in obtaining the license. With our aid, your license approval process will become effortless.

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