Companies planning to test the quality and safety of medical devices before full-fledged sale need to obtain a test license. A CDSCO test license will enable manufacturers/importers to manufacture or import small quantities of medical devices for evaluation purpose. Medical devices are a vital component of the healthcare system. They are used to diagnose, monitor, and treat patients. Thus, ensuring quality, efficacy, and safety are pivotal for these healthcare essentials. CDSCO strictly regulates medical devices marketed in India to protect the public health. Medical device companies need to abide by the CDSCO regulatory requirements to sell their products in India. CDSCO medical device test license will enable manufacturers/importers to evaluate their products before launching them in the Indian market. In this blog, we will highlight the importance of and how to obtain a medical device test license in India.

What is a CDSCO medical device test license?

As per Indian regulations, even small quantities of medical devices cannot be manufactured/imported for testing purpose without a proper license. Manufacturers/importers planning to evaluate the medical device’s safety for patient use need to secure a CDSCO medical device test license. With this license, only small quantities of medical devices can be manufactured or imported. The license permits production for testing purpose only and not for sale. The test license for medical devices will allow the entity to perform clinical investigations, evaluation, testing, demonstrations, and training. The CDSCO test license allows manufacturers/importers to collect data on device safety and efficacy without having full manufacturing/import licenses.

Types of CDSCO medical device test license:

• Test license to manufacture medical devices: Form MD-13 is the CDSCO test license required for manufacturing medical devices for testing purposes. The license will permit manufacturing small quantiles of medical devices for clinical research, evaluation, demonstration, and training. The manufacturer needs to apply for the license using the Form MD-12. The applicant needs to pay the fees and upload the necessary supporting documents. CDSCO will grant the test license for manufacturing medical devices via Form MD-13. This test license for medical devices will allow manufacturing all classes of medical devices in small quantities.
• Test license to import medical devices: Form MD-17 is the CDSCO test license required for importing medical devices for testing purposes. The license will permit import of small quantiles of medical devices for clinical research, evaluation, demonstration, and training. The manufacturer needs to apply for the license using the Form MD-16. The applicant needs to pay the fees and upload the necessary supporting documents. CDSCO will grant the test license for importing medical devices via Form MD-17. This test license for medical devices will allow import of all classes of medical devices in small quantities.

The need for medical device test license in India

Medical devices have a significant impact on patient safety and outcome. They form the backbone of the healthcare industry, as they are used to diagnose, monitor, and treat patients. In India, the demand for medical devices is high. Thus, medical device companies are aiming to enter the Indian medical market. Hence, there is a need for stringent guidelines to regulate the quality of medical devices entering the Indian market. The regulatory guidelines ensure the medical devices meet certain quality, efficacy, and safety benchmarks before they are marketed. The Indian regulatory guidelines require the medical devices entering the Indian market be tested for quality, safety, and efficacy. Otherwise, companies may market substandard unsafe medical devices, which can be detrimental for the patient’s health.

Furthermore, Indian regulatory guidelines control the medical device testing process in India. Indian medical device regulations do not permit the manufacture/import of medical devices even for testing purposes without proper licenses. A CDSCO medical device test license is required. The CDSCO test license ensures the medical devices is imported or manufactured solely for testing and not for commercial purpose. By issuing this license, CDSCO ensures the devices are properly tested and assessed before they are marketed in India. The license is a vital component of Indian medical device regulatory framework. After proper clinical evaluation and testing, the medical device company may apply for permanent CDSCO manufacturing or import license.

Necessary documents and requirements for CDSCO medical device test license

For obtaining a test license for medical devices, certain criteria have to be fulfilled. Various supporting documents will be required while applying for a medical device test license in India. The following is an overview of the necessary documents:

• Description of the device: A description of the device detailing its intended use, design, material used for construction, and specifications.
• Quality certificate
• Undertaking stating the medical device will be used for testing and not for commercial purposes.
• Justification of the required quantity: A statement justifying the proposed quantity of medical devices for testing purposes.
• A detailed testing plan: For medical devices produced for clinical investigation, a detailed testing plan is required. The plan should present the specific tests, number of patients involved, and study duration, etc.
• The place where the demonstration, evaluation, testing, clinical trials, and training will be performed should be specified.
• An undertaking from the laboratory where the tests will be performed stating the availability of the required facilities.
• Medical device labelling and Instructions for Use (IFU): Proper medical device labelling and IFU, including any warnings or precautions, should be clearly provided.

Validity of the medical device test license in India

The CDSCO test license for medical devices is usually valid for 3 years subject to compliance with the applicable rules. However, the validity period may vary depending on the device type, testing plan, and other parameters. After the validity expires and the medical device is successfully assessed, the company may apply for a permanent manufacturing/import license. However, if further tests need to be carried out post the validity period of the license, the medical device company needs to apply for an extension. The extension should be applied for prior to the expiry of the license. The medical device test license extension application will be reviewed by CDSCO prior to approval.

How to apply for CDSCO medical device test license in India?

1. Create an account in the online portal and register your company
2. Apply for CDSCO test license using the applicable form (Form MD-12 for manufacture and Form MD-16 for import)
3. Upload all the necessary documents
4. Pay the applicable fees
5. CDSCO will review the application and verify the documents. Then, the regulatory body will issue a test license via Form MD-17 for import or Form MD-13 for manufacture, if the necessary criteria are satisfied.

Benefits of the CDSCO medical device test license

• Ensures all medical devices entering the Indian market have been assessed for their safety and quality.
• Companies can perform clinical evaluation and test the product prior to marketing it.                                                                                
• Internal trainings and demonstrations can be performed prior to launching the product in the market.
• Medical devices imported for testing purpose under CDSCO test license will not face customs issues.
• The test license helps ensure regulatory compliance.

Test license for medical devices: A vital component of medical device regulation

Given the vital role medical devices play, it is crucial to ensure they are effective and safe for patient use. To safeguard public health, CDSCO issues medical device test licenses to help companies test their products prior to launching them. Medical device companies can assess their products and perform clinical evaluations before marketing them. The license should be used to solely perform clinical investigations, tests, training, and demonstrations and not sell the product in the market. With the various documents needed and regulatory requirements, obtaining CDSCO medical device test license can be an arduous procedure. However, the Pharmadocx Consultants team will ensure you obtain your test license for medical devices without major hiccups. Our expertise in document preparation, license application, and regulatory guidelines will make the process seamless. Drop your requirements at [email protected] or call/Whatsapp on 9996859227 and we will get back to you.