CDSCO Test License for Medical Device Performance Evaluation and Testing

In the medical sector, government mandates getting a device performance testing and evaluation. This testing is handled by getting a CDSCO test license. Whether a new thermometer is produced or designed by a team. Before selling to the market, it needs to prove, via official evaluation by authorities, that it can function properly, including reading temperature properly and giving accurate output.

This guide tells you what a CDSCO test license is, why you need one, and how to apply for it. 

What is a CDSCO Test License? Types

A CDSCO test license is a permission from the Central Drugs Standard Control Organisation (CDSCO), which is India’s national regulator for medicines and medical devices. It permits a company to make and then sell or even import a minimal number of medical devices specifically for testing, performance evaluation, clinical investigation, demonstration, or training.

You cannot get this license by purchasing it or paying someone. The only way to get it is to practise and prove your product’s ability to perform to set standards. 

There are two types of CDSCO Test Licenses:

Why Do You Need a Test License?

Under the Medical Devices Rules, 2017 (MDR-2017), almost every medical device in India is regulated, including early prototypes. Therefore, for most companies, test license is the first step toward full CDSCO registration for medical devices. The test results you collect are later used when you apply for a manufacturing license or even for a CDSCO import license via MD-15. 

Who Grants a CDSCO Test License and Who Can Apply?

The Central Licensing Authority under the Drugs Controller General of India (DCGI) grants the CDSCO test license. There are four risk classes, namely A, B, C, and D. For Classes A and B, state government authorities handle the regular manufacturing license testing and approval. 

You can also apply for this license if you are:

• Indian manufacturers and startups developing new devices

• Research and development organisations

• Importers bringing in samples from abroad 

• A CDSCO agent (an authorised Indian agent appointed by a foreign manufacturer)

Read More What is CDSCO Medical Device Import Certificate?

Applications of a CDSCO Test License: Where to Use

You can use the CDSCO test license to:

• Check performance, safety, and reliability at a CDSCO-registered testing lab

• Run clinical investigations to gather safety and effectiveness data

• Demonstrate the device to doctors, hospitals, or investors

• Train people on how to use or operate the device

Note: One test license by CDSCO can cover more than one testing site, as long as each site is listed with the quantity being tested there.

Documents Required to Get a CDSCO Test License

The exact list of documents is shown on the portal while applying.

Here’s the crux of the documents you should prepare for a CDSCO Test License:

• A covering letter

• Device details, including its intended use, materials, specifications, and design

• An undertaking that the devices are for testing only, not for sale

• A justification for the quantity you plan to make or import

• A test protocol or clinical investigation plan

• Lists of equipment and qualified staff

• Testing site details and an undertaking from the testing lab

• Quality certificates such as ISO 13485, if available

• Labels and Instructions for Use (IFU)

• A site plan of the premises (for manufacturing)

• An authorisation letter (for import applications)

• The fee payment receipt

Step-by-Step Application Process for a CDSCO Test License

The CDSCO online registration process is handled through the Medical Devices Online portal (cdscomdonline.gov.in) or the National Single Window System (also known as NSWS). Here are the steps to apply for it:

Step 1: The first step is identifying whether you need to get your medical device tested, evaluated, pass clinical testing, a demo, or training. 

Step 2: Then, create an account on the chosen portal and register your company.

Step 3: Fill out the forms as needed, such as MD-12 for manufacturing or MD-16 for import.

Step 4: Upload the needed documents as per the checklist shown on the portal from the list above and then pay the fees.

Step 5: After processing your application, CDSCO may ask for clarifications related to your devices’ performance. Answer them in simple and direct words.

Step 6: Once approved, the authority issues your CDSCO certificate in Form MD-13 or MD-17.

Read More What is CDSCO Registration?

Fees, Timeline, and Validity of a CDSCO Test License

The fees charged to apply for and get a CDSCO Test License are set in the Second Schedule of MDR-2017. There’s no fixed amount; however, the consultants usually quote around ₹500 per product for an MD-12 application. Ensure you check the current fees charged, as CDSCO does not issue refunds once the application is in process

The license is valid for three years from the date of issue. The approval for the license usually takes around 1.5 to 2 months max.

You can apply for this license on your own on the NSWS or the CDSCO portal; however, hiring a CDSCO consultant would simplify the process, save time, and reduce chances of rejections. These consultants also help with technicalities like testing formalities, document filing, test protocols, and more. Hire a CDSCO consultant and get your medical device legally approved now!

Frequently Asked Questions

1. Can I sell devices made under a test license?

No. Test licenses are strictly for testing, evaluation, clinical investigation, demonstration, or training.

2. What is the difference between MD-13 and MD-17?

The main difference between MD-13 and MD-17 is their usage. MD-13 lets you manufacture test devices in India. MD-17 lets you import them.

3. Is a test license the same as CDSCO registration?

No. The test license comes first. It helps you collect the data needed for full CDSCO registration and a permanent manufacturing or import license.