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In India, if you want to make or bring in small amounts of medical devices for certain purposes, you need to follow specific rules outlined in Chapters IV and V of the Medical Device Rules (MDR) 2017. These rules allow companies to do important things like clinical testing, evaluations, or training without needing full manufacturing or import licenses. Let’s take a closer look at what’s involved in getting a test license for medical devices, who’s eligible, and why it’s important.
Who Can Get a Test License?
If you’re a company planning to import or make small quantities of medical devices for testing, evaluation, demonstration, or training, you’ll need a test license approved by the Central Drugs Standard Control Organization (CDSCO). But remember, if you want to do these things for commercial reasons, you’ll need a different kind of license i.e. manufacturing license or import license.
How to Apply for a Test License:
Create an Account: First, you’ll need to make an account on the NSWS portal and register.
Fill Out the Forms: Then, fill out the right form — MD-16 for import or MD-12 for manufacturing — and submit it.
Upload Documents: You’ll have to upload various documents that CDSCO requires.
Pay the Fee: There’s a fee you have to pay along with your application.
Wait for Approval: CDSCO will review your application and, if everything looks good, they’ll issue your test license.
What Documents Do You Need?
You’ll need to provide a brief description of your medical device, explain why you need to make or bring in a certain amount, show that you have quality certifications, and more. It’s essential to have all the necessary paperwork in order.
How Much Does It Cost?
The fee depends on whether you’re making or importing the device. For manufacturing, it’s INR 500 per device, and for importing, it’s USD 100 per device.
How Long Does It Last?
Your test license will be valid for three years from the date it’s issued. But be careful — if you break the rules, your license could get canceled.
What Are the Benefits?
Getting a test license isn’t just about following the rules; it can help your business in many ways. It lets you innovate while sticking to the rules, test your products before launching them, and train your staff before starting full-scale production.
Why Choose RSI?
If you need help navigating the process of getting a test licence, Regulatory Solutions India (RSI) is here for you. They’re experts in helping companies with all aspects of the process, from filling out forms to making sure you meet all the requirements.
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