Get Your CDSCO MD-5 LicenseManufacture Class A & B Medical Devices in India
Stop worrying about regulatory compliance. We've helped 500+ manufacturers get their MD-5 license with a 100% success rate. Your medical device business starts here.
What is CDSCO MD-5 License? Complete Guide 2024
Think of the MD-5 License as your golden ticket to manufacturing medical devices in India. It's the government's way of saying "you're qualified to make devices that touch patients' lives." Without it, you're stuck on the sidelines.
Why Now is the Perfect Time
India's medical device market is exploding—projected to hit $50 billion by 2025. Early birds get the worm, and licensed manufacturers get the contracts.
Don't Risk Your Business
Operating without an MD-5 License is like driving without a license—you'll get caught eventually. Fines, recalls, and business shutdowns are real consequences.
Who Needs This License?
How to Get MD-5 License: 5 Simple Steps
We've streamlined the process into 5 clear steps. No confusion, no delays—just results.
Get Your Test License (MD-13)
First, you need permission to test your products. Apply on the NSWS portal. Think of it as a learner permit before your full license. Takes 1-2 months and costs ₹500 per product.
Manufacture & Test Product
Now you can actually make your products and test them. This is where you prove your device works and is safe. Build your samples and gather all the data.
Prepare & Submit MD-3 Application
Time to apply for the real deal. Pay the fees (₹5,000 + ₹500 per product), upload everything, and submit your MD-3 application on the CDSCO portal.
Audit & Department Queries
The inspectors come to check your facility and paperwork. They might ask questions - we help you answer them quickly and correctly.
Get Your License
Congratulations! If everything looks good, you get your MD-5 License. It lasts 5 years and you can renew it without another audit.
MD-5 License Cost & Timeline: What to Expect
Total Timeline: 3 Months
Government Fees
Why Choose Our Services?
MD-5 License Documents Required: Complete Checklist
Don't let missing paperwork slow you down. Here's exactly what you need to gather.
Form MD-3
Official application form for manufacturing Class A & B devices.
Device Master File
Comprehensive technical file detailing device design, materials, and performance.
Site/Plant Master File
Details of your manufacturing facility, equipment, and personnel.
ISO 13485 Certificate
Proof of a certified Quality Management System.
Test License (if applicable)
Required if in-house device testing is performed.
Company Identity Proof
MOA/Partnership Deed, list of Directors/Partners, Sale/Rent Deed.
Certificate of Analysis
For the first three production batches.
Environmental Compliance
Evidence of compliance with environmental regulations, if applicable.
Audit Reports
Internal or prior notified body audits.
Pro Tip
Pro tip: We review every document before submission. Missing paperwork is the #1 reason applications get delayed. Let us catch the issues before the government does.
MD-5 License Compliance: Keep Your Business Safe
Non-Compliance Risks
Failure to maintain compliance can result in license suspension or cancellation. Our team ensures you stay compliant with all regulatory requirements.
Success Tips
Ensure all documentation is accurate and up to date. Incomplete filings are the #1 cause of delays.
Conduct internal mock audits to pre-empt non-conformities and boost team confidence.
Assign a dedicated regulatory team or signatory to manage CDSCO interactions and deadlines.
Respond promptly to authority queries on the SUGAM portal to avoid unnecessary delays.
Keep digital and physical backups of all submissions and correspondence.
"These guys know their stuff. They walked us through every step, caught issues before they became problems, and got us licensed on the first try. Worth every penny."
MD-5 License FAQ: Your Questions Answered
Real questions from real manufacturers. Here are the answers you need.
Who actually needs an MD-5 License?
How long does this whole process take?
What's the biggest reason applications get rejected?
Does the license expire?
What happens after I get the license?
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Book a free 30-minute call to discuss your situation. We'll give you a clear roadmap and honest assessment of what you need to do.
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Join 500+ manufacturers who've already got their license with our help. Your success story starts here.