Get Your CDSCO MD-9 LicenseManufacture Class C & D Medical Devices in India
We help you navigate the toughest regulatory path for high-risk medical devices. 100+ manufacturers have secured their MD-9 license with us. Your compliance journey starts here.
What is CDSCO MD-9 License? Complete Guide 2024
The MD-9 License is your official approval to manufacture high-risk (Class C & D) medical devices in India. Without it, you cannot legally produce or sell these critical care products.
Why Now is Critical
India's demand for advanced medical devices is surging. Early compliance means faster market entry and a competitive edge in a $50B+ industry.
Don't Risk Your Business
Manufacturing without an MD-9 License can lead to severe penalties, recalls, and shutdowns. Compliance is not optional for Class C & D devices.
Who Needs This License?
How to Get MD-9 License: 5 Simple Steps
We break down the complex process into 5 clear steps for Class C & D devices.
Get Your Test License (MD-13)
First, you need permission to test your products. Apply on the NSWS portal. This is required before the main application. Takes 1-2 months and costs ₹1,000 per product.
Manufacture & Test Product
Manufacture and test your Class C & D products. Gather all technical and safety data.
Prepare & Submit MD-7 Application
Pay the fees (₹50,000 + ₹1,000 per product), upload all documents, and submit your MD-7 application to CDSCO HQ.
Audit by CDSCO Inspectors
CDSCO Inspectors will audit your facility and documents. Be ready for queries and compliance checks.
Get Your License
If all is in order, you receive your MD-9 License, valid for 5 years and renewable.
MD-9 License Cost & Timeline: What to Expect
Total Timeline: 4-5 Months
Government Fees
Why Choose Our Services?
MD-9 License Documents Required: Complete Checklist
Here is the full list of documents you need for a successful MD-9 application.
Form MD-7
Official application form for manufacturing Class C & D 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
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-9 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-9 License FAQ: Your Questions Answered
Real questions from real manufacturers. Here are the answers you need.
Who needs an MD-9 License?
How long does the MD-9 process take?
What is the biggest reason for rejection?
Does the license expire?
Who conducts the audit?
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