The MD-9 License in India is an essential approval under the Indian regulatory framework for medical device manufacturing and compliance. If you are planning to start a medical device business, manufacturing unit, or import-export operation, understanding the MD-9 license is crucial for legal operations in India.
This guide explains everything in simple language including meaning, eligibility, documents, process, fees, and benefits—fully SEO optimized for better ranking.
What is MD-9 License in India?
The MD-9 License is issued under the Medical Device Rules, 2017, regulated by the Central Drugs Standard Control Organization (CDSCO).
It is a loan license for manufacturing medical devices in India. This means a company can manufacture medical devices using another licensed manufacturer’s facility.
👉 In simple words:
MD-9 license allows you to manufacture medical devices without owning a manufacturing plant, by partnering with an already approved facility.
Key Features of MD-9 License
Loan license for medical device manufacturing
Issued by CDSCO authority
Applicable under Medical Device Rules, 2017
Valid across India
Mandatory for regulated medical device production
Required before launching devices in Indian market
Who Needs MD-9 License?
You must apply for MD-9 License if:
You want to manufacture medical devices but don’t own a factory
You plan to outsource manufacturing
You are a startup entering medical device industry
You want to legally sell medical devices in India
You are working in partnership with another licensed manufacturer
Eligibility Criteria for MD-9 License
To apply for MD-9 license, you must meet the following conditions:
✔ Legal Business Entity
Company must be registered (Private Limited / LLP / Firm)
✔ Valid Agreement
Must have agreement with an MD-5 licensed manufacturer
✔ Technical Staff
Qualified technical personnel required for production supervision
✔ Quality System
Compliance with ISO 13485 (recommended/required depending on device class)
✔ Facility Access
Manufacturing will be done in a licensed facility only
Documents Required for MD-9 License
Here is the list of important documents:
Company Incorporation Certificate
GST Registration Certificate
PAN Card of company
MOA & AOA (for Pvt Ltd companies)
Agreement with manufacturing unit (MD-5 holder)
Device details and specifications
Quality Management System documents
ISO certificate (if applicable)
ID & address proof of directors
Technical staff qualification proof
Manufacturing process flowchart
MD-9 License Application Process (Step-by-Step)
Step 1: Company Registration
Register your business as LLP or Private Limited Company.
Step 2: Tie-Up with Manufacturer
Sign agreement with a valid MD-5 licensed manufacturer.
Step 3: Prepare Documents
Collect all technical, legal, and compliance documents.
Step 4: Online Application
Apply through the CDSCO online portal.
Step 5: Upload Documents
Upload all required certificates and agreements.
Step 6: Inspection (if required)
Authorities may inspect documents or manufacturing setup.
Step 7: Approval & License Issuance
Once verified, MD-9 license is issued.
Validity of MD-9 License
Generally valid for 5 years
Renewal required before expiry
Must maintain compliance during entire validity period
Fees for MD-9 License in India
Fees depend on category and device type:
Application fee: ₹5,000 – ₹25,000 (approx.)
Inspection fee (if applicable)
Professional consultancy charges (optional)
Benefits of MD-9 License
Legal authorization to manufacture medical devices
No need to set up manufacturing plant
Fast entry into medical device industry
Helps startups reduce investment cost
Improves credibility in healthcare market
Enables government compliance and approvals
Challenges in MD-9 Licensing
Complex documentation process
Strict compliance requirements
Dependency on MD-5 manufacturer
Technical validation required
Time-consuming approval process
MD-9 vs MD-5 License
Importance of MD-9 License in India
India’s medical device industry is growing rapidly, and government regulation ensures safety and quality. MD-9 license ensures that:
Only approved manufacturers produce medical devices
Quality standards are maintained
Patient safety is protected
Industry compliance is ensured
Common Mistakes in MD-9 Application
Incomplete documentation
Wrong manufacturer agreement
Missing ISO certification
Incorrect device classification
Not following CDSCO guidelines
How PSR Compliance Can Help
Getting MD-9 license can be complex without expert guidance.
PSR Compliance helps you with:
Complete MD-9 license registration
Document preparation and verification
CDSCO application filing
Manufacturer tie-up support
Fast approval process assistance
End-to-end compliance support
FAQs – MD-9 License in India
1. What is MD-9 license used for?
It is used for loan-based manufacturing of medical devices in India.
2. Who issues MD-9 license?
It is issued by CDSCO.
3. Is factory required for MD-9 license?
No, manufacturing is done through another licensed facility.
4. How long does MD-9 approval take?
Generally 30–90 days depending on documentation.
5. Is MD-9 license mandatory?
Yes, if you are manufacturing medical devices through a third-party facility.
Conclusion
The MD-9 License in India is a powerful opportunity for businesses entering the medical device sector without heavy investment in infrastructure. It ensures legal compliance under Indian medical regulations and opens doors to a fast-growing healthcare market.
If you want smooth approval and zero rejection chances, expert guidance is highly recommended.
👉 For hassle-free registration and compliance support, PSR Compliance can help you get your MD-9 license quickly and correctly.
Company Name: PSR Compliance
Phone: +91 7065883416
Email: support@psrcompliance.com
Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301
Website: https://www.psrcompliance.com
