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: [email protected]

Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Website: https://www.psrcompliance.com