Get MD 5 License for Medical Device Manufacturing in India

MD 5 License is mandatory for companies involved in the manufacturing of Class A and Class B medical devices in India. Under the Medical Device Rules, 2017, businesses manufacturing low-risk and low to moderate-risk medical devices must obtain a valid manufacturing license from the State Licensing Authority. The application is submitted through Form MD 3, and after successful verification and inspection, the authority grants the MD 5 License.

If you are planning to start a medical device manufacturing business in India, obtaining an MD 5 manufacturing license, complying with CDSCO medical device regulations, and meeting ISO 13485 standards are essential for legal operations. At PSR Compliance, we help manufacturers complete the entire CDSCO licensing process smoothly with proper documentation, regulatory support, and expert guidance.

What is MD 5 License?

MD 5 License is a manufacturing license issued for Class A and Class B medical devices under the Medical Device Rules, 2017. This license is granted by the State Licensing Authority after verifying the manufacturing facility, technical documents, and quality management system.

Without an MD 5 License, a company cannot legally manufacture or sell Class A and Class B medical devices in India.

The license ensures that medical devices manufactured in India meet safety, quality, and regulatory standards prescribed by CDSCO.

What is Form MD 3?

Form MD 3 is the application form used for applying for the manufacturing license of Class A and B medical devices in India.

Manufacturers must submit Form MD 3 along with required documents, fees, and compliance details on the CDSCO SUGAM Portal.

Once the application is reviewed and approved, the authority grants the manufacturing license under Form MD 5.

Difference Between MD 3 and MD 5

MD 3 is used for applying, while MD 5 is the final approval certificate.

About Class A & Class B Medical Devices

Medical devices are classified based on risk level under Medical Device Rules, 2017.

Class A Medical Devices

These are low-risk devices with minimal impact on patient safety.

Examples:

• Surgical gloves

• Bandages

• Thermometers

• Tongue depressors

Class B Medical Devices

These devices carry low to moderate risk.

Examples:

• Syringes

• Hypodermic needles

• Infusion sets

• Suction equipment

Importance of Medical Device Classification

Medical device classification is important because it helps regulators apply proper safety controls based on device risk.

Key Benefits of Classification

• Ensures patient safety

• Maintains product quality

• Helps regulatory monitoring

• Improves compliance management

• Supports global regulatory alignment

Higher-risk devices require stricter regulatory review and compliance.

Regulatory Framework for MD 5 License

The manufacturing of medical devices in India is regulated under:

• Drugs and Cosmetics Act, 1940

• Medical Device Rules, 2017

• CDSCO Guidelines

• ISO 13485 Quality Standards

Role of CDSCO

Central Drugs Standard Control Organisation regulates medical devices in India and monitors compliance, licensing, and quality standards.

Role of State Licensing Authority

The State Licensing Authority grants manufacturing licenses for Class A and Class B medical devices.

Role of Notified Bodies

Notified bodies inspect manufacturing premises and verify compliance with quality management systems.

Who Can Apply for MD 5 License?

The following entities can apply:

• Medical device manufacturers

• Startups manufacturing medical devices

• Indian companies manufacturing Class A or B devices

• Contract manufacturers

• Proprietorship firms

• LLPs and Private Limited Companies

Applicants must have a proper manufacturing setup and technical compliance.

Why is MD 5 License Important?

Obtaining an MD 5 License offers multiple business and legal advantages.

Benefits of MD 5 License

Legal Manufacturing Authorization

Allows lawful manufacturing of medical devices in India.

Builds Market Trust

Enhances credibility among hospitals, distributors, and buyers.

Ensures Regulatory Compliance

Helps businesses comply with CDSCO regulations.

Easy Market Expansion

Supports government tenders and export opportunities.

Better Product Acceptance

Certified products gain higher customer confidence.

Documents Required for MD 5 License

The following documents are generally required:

• Form MD 3

• ISO 13485 Certificate

• Site Master File

• Device Master File

• Manufacturing Layout

• List of Equipment

• List of Technical Staff

• Product Details

• Test Reports

• Quality Management Documents

• Constitution Certificate of Company

• GST Certificate

• Electricity Bill

• Authorization Letter

• Fee Payment Challan

Proper documentation plays a major role in fast approval.

Eligibility Criteria for MD 5 License

To obtain MD 5 License, applicants must fulfill the following conditions:

Quality Management System

The company should implement ISO 13485 standards.

Manufacturing Infrastructure

Adequate facility, machinery, and testing arrangements are required.

Technical Staff

Qualified technical professionals must supervise manufacturing activities.

Product Compliance

Medical devices should meet applicable safety and performance standards.

Step-by-Step Procedure for MD 5 License

Step 1: Device Classification

Identify whether the device falls under Class A or B category.

Step 2: Documentation Preparation

Prepare Site Master File, Device Master File, and quality documents.

Step 3: SUGAM Portal Registration

Create login credentials on CDSCO SUGAM Portal.

Step 4: Submission of Form MD 3

Submit application with all required documents.

Step 5: Payment of Government Fees

Pay applicable fees online.

Step 6: Technical Review

Authority reviews submitted documents.

Step 7: Inspection by Notified Body

Manufacturing facility inspection is conducted.

Step 8: Compliance Closure

If any observation is raised, corrective action must be submitted.

Step 9: Grant of MD 5 License

After successful verification, MD 5 License is issued.

Government Fees for MD 5 License

As per Medical Device Rules, 2017:

• ₹5000 for manufacturing site inspection

• ₹500 per medical device

Additional professional and audit fees may apply separately.

Validity of MD 5 License

The MD 5 manufacturing license remains valid perpetually subject to payment of retention fees every 5 years.

Failure to pay retention fees may lead to license suspension.

Timeline for MD 5 License Approval

The approval timeline generally ranges between:

4 to 6 Months

The actual timeline depends on:

• Documentation quality

• Product category

• Inspection readiness

• Query response time

Penalty for Manufacturing Without MD 5 License

Manufacturing medical devices without a valid license may result in:

• Heavy penalties

• Product seizure

• Legal action

• Business closure

• Cancellation of operations

Therefore, obtaining regulatory approval before manufacturing is mandatory.

Why Choose PSR Compliance?

At PSR Compliance, we provide complete support for CDSCO medical device licensing.

Our Services Include

• Device Classification Support

• MD 3 Application Filing

• Documentation Preparation

• ISO 13485 Assistance

• SUGAM Portal Handling

• Query Management

• Audit Preparation

• Compliance Support

Our experts ensure a smooth and hassle-free licensing process.

Frequently Asked Questions (FAQs)

1. What is MD 5 License?

MD 5 License is a manufacturing license issued for Class A and B medical devices in India.

2. Who issues the MD 5 License?

The State Licensing Authority issues the MD 5 License under Medical Device Rules, 2017.

3. Is MD 5 License mandatory?

Yes, it is mandatory for manufacturing Class A and B medical devices legally in India.

4. What is Form MD 3?

Form MD 3 is the application form used for applying for MD 5 License.

5. What is the validity of MD 5 License?

The license remains valid perpetually subject to payment of retention fees every 5 years.

6. How long does it take to get MD 5 License?

Usually, it takes around 4 to 6 months.

7. Is ISO 13485 required for MD 5 License?

Yes, ISO 13485 certification is generally required.

8. Can startups apply for MD 5 License?

Yes, startups and new manufacturers can apply if they fulfill compliance requirements.

9. What happens if manufacturing starts without license?

The company may face penalties, legal action, and product seizure.

10. Can PSR Compliance help with MD 5 License?

Yes, PSR Compliance provides complete assistance for MD 5 License approval.

Conclusion

Obtaining an MD 5 License is an important legal requirement for manufacturing Class A and Class B medical devices in India. The license ensures that medical devices meet safety, quality, and regulatory standards prescribed under Medical Device Rules, 2017. Businesses planning to manufacture medical devices must complete proper CDSCO registration, documentation, inspection, and compliance procedures before starting operations.

With proper professional guidance, the licensing process becomes faster and easier. PSR Compliance helps businesses obtain MD 5 License smoothly with complete regulatory support, expert consultation, and end-to-end compliance services.

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.