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Class A and B Medical Device Manufacturing
Registration in India – MD5

"Achieve Seamless MD-5 Manufacturing Licensing for Class A & B Medical Devices"

Secure your manufacturing license for Class A & B medical devices in India with Medfins' expert guidance and streamlined support, ensuring full CDSCO compliance

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What is MD5?

The MD-5 license is a mandatory certification granted under the Medical Device Rules, 2017, allowing manufacturers to produce Class A and Class B medical devices in India.
It ensures that the manufacturing processes, quality systems, and infrastructure comply with national regulatory standards to guarantee device safety and efficacy.

Timeline

Processing time for MD 5 is 4-5 months.

Why is MD-5 licensing important?

  • Demonstrates regulatory compliance.
  • Enhances product credibility and market acceptance.
  • Ensures patient safety and product reliability.
  • Mandatory for manufacturing and selling medical devices in India

Quick facts

License is issued by the State Licensing Authority (SLA).
Requires compliance with ISO 13485:2016 quality standards.

Services We Offer Under MD5

Break down your offerings as a list or grid:

  • Regulatory Consultation and License Eligibility Check
  • Preparation & Submission of MD-5 Application
  • Support in Establishing Quality Management System (ISO 13485)
  • Audit Readiness Support
  • Liaison with State Licensing Authorities and Notified Body
  • Technical Documentation Preparation (Device Master File, Plant Master File)

Struggling with MDR compliance? Let Medfins guide
you through.

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Why Choose Medfins for MD5 Compliance?

  • Deep Expertise in Medical Device Licensing
  • End-to-End Regulatory Support for Class A & B Devices
  • Fast-Track Documentation and Submission Process
  • Strong Focus on Quality and Compliance
  • Proven Track Record in Helping Startups and Established Firms

Step-by-Step Process

Visual timeline or steps:

  • Initial Device Assessment
  • Collection of technical and legal information / documents from the manufacturer
  • Gap Analysis
  • Documentation Preparation
  • Review & Validation
  • Submission Support
  • Audit Coordination
  • Resolve the queries raised by the authorities
  • Obtain MD-5

The forms required for Manufacturing License in case of class A and B notified medical devices:

Applicant type

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

Fee Structure:

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

FAQ

Who are the competent body to audit the manufacturing facility of Class A & Class B medical devices in the country?
Only those Notified body who are registered with the CDSCO are eligible for audit the manufacturing facility of Class A & Class B medical devices in the country.
Yes, a separate fee is required to be submitted for each applied Brands of a device as per Second Schedule of MDR-2017.

The fee as specified in Second Schedule of MDR-2017 is payable to the State Licensing Authority, through a challan or by electronic mode as may be specified by the State Government concerned.

The applicant may submit the application to the Licensing authority as under: For Class A & Class B Medical Devices – approach the State Licensing Authority under whose jurisdiction, the manufacturing premises is located.

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Get the care you deserve

With our expertise and commitment, you can expect exceptional support for all your regulatory compliance needs.
How this works?
  • Fill out the registration form
  • Schedule a consultation
  • Meet with our regulatory expert
  • Receive tailored guidance
  • Make payment online or via invoice
  • Your project will be initiated by our Executive team

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