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Class A and B Medical Device Manufacturing
Registration in India – MD9

Seamless MD-9 Licensing for High-Risk Medical Devices

Expert guidance and end-to-end support to help you manufacture Class C & D medical devices in full regulatory compliance.

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What is MD9?

MD-9 is the official manufacturing license required for Manufacturing Class C & D medical devices in India, as mandated by the Medical Devices Rules, 2017 (MDR 2017). Class C & D devices are moderate to high-risk, including critical diagnostic, therapeutic, and life-supporting products. 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 9 is 5-6 months.

Why is MD-9 licensing important?

  • Mandatory for product commercialization in India.
  • Builds trust through consistent quality and regulatory compliance.

Quick facts

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

Services We Offer Under MD9

Break down your offerings as a list or grid:

  • Device Classification Assistance and dossier preparation.
  • Preparation & Submission of MD-9 Application.
  • Support in Establishing Quality Management System (ISO 13485)
  • Audit Readiness Support
  • Technical Documentation Preparation (Device Master File, Plant Master File)
  • CDSCO Query Handling

Struggling with MDR compliance? Let Medfins guide
you through.

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Why Choose Medfins for MD9 Compliance?

  • Proven Expertise in high-risk device licensing
  • Comprehensive Support from assessment to approval
  • Dedicated QMS and Technical Team
  • Faster Turnaround with precision documentation
  • Deep Expertise in Medical Device Licensing
  • Proven Track Record in Helping Startups and Established Firms

Step-by-Step Process

Visual timeline or steps:

  • Initial Device Assessment
  • Gap Analysis
  • Documentation Preparation
  • Review & Validation
  • Submission Support
  • Audit Coordination
  • Query Resolution
  • Grant of license after successful verification of query response/ product compliance

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

Whether a separate fee is required for multiple Brands of a device applied for grant of manufacturing or import licence?

Yes, a separate fee is required to be submitted for each applied Brands of a device as per Second Schedule of MDR-2017.

For Class C and Class D medical device, the inspection will be carried out by the Medical Device Officers within a period of 60 days from the date of application, provided the data submitted by the applicant is found satisfactory
The applicant may submit the application to the Licensing authority as under:
1) For Class A & Class B Medical Devices – approach the State Licensing Authority under whose jurisdiction, the manufacturing premises is located.
2) For Class C & Class D Medical Devices – Central Licensing Authority

For Class B, Class C and Class D medical devices, before grant of the manufacturing licence the audit/inspection of the manufacturing site shall be carried out.

As per the second schedule the applicant needs to submit the applicable fee based on the risk class of the devices.

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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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