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MD 5 License to Manufacture Medical Devices in India to Manufacture Class A and Class B Devices

The MD 5 Medical Device Manufacturing License is issued by the State Licensing Authority (SLA) to manufacturers of Class A and Class B medical devices in India. Class A medical devices are those that are considered to be low risk, while Class B medical devices are those that are considered to be of low-moderate risk. The MD 5 License is mandatory for the manufacture, sale, and distribution of Class A and Class B medical devices in India.

What is MD 5 License?

  • MD 5 License is issued by the State Licensing Authority of the concerning state to manufacturers of Class A and Class B medical devices.
  • The MD 5 License is a mandatory requirement for the manufacture, sale, and distribution of Class A and Class B medical devices in India.
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Essential Documents Required for MD 5 License

  • Covering Letter to be addressed to the State Licensing Authority
  • Memorandum of Article / List of Directors or Partners / UDYAM Aadhar / PAN etc.
  • Sale Deed / Rent Deed of the Premises
  • Plant Master File / Site Master File of the Manufacturing Unit
  • Plant Layout with Dimension
  • ISO 13485 Certificate
  • Previous ISO 13485 Notified Body Audit Reports, if any
  • Competent Technical Staff for Manufacturing and Testing of Devices
  • Device Master File as per Appendix II of Medical Device Rule, 2017
  • Test License, if any
  • Compliance with the provision of Fifth Schedule of the MDR
  • Certificate of Analysis of 3 Consecutive Batches
  • Performance Evaluation Report, if any, for IVDs only
Learn more about the key elements of the Device Master File (DMF) here.

How to apply for MD-5 Medical Device Manufacturing License?

  • Go to CDSCO SUGAM Portal
  • Login with your registered Username and Password.
  • Go to Submit Application
  • Choose the MD 3 Manufacturing License
  • Fill out the Device Details
  • Upload the Mandatory Documents for MD 5 License
  • Pay the Prescribed Fee for MD 5 License
Learn more about the Step-by-Step-Guide of Application Process for a Medical Device Manufacturing License
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Are You Looking for MD 5 License to Manufacture Class A and Class B Medical Devices?

Contact ZYPS Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.

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Fee for MD 5 Medical Device Manufacturing License?

The manufacturer of Class A and Class B Devices needs to pay ₹ 5000/- for MD 5 License and ₹ 500/- for each distinct device they manufacture.

Validity of MD 5 License

The MD 5 License issued to manufacture Class A and Class B Medical Devices will remain valid indefinitely, but the licensee must pay the retention fee every five years from the date of issue of the license.

Eligibility Criteria for a Medical Device Manufacturing License in India

  • Must be a legal entity registered in India.

  • Must have a manufacturing facility that complies with the Fifth Schedule of the Medical Device Rule, 2017.

  • Must have the manufacturing facility ISO 13485 or ICMED 13485 certified.

  • Must have the financial stability to meet the fees and expenses associated with the application process and ongoing compliance.

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