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