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.
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?
- 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
Are You Looking for MD 5 License to Manufacture Class A and Class B Medical Devices?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
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.
Important Links
- Medical Device License for Class A or B Devices: MD-5
- Wholesale License for Medical Device: MD-42
- Medical Device Test License: MD-13
- Unique Device Identification (UDI)
- Medical Device Labeling Requirements
- US FDA 510(k) Consultant for Medical Devices in India
- Free Sale Certificate for Import and Export of Devices
- Mandatory Documents for MD 5 Manufacturing License
- Risk Management of Medical Devices as per ISO 14971:2019
- Essential Medical Device Symbols for Labeling
- Medical Device License for Class C or D Devices: MD-9
- Medical Device Import License: MD-15
- FDA NDC Number Reservation
- EU Declaration of Conformity
- ISO Certification Consultant in India
- ISO 13485 Certification Consultant in India
- US FDA Establishment Registration and Device Listing
- Medical Equipment Manufacturing License in India
- CDSCO Device Master File for Medical Devices
- Class C-D Medical Devices Under Licensing Regime
