Device Master File (DMF) for Medical Devices
A Device Master File (DMF) is a key regulatory document required by CDSCO under MDR 2017. This Device Master File (DMF) includes complete technical data to demonstrate the safety, quality, and performance of a medical device.
Importance of Device Master File (DMF):
- Required for device registration and import license
- Ensures compliance with MDR 2017
- Supports technical review and risk assessment
- Used during audits and inspections
Device Master File (DMF) Checklist:
- Executive summary and device details
- Sterilization and risk management data
- Clinical evidence and regulatory approvals
- Device description and specifications
- Labeling (IFU, brochures, labels)
- Design and manufacturing information
- Risk analysis and control measures
- Verification, validation, and post-market data
A Device Master File (DMF) ensures regulatory compliance, safety, and successful approval of medical devices in India.