Importing medical devices into India requires strict compliance with regulations set by the Central Drugs Standard Control Organisation (CDSCO). For Class C and Class D medical devices, one of the most critical requirements for obtaining the MD-15 import licence is the preparation and submission of DMF (Device Master File) and PMF (Plant Master File). These two documents together help CDSCO evaluate the safety, quality, performance, and manufacturing controls of the medical device and its manufacturing site. Any error or gap in DMF or PMF documentation is one of the most common reasons for MD-15 delays or rejections.
This guide explains DMF PMF medical device CDSCO MD-15 Import Licensing in simple words, covering their purpose, structure, preparation process, common mistakes, and best practices.
What Are DMF and PMF Under CDSCO?
- Device Master File (DMF) – The Device Master File (DMF) contains complete technical and safety information about the medical device itself. It explains how the device is designed, how it works, what materials are used, and how its safety and performance are validated.
- Plant Master File (PMF) – The Plant Master File (PMF) provides detailed information about the manufacturing facility where the medical device is produced. It focuses on quality systems, manufacturing controls, infrastructure, and compliance with Quality Management System requirements under MDR 2017 (ISO 13485-based).
DMF & PMF are key documents submitted as part of MD-14/MD-15 import licence applications, especially for higher-risk devices (Class C/D), and may also be required (to a limited extent) for certain Class A and Class B devices where import licensing applies.
Why DMF and PMF Are Mandatory for MD-15 Import Licence?
CDSCO uses DMF and PMF to ensure that:
- The device is safe and effective for Indian patients
- Manufacturing follows international quality standards
- Risks are properly identified and controlled
- Imported devices meet Medical Device Rules (MDR), 2017
Without properly prepared DMF and PMF documents, CDSCO will not grant MD-15 approval.
Applicability of DMF and PMF in MD-15 Import License
DMF and PMF are required when:
- The medical device is imported into India
- The device falls under Class C or Class D
- An MD-15 import licence is being applied for
- The manufacturer is located outside India
For devices that require an import licence, the Indian Authorised Agent applies in Form MD-14, and CDSCO grants the MD-15 import licence after approval.
Structure of Device Master File (DMF)
The DMF must be prepared in a structured and systematic format as prescribed under CDSCO guidance. It generally includes:
1. General Device Information
- Device name and model details
- Intended use and indications
- Device classification (Class C or D)
- Global regulatory approvals (if any)
2. Device Description
- Design features
- Components and accessories
- Principle of operation
- Variants and configurations
3. Design and Manufacturing Information
- Manufacturing process flow
- Raw materials used
- Quality control checks
4. Essential Principles of Safety and Performance
- Risk analysis and mitigation
- Compliance with applicable standards
- Performance validation data
5. Verification and Validation Data
- Electrical safety (if applicable)
- Biocompatibility reports
- Sterilisation validation
- Software validation (if applicable)
6. Labelling and IFU
- Labels proposed for India
- Instructions for Use (IFU)
- Symbols and warnings
Structure of Plant Master File (PMF)
The PMF focuses on the manufacturing site and quality system and usually includes:
1. General Plant Information
- Manufacturer’s name and address
- Manufacturing site location
- Type of devices manufactured
2. Quality Management System
- ISO 13485 certification details
- Quality policy and objectives
- Document control system
3. Manufacturing Infrastructure
- Facility layout
- Equipment used
- Environmental controls
4. Quality Control and Assurance
- Incoming material checks
- In-process quality control
- Final product release procedures
5. Sterilisation and Validation (If Applicable)
- Sterilisation method
- Validation reports
- Revalidation frequency
6. Complaint Handling and CAPA
- Complaint management system
- Corrective and preventive actions
- Product recall procedures
How DMF and PMF Are Submitted for MD-15 Import License?
The Indian Authorised Agent or Importer submits DMF and PMF through the CDSCO SUGAM portal as part of the MD-15 application.
The submission process includes:
- Uploading DMF and PMF in the prescribed format
- Linking documents with device models
- Responding to CDSCO technical queries
- Providing clarifications or revised documents if required
Proper document alignment between DMF and PMF is essential to avoid objections.
Common Mistakes in DMF and PMF Submissions
Some frequent issues that delay MD-15 approval include:
- Mismatch between DMF and PMF information
- Outdated ISO 13485 certificates
- Missing risk management documents
- Incomplete sterilisation validation data
- Incorrect device classification
- Non-India compliant labelling
Avoiding these mistakes significantly improves approval timelines.
Best Practices for Faster MD-15 Approval
To ensure smooth DMF PMF medical device CDSCO MD-15 import license approval, it is recommended to:
- Prepare documents strictly as per MDR 2017
- Use updated and consistent technical data
- Ensure all test reports are from accredited labs
- Keep documents India-specific
- Engage experienced regulatory professionals
Why Choose ELT Corporate?
ELT Corporate provides end-to-end support for DMF and PMF preparation and MD-15 import licence approval, including:
- Accurate device classification
- Professionally structured DMF and PMF documents
- CDSCO query handling
- End-to-end SUGAM portal support
- Ongoing regulatory compliance assistance
Their regulatory expertise helps reduce approval delays and compliance risks.
Conclusion
DMF and PMF are the backbone of MD-15 import licence for medical devices in India. These documents allow CDSCO to assess the safety, quality, and manufacturing integrity of imported medical devices. Preparing them correctly, clearly, and in line with current regulations is essential for successful approval. For manufacturers and importers, understanding DMF and PMF requirements is not optional; it is a critical regulatory responsibility under India’s medical device framework.
Are DMF and PMF mandatory for all medical devices?
They are mandatory for imported Class C and D medical devices applying for MD-15.
Can the same PMF be used for multiple devices?
Yes, if all devices are manufactured at the same facility.
Is ISO 13485 compulsory for PMF submission?
Yes. A valid ISO 13485 certificate or equivalent QMS evidence is required as part of PMF/QMS compliance, especially for Class C and D devices.
Can overseas test reports be accepted in DMF?
Yes, if they are from accredited laboratories and relevant to the device.
Who submits DMF and PMF to CDSCO?
The Indian Authorised Agent or importer submits them via the SUGAM portal.
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