Preparing a Device Master File (DMF) as per the Medical Device Rules, 2017: A Guide by Morulaa HealthTech

Morulaa HealthTech, as the leading consultant in India for medical devices, simplifies the preparation of the Device Master File (DMF) in compliance with the Medical Device Rules and regulation (India MDR, 2017). Acting as your authorized agent in India, Morulaa ensures the DMF meets the regulatory requirements of the CDSCO medical device guidelines and is ready for submission through the CDSCO Sugam Portal for medical devices.

Contact Us to get a copy of the CDSCO device master file template for medical devices. This template aligns with medical device regulation in India and will guide you in gathering the essential information required for the regulatory process with the CDSCO.

What is a Device Master File (DMF) in the CDSCO Medical Device Regulatory Process?

A Device Master File(DMF) is a critical regulatory document required by the CDSCO to evaluate the safety, performance, and quality of medical devices. This document is similar to your medical device technical file. DMF plays a vital role in the medical device approval process in India, It consolidates key technical and regulatory details, making it a cornerstone of the CDSCO medical device registration process in India.

How Morulaa Prepares Your Device Master File

Morulaa HealthTech customizes the DMF preparation process to meet CDSCO’s requirements, using your existing technical dossier as the foundation. Here’s how we integrate your data while meeting India-specific regulatory needs:

1. Technical File Review and Consolidation for Medical Device Compliance in India

Morulaa begins by reviewing your medical device technical file to ensure it contains all required information for the CDSCO medical device regulatory process

Expert Tip by Morulaa HealthTech:
Share the Technical File Document for Each Device Family: This document, typically used for EU or FDA submissions, should include the device description, product specifications, materials, and working principles.
Single Combined DMF per Device Family: Ensure all model numbers, accessories, and components mentioned in the MD-14 legal form are also covered in the respective technical files.

This ensures consistency and completeness for every device family being registered under the guidelines of medical device regulations in India.

2. India-Specific Data Collection for Medical Device Regulation

India-specific regulatory requirements go beyond global norms, and Morulaa ensures the DMF is tailored accordingly.

Expert Tip by Morulaa HealthTech:
Fill the Document Labeled “v101_India Specific DMF Information”: This document is available in the folder "1_Introduction_Technical File" and must be completed separately for each device family as per CDSCO medical device classification requirements in India. Case Study: Preparing a Device Master File (DMF) for an EU Manufacturer EU Manufacturer with MDR Approval: The manufacturer had MDR approval under EU regulations. Morulaa requested the Technical Documentation File as per Annex II of MDR to proceed with the preparation. Action Taken: After receiving the Technical Documentation, Morulaa prepared the Schedule DII following the guidelines in Appendix II, Part III, Fourth Schedule of MDR 2017. Outcome: The correctly prepared DMF was submitted and approval received, meeting regulatory standards and ensuring a smooth review process by the authorities.

Expert Tip by Morulaa HealthTech:

Fill the Document Labeled “v101_India Specific DMF Information”: This document is available in the folder "1_Introduction_Technical File" and must be completed separately for each device family as per CDSCO medical device classification requirements in India.

Case Study: Preparing a Device Master File (DMF) for an EU Manufacturer

EU Manufacturer with MDR Approval: The manufacturer had MDR approval under EU regulations. Morulaa requested the Technical Documentation File as per Annex II of MDR to proceed with the preparation.
Action Taken: After receiving the Technical Documentation, Morulaa prepared the Schedule DII following the guidelines in Appendix II, Part III, Fourth Schedule of MDR 2017.
Outcome: The correctly prepared DMF was submitted and approval received, meeting regulatory standards and ensuring a smooth review process by the authorities.

This form captures India-specific details such as safety data, pricing, and compliance requirements that are critical for CDSCO medical device approval process.

3. Create a Executive Summary to Cover Predicate, Key Marketing Information for CDSCO Audit

The DMF includes an executive summary containing:

Marketing History: Details of countries where the device has been launched, the launch dates, and the number of units sold.
Domestic Pricing: Approximate EXW pricing in the country of origin.

Regulatory Approvals: A list of regulatory clearances with their medical device classification, approved indications, shelf life, and any rejections or withdrawals.

4. Device Description and Specifications as per CDSCO Medical Device Guidelines

This section provides detailed information about the device, including:

Variants, accessories, and their functionality.
Material characterizations for components in direct or indirect contact with the human body.
Information on radiation shielding (if applicable).

5. Risk and Safety Data for Medical Device Compliance in India

Morulaa compiles summaries of:

Serious Adverse Events (SAE): Timeline, number of incidents, and affected batches.
Field Safety Corrective Actions (FSCA): Actions taken, affected regions, and reasons for the corrective measures.

6. DMF Creation and Finalization

Morulaa uses the consolidated technical file and India-specific information to create the DMF.

Expert Tip by Morulaa HealthTech:
Review and Sign the Finalized DMF: Once the DMF is prepared, it must be reviewed, signed, and stamped on your company letterhead before submission.

7. Submission of DMF to the CDSCO Sugam Portal for Medical Devices

The finalized DMF is to be uploaded on the CDSCO Sugam Portal for medical devices, ensuring compliance with format and requirements for CDSCO medical device guidelines in India.

Frequently Asked Questions:

Do I need to submit both hard copies and soft copies of the Device Master File (DMF) in India?

No, a soft copy of the DMF is sufficient for submission in India. However the DMF needs to be in a company letterhead and have to be signed by the authorized regulatory person. Ensuring the soft copy is accurate and complete will meet the regulatory requirements.

How long does it usually take to prepare a Device Master File (DMF) for CDSCO medical device registration?

Once all the information is shared to Morulaa the DMF preparation takes 4-5 days and we will prepare the DMF and share it with you for confirmation, making the process seamless and efficient.

Is a DMF required for all MD-14 applications and risk classes of medical devices?

No, the DMF is not required for non-notified applications. However, it is mandatory to create a DMF for devices in the notified categories. Morulaa can help ensure compliance with these requirements.

Why Choose Morulaa HealthTech for Your Device Master File?

Morulaa HealthTech, as one of the best medical device regulatory consultants in India, we offer our expertise in DMF preparation. As your authorized agent in India, we ensure:

Comprehensive DMF Preparation: Leveraging your technical files to create a Device Master File as per Medical Device Rules, 2017, tailored for the CDSCO medical device regulatory process in India.
End-to-End Support: From initial data collection to Sugam Portal submission, we manage the entire process.
Seamless Regulatory Navigation: Addressing all CDSCO queries and compliance needs efficiently, with our experience as one of the top medical device consultants in India.

Conclusion: Ensuring CDSCO Medical Device Registration Process Compliance

By following Morulaa’s expert tips and leveraging our regulatory expertise, manufacturers can ensure efficient preparation and submission of their Device Master File as per the Medical Device Rules, 2017. This facilitates quick market access for medical devices in India. Our focus on medical device regulation in India ensures every step of the process meets compliance requirements.

Contact Us to get a copy of the CDSCO device master file template for medical devices and begin your registration process in India today.