CDSCO Device Master File for Medical Devices
The Device Master File for Medical Devices is a comprehensive and confidential document to provide technical information about the products to regulatory authorities. This document serves as a critical reference during the regulatory review process, enabling authorities to assess the safety, effectiveness, and quality of the medical devices intended for use in the market.
The Device Master File (DMF) Medical Device includes a wide range of essential information, including device description, product specifications, labelling details, design, manufacturing processes, risk analysis, and validation data. It highlights compliance with essential principles, biocompatibility, sterilization procedures, software verification, stability data, clinical evidence, and post-marketing surveillance.
In this blog, we explore the significance and essential contents of the Device Master File for Medical Devices required to be submitted to the Central Licensing Authority (CDSCO) and State Licensing Authorities for Medical Device Licensing purpose. By understanding the purpose and contents of the DMF, manufacturers can streamline the regulatory approval process and compliance with regulatory requirements for their medical devices.
1. Applicable Regulations for Device Master File
All manufacturers and importers of medical devices are required to submit the Device Master File in accordance with Appendix II of the Medical Device Rule, 2017. This mandatory submission ensures compliance with regulatory guidelines and provides comprehensive technical information essential for obtaining the medical device license.
The content of the Device Master File includes various sections, each covering specific aspects of the medical device. Here’s a summary of the key sections of the Device Master File.
2.1 Executive Summary
The executive summary is a crucial component of the Device Master File for Medical Devices. It provides an overview of key information about the device and its regulatory status. It begins with introductory descriptive information, detailing the medical device’s intended use, indication for use, classification, novel features, and shelf life.
Additionally, the summary highlights essential aspects, such as information on device sterilization (sterile or non-sterile) and the mode of sterilization. It includes a comprehensive risk management plan, risk analysis, and evaluation documents to demonstrate how potential risks associated with the device have been identified, assessed, and controlled.
In the context of clinical evidence, if applicable, it outlines the evidence and evaluation pertaining to the device’s safety and performance. The regulatory status of a similar device in India is also mentioned, indicating whether it has been approved, not approved, or pending clearance in the country.
Additionally, the summary presents certificates related to design examination, declaration of conformity, mark of conformity, and design certificate (if applicable). These certificates validate the device’s compliance with applicable standards and regulations.
The executive summary concludes with essential safety and performance-related information. If the device contains animal or human cells, tissues, or derivatives, the summary provides descriptive information on these components.
2.2 Device description and product specification, including variants and accessories
2.2.1 Device description and product specification, including variants and accessories
The Device Master File must contain descriptive information for the medical device, including its generic name, model name, model number, materials of construction, intended use, indications, instructions for use, contraindications, warnings, precautions, and potential adverse effects.
It should cover the intended patient population, mode of action (with animations or videos if available), explanations of any novel features, descriptions of accessories and other products intended for use with the device, configurations or variants available, details of key functional elements, and complete chemical, biological, and physical characterization of materials.
For medical devices emitting ionizing radiation, information about radiation sources and materials used for shielding must be provided.
2.2.2 Product Specification
The Device Master File should include a comprehensive list of the medical device’s features, dimensions, and performance attributes, along with those of its variants and accessories. This information is typically found in the product specification available to end-users through brochures, catalogues, and other informational materials.
2.2.3 Reference to predicate device
The Device Master File should include details about the manufacturer’s previous device generation, if applicable, as well as information on predicate devices available locally and internationally. Additionally, a comparative analysis must be conducted to establish substantial equivalence to the claimed predicate device(s).
The Device Master File should include a comprehensive set of labeling materials associated with the medical device, which consists of a copy of the original label of the device (including any accessories) and its packaging configuration, instructions for use, as well as product brochures and promotional materials.
2.4 Design and Manufacturing Information
2.4.1 Device Design
The Device Master File should contain information to allow the licensing authorities to obtain a general understanding of the design stages applied to the device. The information may take in form of flow chart. The Device Design Validation data should be submitted.
2.4.2 Manufacturing Processes
The Device Master File should contain information to obtain a general understanding of the manufacturing processes. The information may be provided in the form of flow chart showing an overview of production, manufacturing environment, facilities and controls used for manufacturing, assembly, any final product testing, labelling and packaging and storage of the finished medical device.
2.5 Essential Principles Checklist
The Device Master File should include:
(i) The essential principles and their applicability to the device, with reasons if not applicable.
(ii) Methods used to demonstrate conformity, such as conformity with standards, in-house tests, pre-clinical and clinical evidence, or comparison to similar devices in the market.
(iii) The checklist should cross-reference evidence within the manufacturer’s technical documentation and the dossier to validate conformity with the essential principles.
2.6 Risk Analysis and Control Summary
The Device Master File should include a concise overview of the risks identified during the risk analysis process for the medical device, along with the measures taken to control these risks to an acceptable level. The manufacturer should follow the ISO 14971:2022 for conducting the Risk Analysis.
2.7 Verification and Validation of the Medical Device
The Device Master File should include a concise overview of the risks identified during the risk analysis process for the medical device, along with the measures taken to control these risks to an acceptable level. The manufacturer should follow the ISO 14971:2022 for conducting the Risk Analysis.
2.7.1 General
The Device Master File should include product verification and validation documentation, summarizing results from engineering tests, laboratory tests, simulated use testing, animal tests, and relevant published literature. The summary information may include declarations or certificates of conformity to recognized standards or published standards, with rationales provided.
2.7.2 Biocompatibility
The Device Master File should provide a list of all materials in direct or indirect contact with the patient or user. If biocompatibility testing has been conducted, detailed information on the tests, standards applied, test protocols, data analysis, and results should be included.
2.7.3 Medicinal Substances
If the medical device incorporates a medicinal substance, the device master file should provide detailed information concerning that medicinal substance, its identity and source, the intended reason for its presence, and its safety and performance in the intended application.
2.7.4 Biological Safety
The Device Master File should include a list of all materials of animal or human origin used in the device, with detailed information on their selection, harvesting, processing, preservation, testing, and handling. Process validation results must be provided to ensure manufacturing procedures minimize biological risks, especially concerning viruses and other transmissible agents. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) Certificates should also be submitted. Additionally, the dossier should fully describe the system for record-keeping, allowing traceability from sources to the finished device, ensuring accountability and safety measures are in place.
2.7.5 Sterilization
If the device is supplied sterile, the device master file should include detailed information on the initial sterilization validation. This information should cover sterilizer qualification, bioburden testing, pyrogen testing, testing for sterilant residues (if applicable), and packaging validation, all conducted according to prescribed standards.
2.7.6 Software Verification and Validation
The DMF should include information on the software design and development process, along with evidence of software validation as applied in the finished device. This information should encompass a summary of all verification, validation, and testing conducted in-house and in simulated or actual user environments before final release. It should address different hardware configurations and, if relevant, operating systems mentioned in the device’s labeling.
2.7.7 Animal Studies
If animal studies have been conducted to demonstrate conformity with the Essential Principles concerning functional safety and performance, the DMF should include detailed information about these studies. This information should cover study objectives, methodology, results, analysis, and conclusions, documenting adherence to Good Laboratory Practices (GLP).
2.7.8 Stability Data
The Device Master File should include stability data to support the claimed shelf life of the medical device. If available, real-time aging data should be provided. In the absence of real-time data, accelerated stability data can be submitted to support the claimed shelf life on a provisional basis.
2.7.9 Clinical Evidence
The DMF must provide clinical evidence that establishes the device’s conformity with the Essential Principles relevant to its use. If there is a predicate device available, the manufacturer should submit a substantial equivalence evaluation along with relevant published literature, demonstrating how the device compares to the predicate device in terms of safety and performance.
2.7.10 Post-Marketing Surveillance Data
The DMF of Medical Device should include Post-Marketing Surveillance or Vigilance Reporting procedures, along with the data collected by the manufacturer regarding complaints received after the device has been introduced to the market.
2.8 Batch Release Certificate
The manufacturer should submit Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 consecutive batches.
2.9 Conclusion
In conclusion, the Device Master File for Medical Devices plays a vital role in obtaining regulatory approval and ensuring compliance with essential principles and guidelines. This comprehensive document provides critical technical information to regulatory authorities, allowing them to evaluate the safety, effectiveness, and quality of medical devices intended for use in the market. By adhering to the guidelines outlined in this guide, manufacturers can streamline the regulatory approval process and enhance their chances of obtaining the medical device license.
For manufacturers and importers of medical devices, it is essential to prioritize the creation of a robust and accurate Device Master File. Remember, a well-prepared and thorough Device Master File is a key asset in securing the trust of regulatory authorities and gaining market access for your medical devices.
Looking to prepare your Device Master File and secure your Medical Device Manufacturing License or Import License?
Look no further than MedDev Experts! As a leading Medical Device consulting company, we specialize in providing comprehensive guidance and support throughout the regulatory compliance process.
Our team of experts will assist you in compiling a well-structured and compliant Device Master File, ensuring all essential sections and data are included. We will navigate you through the complexities of regulatory requirements, streamlining the approval process and maximizing your chances of success.
Contact MedDev Experts today and let our experienced team guide you towards obtaining your Medical Device License and Import License with confidence. Your success is our priority!
2.10 Template of Device Master File
LOOKING FOR A READY-MADE DEVICE MASTER FILE TEMPLATE FOR YOUR MEDICAL DEVICE?
Look no further! Contact MedDev Experts today and get access to our comprehensive collection of Device Master File templates tailored to meet your specific regulatory requirements. Streamline your compliance process and save valuable time with our expertly crafted templates. Don’t miss out on this opportunity – reach out to us now and accelerate your path to regulatory approval!
Hi~
I want to get an DMF templates. Can you give me a quote or help?
We would be more grateful if you could send us a limited sample.
Thank you~
Hello John Lee,
We have send you the details to your email. Please feel free to contact us for any further information required.
Regards
Team MedDev Experts