Device Master File
The Device Master File (DMF) under the Central Drugs Standard Control Organization (CDSCO) is a comprehensive document that provides detailed information about a medical device, including its design, manufacturing process, safety, and performance. The DMF is a critical component in the regulatory approval process for medical devices in India, ensuring that devices meet the required standards for safety, efficacy, and quality before they can be marketed and used in clinical settings.
Purpose and Importance of the DMF
The primary purpose of the DMF is to provide the CDSCO with all the necessary information to assess the safety and effectiveness of a medical device. This includes data on the materials used, design specifications, manufacturing processes, quality control procedures, and preclinical and clinical testing results. The DMF is essential for the regulatory review process, as it allows the CDSCO to evaluate whether the device meets the applicable standards and regulations, such as the Medical Device Rules (MDR) 2017.
For manufacturers, the DMF serves as a key document that demonstrates compliance with regulatory requirements. Manufacturers going for a license for their medical devices under CDSCO are required to submit a thorough DMF document of their process. It is a tool for ensuring that all aspects of the device’s development and production are well-documented and controlled, minimising the risk of defects or failures that could compromise patient safety. The DMF also supports the manufacturer’s claims about the device’s performance and helps establish trust with regulatory bodies, healthcare providers, and patients.
The CDSCO provides distinct formats for drafting Device Master Files (DMFs) specific to medical devices and in vitro diagnostic (IVD) devices.
Contents
The fourth schedule of the MDR 2017 covers a detailed explanation as to how to draft and what all information to be enclosed in the DMF.
Device Master File For Medical Devices Other Than In Vitro Diagnostic Medical Devices
- Executive Summary
- Device description and product specification, including variants and accessories
- Labelling Information
- Design and Manufacturing Information
- Essential principles Checklist
- Risk analysis and control summary
- Verification and Validation of the medical device
Device Master File For In Vitro Diagnostic Medical Devices:
- Executive Summary
- Description and specification, including variants and accessories of the in vitro diagnostic medical device
- Essential principles checklist
- Risk analysis and control summary
- Design and manufacturing information
- Product validation and verification
- Analytical Studies
- Specimen type
- Analytical performance characteristics
- Analytical sensitivity
- Analytical specificity
- Metrological traceability of calibrator and control material values
- Measuring range of the assay
- Definition of Assay Cut-off
- Stability (excluding specimen stability)
- Claimed Shelf life
- In use stability
- Shipping stability
- Clinical Evidence
- Labelling
- Post marketing surveillance data (vigilance reporting)
- Information required to be submitted for the in vitro diagnostic medical device