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Device Master File

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Device Master File

Device Master File means detailed information concerning the product which is to be submitted to relevant regulatory authority made in accordance with the requirements of Part III, Appendix I of medical device rule 2017.

The device master file shall be prepared by the medical device manufacturer for each medical device or medical device category and must be presented in such a way that it is clear, organized, readily searchable, and unambiguous, to demonstrate the safety and performance of medical device.

The device master file has to be prepared for all the classes of medical device – Class A, Class B, Class C and Class D and the files have to be submitted to CDSCO for review.

Indian-mdr-img

Contents of Device Master File:

CHAPTER 1

1. Executive Summary

  • Device Description- intended use, indication for use, classification, shelf life
  • Sterilization information
  • Risk Management
  • Clinical Evaluation
  • Design examination certificate, declaration of conformity
  • Marketing history
  • Domestic Price
  • List of regulatory approvals
  • Safety and performance related information

CHAPTER 2

2. Device description and product specifications

2.1. Descriptive information

  • General descriptions
  • Intended patient population and medical conditions
  • Principle of operation or mode of action
  • Novel features
  • Description of accessories
  • Configurations and variants
  • Description of key functional elements
  • Description of materials incorporated
  • Information on radiation source

2.2. Product Specification

2.3. Reference to the previous or similar generation of device

CHAPTER 3

3. Labelling

  • Original Label and Packaging Configuration
  • Instruction for use
  • Product Brochure
  • Product Material

CHAPTER 4

4. Design and Manufacturing Information

4.1. Device Design

4.2. Manufacturing Process
 
 

CHAPTER 5

5. Essential Principle Checklist
 

CHAPTER 6

6. Risk Analysis and Control Summary

CHAPTER 7

7. Verification and Validation

7.1. General

7.2. Biocompatibility

7.3. Medicinal Substance

7.4. Biological Safety

7.5. Sterilization

7.6. Software verification and validation

7.7. Animal studies

7.8. Stability Data

7.9. Clinical Evidence

7.10. Post Marketing Surveillance Data

Batch Release Certificate
Certificate of Analysis

Want to prepare a Device Master File as per the requirement of Indian MDR 2017?

If your answer is yes, you probably have lots of questions about the preparation of device master files.

We at Maven Profcon Services LLP, shall give you all the answers.

Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.

Our regulatory consultants help you in identifying requirements as per Indian MDR 2017, helps in clinical evaluation and also in post-marketing activities, risk analysis, and quality management implementation.
 
 
 

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