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.
Contents of Device Master File:
CHAPTER 11. Executive Summary
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CHAPTER 22. Device description and product specifications 2.1. Descriptive information
2.2. Product Specification 2.3. Reference to the previous or similar generation of device |
CHAPTER 33. Labelling
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CHAPTER 44. Design and Manufacturing Information 4.1. Device Design 4.2. Manufacturing Process |
CHAPTER 55. Essential Principle Checklist |
CHAPTER 66. Risk Analysis and Control Summary |
CHAPTER 77. 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 |
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