Class II application content and classifications guidance: Submission context
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Chapter 2: Submission context
Folder name: 2-CONTEXT
Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.
2.04 Device description
Folder name: 2.04-DeviceDescription
IMDRF common content
No content at this level.
Classification
New licence applications: Optional but recommended
Amendment licence applications: Optional but recommended
2.04.04 Reference and comparison to similar and/or previous generations of the device (nIVD)
Folder name: 2.04.04-Ref-ComparisontoSimilarand-orPreviousGen
2.04.05 Reference and comparison to similar and/or previous generations of the device (IVD)
Folder name: 2.04.05-Ref-ComparisontoSimilarand-orPreviousGen
IMDRF common content
- A list of similar devices (available on local and international market) and/or previous generation of the devices (if existent) relevant to the submission. This should include any similar/previous generation devices that were previously reviewed and refused by the subject regulator
- Description of why they were selected
- A key specification comparison, preferably in a table, between the references (similar and/or previous generation) considered and the device
IMDRF Health Canada content
- If the application is an amendment to a licensed device or is based on a modification of a licensed device, a description of the modifications is required (for example, changes in design, performance, and indications).
- Comparisons can be used to support the safety and effectiveness of the device if they are made to a currently licensed device in Canada. If this method is used, ensure the Canadian Medical Device Licence Number of the comparator is stated.
Health Canada guidance
When adding a device identifier, comparative information is necessary to validate compliance with licence type requirements. Include a comparison table that outlines all differences between the devices represented by the new identifiers and a closely related licensed comparator(s). For each difference identified, include information that explains why the new identifiers are part of the licence's designated licence type.
Classification
New licence applications: Optional
Amendment licence applications: Conditionally required – When the change is to add a device identifier