Medical Device Licence Application Review
| Fee Category | Description | Fee as of April 1, 2018 | Fee as of April 1, 2019 |
|---|---|---|---|
| Class II - Licence Application | $405 | $414 | |
| Class III - Licence Application | $5,805 | $5,922 | |
| Class III - Licence Application (Near Patient In Vitro Diagnostic Devices) | $9,881 | $10,079 | |
| Class IV - Licence Application | $13,500 | $13,770 | |
| Class IV - Licence Application (Devices that contain human / animal tissue) | $12,594 | $12,846 | |
| Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices) | $23,012 | $23,473 | |
| Class III - Changes in Manufacturing | Changes in manufacturing processes, facility, equipment or quality control procedures | $1,462 | $1,492 |
| Class IV - Changes in Manufacturing | $1,462 | $1,492 | |
| Class III - Significant Changes (not related to Manufacturing) | $5,437 | $5,546 | |
| Class IV - Significant Change (not related to Manufacturing | $6,195 | $6,319 |
- Guidance Document - Fees for Review of Medical Device Licence Applications
- New Class II Medical Device Licence Application Form
- New Class III Medical Device Licence Application Form
- New Class IV Medical Device Licence Application Form
- Class III Medical Device Licence Amendment Application Form
- Class IV Medical Device Licence Amendment Application Form
- Guidance Document - How to Complete the Application for a New Medical Device Licence
- Guidance Document - Private Label Medical Devices
- Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
- Private Label Medical Devices: Questions and Answers
- Application for a New Medical Device Licence for a Private Label Medical Device - Form
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