Recently, Health Canada announced an update to the application and review fee structure for medical device licences. This update covers two main categories: Medical Device Product Licences and Medical Device Establishment Licences (MDEL).
The revised fees will come into effect on April 1, 2026.
I. Medical Device Product Licence Application and Amendment Fees
These fees apply to Class II, Class III, and Class IV medical devices, including new licence applications, licence amendments, and authorization amendments.
| No. | Category | Description | Fee from April 1, 2025 (CAD) | Fee from April 1, 2026 (CAD) |
|---|---|---|---|---|
| 1 | Class II Licence Application | Application for a Class II medical device licence (excluding item 10) | 632 | 643 |
| 2 | Class II Licence Amendment or Authorization Amendment | Amendment to a Class II licence, or an authorization amendment for a Class II medical device (non-UPHN) submitted under section 68.14 of the Medical Devices Regulations (excluding item 10) | 325 | 331 |
| 3 | Class III Licence Application | Application for a Class III medical device licence (excluding items 4 and 10) | 13,926 | 14,163 |
| 4 | Class III Licence Application (Near-Patient IVDs) | Application for a Class III licence for near-patient in vitro diagnostic devices | 29,664 | 30,169 |
| 5 | Class III Licence Amendment or Authorization Amendment – Manufacturing-Related Changes | Amendment to a Class III licence, or authorization amendment under section 68.14 for a Class III medical device (non-UPHN), involving changes to manufacturing processes, facilities, equipment, or quality control procedures | 4,395 | 4,470 |
| 6 | Class III Licence Amendment or Authorization Amendment – Major Non-Manufacturing Changes | Amendment to a Class III licence, or authorization amendment under section 68.14 for a Class III medical device (non-UPHN), involving major changes other than those listed in item 5 | 11,178 | 11,369 |
| 7 | Class IV Licence Application | Application for a Class IV medical device licence (excluding item 10) | 30,199 | 30,713 |
| 8 | Class IV Licence Amendment or Authorization Amendment – Manufacturing-Related Changes | Amendment to a Class IV licence, or authorization amendment under section 68.14 for a Class IV medical device (non-UPHN), involving manufacturing-related changes as described in section 34(a) or 68.13(a) of the Medical Devices Regulations | 4,395 | 4,470 |
| 9 | Class IV Licence Amendment or Authorization Amendment – Major Non-Manufacturing Changes | Amendment to a Class IV licence, or authorization amendment under section 68.14 for a Class IV medical device (non-UPHN), involving any other changes described in sections 34(a) or (b), or 68.13(a) or (b) of the Medical Devices Regulations | 15,979 | 16,251 |
| 10 | Class II, III or IV Licence Applications or Amendments – Private Label Devices | Applications, licence amendments, or authorization amendments under section 68.14 for Class II, III or IV private-label medical devices (non-UPHN) | 176 | 179 |
II. Medical Device Establishment Licence (MDEL) Application Review Fee
This fee applies to organizations seeking to conduct medical device sales activities in Canada, including manufacturers, importers, and distributors, that are required to obtain a Medical Device Establishment Licence (MDEL).
| Fee Category | Fee from April 1, 2025 (CAD) | Fee from April 1, 2026 (CAD) |
|---|---|---|
| Medical Device Establishment Licence (MDEL) Application Review Fee | 5,426 | 5,519 |
Key Reminder
All revised fees will officially take effect on April 1, 2026.
Companies planning to submit medical device licence or establishment licence applications in 2026 or later are strongly advised to prepare their budgets and submissions in accordance with the updated fee schedule.