Medical device reports and publications
Under the Food and Drugs Act, medical devices are health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
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Reports and publications
This section contains links to reports and publications related to medical devices, including:
Medical devices performance reports
The medical devices performance reports provide detailed data about the timeliness of pre-market medical devices review process against the performance service standards. Each report is organized by parts of the regulations and the types of applications they include.
The reports include statistics by submission type, showing:
- number received
- number licensed
- number in progress (workload)
- number of decisions made
- time to first decision, measured against cost recovery service standards
Key terms explained
- Applications received:
- The number of submissions received during the reporting period.
- Workload:
- The number of submissions "in process" on a given day.
- Backlog:
- The proportion of the workload that exceeds target timelines. (Note: "Workload" is sometimes confused with the amount of work received, which can cause misunderstanding.)
- Licences issued:
- A count of applications licenced after completion of scientific review.
- Decisions:
- Points in the process where an action is recommended to license, reject, refuse, or request additional information, in regards to the application.
- First decision:
- Time from acceptance for review to either a licence being issued or a request for more additional information.
- Second decisions:
- Time from receiving a response to an additional information request to either issuing a license or making a subsequent additional information request.
Annual reports
- To request a full copy of the Medical Devices Directorate Annual Performance Report for April 1, 2025 - March 31, 2026, contact meddevices-instrumentsmed@hc-sc.gc.ca.
- To request a full copy of the Medical Devices Directorate Annual Performance Report for April 1, 2024 - March 31, 2025, contact meddevices-instrumentsmed@hc-sc.gc.ca.
For annual reports from 2013 – 2024, contact meddevices-instrumentsmed@hc-sc.gc.ca.
Quarterly reports
2025-2026
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2025-26, contact meddevices-instrumentsmed@hc-sc.gc.ca.
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2025-26, contact meddevices-instrumentsmed@hc-sc.gc.ca.
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2025-26, contact meddevices-instrumentsmed@hc-sc.gc.ca.
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2025-26, contact meddevices-instrumentsmed@hc-sc.gc.ca.
2024-2025
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2024–25, contact meddevices-instrumentsmed@hc-sc.gc.ca
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2024–25, contact meddevices-instrumentsmed@hc-sc.gc.ca
- To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2024–25, contact meddevices-instrumentsmed@hc-sc.gc.ca
- To request a full copy of Medical Devices Directorate Performance Quarterly Report for Q1 2024–25, contact meddevices-instrumentsmed@hc-sc.gc.ca
For quarterly reports from 2017-2023, contact meddevices-instrumentsmed@hc-sc.gc.ca.
Contact us
For more information about the reports, contact the Medical Devices Directorate.
Email: meddevices-instrumentsmed@hc-sc.gc.ca