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Program directory · Health Canada

Medical Devices

Department
Health Canada
Program code
BVH03 (H)
Core responsibility
Health Protection and Promotion
In Departmental Plans
2018-19 – 2026-27 · New since an earlier plan

What it does

The Program is responsible for ensuring medical devices sold in Canada meet the safety, effectiveness, and quality requirements of the Medical Devices Regulations (the Regulations). It verifies that these regulatory requirements are met through pre-market application reviews, risk-benefit assessments, monitoring, surveillance, and compliance and enforcement activities. It also provides information to Canadians and health professionals to enable informed decision making about product use. Target stakeholders include industry (including market authorization holders and registered establishment license holders), health professionals and practitioners, and Canadians. Key stakeholder roles are to comply with responsibilities under the Food and Drugs Act and Regulations (industry); to promote the appropriate use of medical devices (health professionals and practitioners); and to report medical device incidents to Health Canada (industry; health care professionals/practitioners; hospitals; and Canadians).

Source: the department's Program Inventory, via GC InfoBase.

History and lineage

First appears in GC InfoBase's actual spending by program in 2018-19. The data does not record when a program was created; it may be older than its first appearance here, which is limited by the sources (program spending starts in 2010-11, Departmental Plans in 2018-19).

2018-192019-202020-212021-222022-232023-242024-252025-262026-272027-282028-29Medical Devices 2018-19: $18MMedical Devices 2019-20: $23.3MMedical Devices 2020-21: $23.7MMedical Devices 2021-22: $19.9MMedical Devices 2022-23: $27.6MMedical Devices 2023-24: $25.5MMedical Devices 2024-25: $21MMedical Devices 2025-26: $23MMedical Devices 2026-27: $22MMedical Devices 2027-28: $19.8MMedical Devices 2028-29: $17.9MMedical Devices
Bars: spending by fiscal year (dark: actual; light: actual restated on the 2017-18 program structure; outlined: the latest plan's forecast; grey: related programs). Bands: each program in the lineage over the years it has data.
ProgramRelationYears with dataActual spending over those years
Medical DevicesThis program2018-19 – 2028-29$159M

No earlier or later program in the same department has a similar name.

Significant changes in scope and budget

Detected from the data: renames between plans, programs it appears to replace, merge with or split into (matched by name), year-over-year changes in spending of at least 25% and $5M, or in employees of at least 20% and 25 FTEs, linked budget measures, and results indicators added or dropped.

YearWhat changedSource
2019-20Employees (FTEs) 352, against 283 in 2018-19 (+24%).FTEs (GC InfoBase)
2019-20Spending $23.3M, against $18M in 2018-19 (+30%).Actual spending (GC InfoBase)
2022-23Spending $27.6M, against $19.9M in 2021-22 (+39%).Actual spending (GC InfoBase)
2025-26Planned employees (FTEs) 271, against 382 in 2024-25 (−29%).FTEs (GC InfoBase)

Success criteria

The program's indicators from its department's Departmental Results Framework: the target set in each year's plan, and the result reported the following year. Source: GC InfoBase.

Historical: targets against results

Percentage of medical device applications (Class III and IV) that meet regulatory requirements
Expected result: Regulated parties are compliant with regulatory requirements
93%2018-19✓ met96%2019-20✓ met93%2020-21✓ met88%2021-22✗ not met96%2022-23✓ met95%2023-24✓ met95%2024-25✓ met

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2018-1990% – 100%201993%Met
2019-20≥ 90%202096%Met
2020-21≥ 90%202193%Met
2021-22≥ 90%202288%
Results were slightly lower than the target in 2021-2022. This could be because of updates to guidance documents related to technology advancements (e.g., digital health devices) that were not made as Health Canada’s focus was on COVID-19 medical device guidance documents.
Not met
2022-23≥ 90%202396%Met
2023-24≥ 90%202495%Met
2024-25≥ 90%202595%Met
Percentage of risk communications targeted to health professionals disseminated within service standards
Expected result: Partners, stakeholders and Canadians are informed of the risks and benefits of medical devices
100%2018-19✓ met50%2019-20✗ not met90%2020-21– no result75%2021-22✗ not met100%2022-23✓ met100%2023-24✓ met100%2024-25✓ met

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2018-1990% – 100%2019100%Met
2019-20≥ 90%202050%
Two out of four risk communications were disseminated within service standards. Given that the total number of risk communications is small, missing a service standard will have a disproportionate effect on overall performance.
Not met
2020-21≥ 90%2021—
The result is N/A as no risk communications were issued for medical devices this year.
No result reported
2021-22≥ 90%202275%
Target was not met as 3 out of 4 risk communications were disseminated within service standards. Given that the total number of risk communications is small, missing a service standard will have a disproportionate effect on overall performance.
Not met
2022-23≥ 90%2023100%Met
2023-24≥ 90%2024100%Met
2024-25≥ 90%2025100%Met

Current: the 2026-27 plan's targets

Percentage of medical device applications (Class III and IV) that meet regulatory requirements
Expected result: Regulated parties are compliant with regulatory requirements
90%2026-27

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2026-27≥ 90%2027—Planned
Percentage of risk communications targeted to health professionals disseminated within service standards
Expected result: Partners, stakeholders and Canadians are informed of the risks and benefits of medical devices
90%2026-27

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2026-27≥ 90%2027—Planned

Future goals: targets due after 2026-27

No targets with a later due date.

Spending and employees: planned against actual

Spending

2018-19: $21.9M2018-19: $18M2018-192019-20: $20M2019-20: $23.3M2019-202020-21: $23.1M2020-21: $23.7M2020-212021-22: $32.9M2021-22: $19.9M2021-222022-23: $22M2022-23: $27.6M2022-232023-24: $20.1M2023-24: $25.5M2023-242024-25: $20.4M2024-25: $21M2024-252025-26: $23M2025-262026-27: $22M2026-272027-28: $19.8M2027-282028-29: $17.9M2028-29
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-19$21.9M$18M
2019-20$20M$23.3M
2020-21$23.1M$23.7M
2021-22$32.9M$19.9M
2022-23$22M$27.6M
2023-24$20.1M$25.5M
2024-25$20.4M$21M
2025-26$23M—
2026-27$22M—
2027-28$19.8M*—
2028-29$17.9M*—

Employees (FTEs)

2018-19: 3562018-19: 2832018-192019-20: 3502019-20: 3522019-202020-21: 3672020-21: 3892020-212021-22: 4302021-22: 4592021-222022-23: 3192022-23: 4362022-232023-24: 2952023-24: 3992023-242024-25: 2712024-25: 3822024-252025-26: 2712025-262026-27: 2742026-272027-28: 2782027-282028-29: 2442028-29
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-19356283
2019-20350352
2020-21367389
2021-22430459
2022-23319436
2023-24295399
2024-25271382
2025-26271—
2026-27274—
2027-28278*—
2028-29244*—

Planned spending, plan by plan

Each row is one year's Departmental Plan and its forecast for the next three fiscal years; read a column down to see how the forecast for one year changed. The last row is what was actually spent. Click an amount for its source. Biggest changes in federal spending plans

Actual spending is from Departmental Results Reports and the Public Accounts, as published in GC InfoBase. FTEs are full-time equivalents.