Medical Device reports and publications

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Reports and publications

This section contains links to reports and publications related to medical devices.

• Announcements
• Application Information - Reports
• Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.
• The Safety of Dental Amalgam [2002-08-12]

Medical Devices Performance Reports

The Medical Devices Performance Reports provide detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards. The report compares five quarters, and the report is broken down by Parts of the Regulations and the applications types covered by them. Within the report, statistics are provided by submission type and show the number received, the number licensed the number in workload, the number of decisions and time to first decision against Cost Recovery service standards.

Applications Received are counts of submissions received during the Quarter using the filing date (AC date) which is the date the submission is considered received by Health Canada. Workload is the number of submissions "in process" on a given day. Backlog is the proportion of the workload that is over target Often the term workload is used to mean the amount of work received over a period of time and is a common source of confusion. Licences issued are a count of applications licenced after completion of scientific review. Decisions are points in the process where an action is recommended to license, reject, refuse, or request additional information, in regards to the application. First decision is measured from acceptance for review to the issuance of a licence or a request for further information (AI). Second decisions are measured from receipt of a response to an AI to a decision to license or issuance of a subsequent AI.

Quarterly Reports:

• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2023-24, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2023-24, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2023-24, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2022-23, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2022-23, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2022-23, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2022-23, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2021-22, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2021-22, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2021-22, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2021-22, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2020-21, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2020-21, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2020-21, please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2020-21, please contact publications@hc-sc.gc.ca.
• You can also contact us at: publications@hc-sc.gc.ca for 2017–2020 quarterly reports.

Annual Reports:

• To obtain a full electronic copy of the Medical Devices Directorate Annual Performance Report for April 1, 2022 - March 31, 2023 please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Annual Performance Report for April 1, 2021 - March 31, 2022 please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Annual Performance Report for April 1, 2020 - March 31, 2021 please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Directorate Annual Performance Report for April 1, 2019 - March 31, 2020 please contact publications@hc-sc.gc.ca.
• To obtain a full electronic copy of the Medical Devices Bureau Annual Performance Report for April 1, 2018 - March 31, 2019 please contact publications@hc-sc.gc.ca.
• You can also contact us at: publications@hc-sc.gc.ca for 2013 – 2017 annual reports.

For more information regarding the reports please contact Medical Devices Directorate (meddevices-instrumentsmed@hc-sc.gc.ca).