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Medical Device reports and publications - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 218408
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Medical device reports and publications - Canada.ca
Jan 2, 2026
hc-20260101
ID 429114
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updated2 sections changed; 9 added; 4 removed (high-noise change)
2 sections changed9 added4 removed+50 / -84 linesChange ratio: 77%
--- +++ @@ -1,104 +1,70 @@-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.+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.+On this page Reports and publications-This section contains links to reports and publications related to medical devices.+Medical devices performance reports+Contact us+Reports and publications+This section contains links to reports and publications related to medical devices, including: 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 2024-25, please contact+Good guidance practices+Summary Basis of Decision documents+Regulatory Decisions Summaries+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+2024-2025+To request a full copy of the Medical Devices Directorate Annual Performance Report for April 1, 2024 - March 31, 2025, contact publications@hc-sc.gc.ca .-To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2024-25, please contact+For annual reports from 2013 to 2024, contact publications@hc-sc.gc.ca .-To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2024-25, please contact+Quarterly reports+2025-2026+To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2025–26, contact, contact publications@hc-sc.gc.ca .-To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2023-24, please contact+2024-2025+To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q4 2024–25, contact publications@hc-sc.gc.ca .-To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2023-24, please contact+To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q3 2024–25, 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+To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q2 2024–25, 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+To request a full copy of the Medical Devices Directorate Performance Quarterly Report for Q1 2024–25, 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+For quarterly reports from 2017 to 2023, 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, 2023 - March 31, 2024 please contact-publications@hc-sc.gc.ca-.-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 (+Contact us+For more information about the reports, contact the Medical Devices Directorate.+Email: meddevices-instrumentsmed@hc-sc.gc.ca-). Page details-Date modified:-2025-01-24+2025-09-12