Medical device announcements
Current (2026)
- Updates to the forms for exceptional importation and sale for medical devices [2026-09-02]
- New changes to the application process for the Special Access Program for medical devices: Notice [2026-08-24]
- Consultation: Proposed changes to the List of recognized standards for medical devices [2026-07-27]
- Expectations for information submitted with Class III and IV medical device licence applications: Notice to industry [2026-07-16]
- Phase 2 of our work to modernize medical device establishment licensing [2026-06-17]
- Guidance on the regulatory enrolment process for medical devices [2026-04-24]
- Mandatory use of the regulatory enrolment process for medical devices [2026-04-24]
- Guidance on how to complete the application for a new medical device licence or amendment for a private label medical device [2026-04-24]
- Guidance on how to complete the application for a new or amended medical device licence [2026-04-24]
- Guidance on how to interpret "significant change" of a medical device [2026-03-31]
- Change in classification of COVID-19 testing devices: Notice to industry [2026-03-18]
- Device licence applications for diagnostic ultrasound systems and transducers: Notice to industry [2026-01-19]
Previous (2025-2006)
2025
- Health Canada IMDRF table of contents for medical device applications guidance [2025-11-25]
- Guidance on managing applications for medical device licences [2025-11-21]
- Guidance for determining medical device application type [2025-08-29]
- The eSTAR pilot: Notice to industry [2025-08-19]
- Medical masks and respirators: Information for manufacturers (Updated) [2025-06-26]
- Share your views: Consultation on draft guidance on co-packaged drug products [2025-03-18]
- Share your views: Consultation on the draft guidance on managing applications for medical device licences [2025-02-20]
- Biotin and the risk of false lab test results [2025-01-10]
2024
- Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada [2024-12-30]
- Guidance on terms and conditions for class II to IV medical devices [2024-12-18]
- Updated: Regulatory enrolment process [2024-12-11]
- Nasal rinsing devices and the risk of infection [2024-09-11]
- Medical device safety [2024-07-31]
- Updated: Regulatory enrolment process (REP) [2024-07-31]
- Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices [2024-07-25]
- Share your views: Updates made to list of recognized standards for medical devices and draft guidance [2024-07-25]
- Building resilience: Health Canada's plan to address health product shortages, 2024 to 2028 [2024-06-25]
- Transparency for machine learning-enabled medical devices: Guiding principles [2024-06-13]
- Memorandum of Understanding between the Competition Bureau and Health Canada [2024-03-07]
- Share your views: Draft guidance on how to interpret 'significant change' of a medical device [2024-02-07]
- Amendments to the Medical Devices Regulations to address future public health emergencies [2024-01-03]
2023
- Updates to the medical device establishment licence application (FRM-0292) and instructions [2023-12-04]
- Predetermined change control plans for machine learning-enabled medical devices: Guiding principles [2023-10-24]
- Share your views: Consultation on draft guidance for determining medical device application type [2023-09-11]
- Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) [2023-08-30]
- Share your views: Draft Pre-market guidance for machine learning-enabled medical devices [2023-08-30]
- Potential risk of falls from infant incubators and radiant warmers [2023-07-13]
- Patient lifts and risk of fall [2023-06-14]
- Serious adverse drug reactions and medical device incidents reported by Canadian hospitals [2023-03-23]
- Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies [2023-03-23]
- Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice [2023-03-23]
- Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices [2023-03-06]
- Tubed medical devices and children [2023-01-27]
- Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10]
2022
- Pulse oximeters [2022-12-30]
- Consultation on proposed agile regulations and guidance for licensing drugs and medical devices [2022-12-16]
- Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21]
- List of Recognized Standards for Medical Devices [2022-11-15]
- Medical devices contained in electronic health record (EHR) products: Notice to industry [2022-10-31]
- Mpox (monkeypox) tests: Notice to industry [2022-10-19]
- Proposed changes to the Medical Devices Directorate's draft list of recognized standards for medical devices [2022-06-24]
- Insulin product and pump compatibility claims: Regulatory notice [2022-06-06]
- Subscribe to breast implant updates [2022-04-06]
- Breast Implants - Summary Safety Review [2022-04-06]
- Monthly Update to the List of New Safety and Effectiveness Reviews [2022-04-06]
- Classification of products for moxibustion: Notice to stakeholders [2022-03-14]
- New CSA Group standard for filtering respirators: Notice [2022-01-10]
2020
- Update: Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-03-20]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-03-05]
- Notice: Implementation of eCTD for Clinical Trial Regulatory Activities [2020-02-19]
2019
- Notice: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification [2019-12-18]
- Notice: Update: Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about changes to medical device treatment options [2019-12-13]
- Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences [2019-05-30]
- Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada [2019-03-19]
- Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format [2019-02-28]
- Important Information to Stakeholders - Implementation of Advance Notice of Importation Process for Medical Devices [2019-02-12]
2018
- Consultation on Draft Guidance Document - Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
- Notice - Guidance Document: Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations [2018-11-21]
- Notice: Classification of Medical Devices used to Deliver Drugs by Smoking [2018-10-11]
- Notice - Device Advice: Health Canada launching a new pilot project to formalize a framework aimed at offering regulatory advice to medical device manufacturers [2018-09-05]
- Notice: Upcoming Guidance Development on the Licensing Requirements for 3D-Printed Devices [2018-08-29]
- Notice - Health Canada's Intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications [2018-08-21]
- Notice: Medical Device Cybersecurity [2018-08-15]
- Notice: Changes to Evidence in Requirements for Class II and Class III Infusions Pumps [2018-08-13]
- Notice: Improving access to medical devices information [2018-05-22]
- Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices [2018-04-16]
- Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada [2018-04-10]
2017
- Notice: Publication of the Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing [2017-11-20]
- Notice: Regarding the Disclosure of Information on Medical Device Licence Applications Submitted to Health Canada [2017-03-31]
- Notice: GD207: Guidance on the Content of the ISO 13485 Quality Management System Certificates issued by Health Canada recognized registrars [2017-03-14]
2016
- Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices [2016-09-14]
- Medical batteries [2016-08-05]
- Notice: Decorative contact lenses [2016-06-10]
- Update: Notice to Stakeholders - Health Canada's Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use [2016-05-04]
- Notice: Medical Gloves [2016-04-04]
- Notice: Risk of thermal harm from therapeutic medical lasers, intense pulsed light and light emitting diodes [2016-02-08]
2015
- Notice: Health Canada Requirements for Manufacturers Relating to Manufacturing Change to Tyvek®1073B and 1059B [2015-11-03]
- Notice: Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices, and the Release of related Final Guidance Documents and Application Forms [2015-07-09]
2014
2013
2011
2010
2006
COVID-19
June 2024
- Medical masks and respirators [2024-06-12]
February 2023
- Medical devices for use in relation to COVID-19 [2023-02-22]
- Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice [2023-02-22]
- List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 [2023-02-22]
October 2022
- Updated Consultation on amendments to regulations to import and sell COVID-19 medical devices [2022-10-25]
- Updated policy position COVID-19 rapid antigen self-testing devices used for serial testing: Notice to industry [2022-10-14]
September 2022
- Urgent public health need status for COVID-19 testing applications: Notice to industry [2022-09-26]
- Subscribe to medical device updates [2022-09-16]
April 2022
- Keeping Health Products In Canada Safe [2022-04-05]
March 2022
- Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
- Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations [2022-03-02]
- Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulations [2022-03-02]
February 2022
- Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages [2022-02-22]
- Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19: Notice [2022-02-21]
- Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022 [2022-02-16]
September 2021
- Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice [2021-09-01]
August 2021
- Industry Advisory Roundtable on COVID-19 testing: Taking stock and looking forward [2021-08-13]
- Priority strategies to optimize self-testing in Canada: Expert Advisory Panel report [2021-08-12]
- Notice to industry: Regulatory requirements for UV light-emitting products with COVID-19 claims [2021-08-05]
July 2021
- Medical devices no longer considered to have urgent public health need status: Notice to industry [2021-07-16]
- COVID-19 rapid antigen testing devices that use serial testing for asymptomatic individuals: Notice to industry [2021-07-09]
June 2021
- Industry Advisory Roundtable on COVID-19 testing: Border measures [2021-06-18]
- Interim order regulating certain UV radiation-emitting and ozone-generating devices under Pest Control Products Act: Notice [2021-06-07]
May 2021
- Medical Devices Action Plan: Progress report [2021-05-28]
- Priority strategies to optimize testing and quarantine at Canada's borders: Testing Expert Advisory Panel report [2021-05-27]
- Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03]
- Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents [2021-05-03]
April 2021
March 2021
- Industry Advisory Roundtable on COVID-19 testing: Task Shifting and Self-Administration for Workplace Screening Programs [2021-03-26]
- Health Canada responds quickly to potential medical device shortages during COVID-19 [2021-03-26]
- What was heard: Consultation on interim order transition for tools to address drug and medical device shortages [2021-03-17]
- Priority strategies to optimize testing and screening for primary and secondary schools [2021-03-12]
- Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
- Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users [2021-03-01]
February 2021
- Priority strategies to optimize testing and screening in long-term care homes [2021-02-26]
- Notice to manufacturers, importers and distributors: Research use only for COVID-19 tests [2021-02-19]
- Industry Advisory Roundtable on COVID-19 report: Accelerating Rapid Screening in the Workplace [2021-02-18]
- COVID-19 Medical Device Establishment Licence (MDEL) suspensions [2021-02-11]
January 2021
- Regulatory innovation for health products [2021-01-29]
- Non-contact infrared thermometers (NCIT) [2021-01-28]
- Ensuring predictability for exceptionally imported health products: Notice to industry [2021-01-22]
- Join a WebEx tutorial on the 2021 annual licence review (ALR) application process [2021-01-22]
- Notice: Consultation on Proposed Changes to the Medical Devices Directorate's Draft Guidance Document - List of Recognized Standards for Medical Devices [20201-01-15]
- Priority strategies to optimize testing and screening for COVID-19 in Canada: Report [2021-01-15]
- COVID-19 Testing and Screening Expert Advisory Panel: Reports and summaries [2021-01-15]
December 2020
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
- Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders [2020-12-10]
- Importation and sale of medical devices for COVID-19 guidance document [2020-12-01]
- COVID-19 antibody (serology) testing: Information for patients [2020-12-01]
November 2020
- Industry Advisory Roundtable on COVID-19 Testing, Screening, Tracing and Data Management [2020-11-26]
- Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders [2020-11-23]
- Expert outreach and collaboration on COVID-19 testing and screening [2020-11-17]
- Testing and Screening Expert Advisory Panel [2020-11-17]
- Technical requirements for UV decontamination devices: Notice to manufacturers [2020-11-06]
October 2020
- Regulatory considerations on the classification of respirators [2020-10-20]
- Health Canada's special access programs [2020-10-14]
- Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance [2020-10-07]
- Pan-Canadian COVID-19 Testing and Screening Guidance [2020-10-07]
September 2020
- Testing devices for COVID-19: Antigen testing devices [2020-09-29]
- COVID-19 guidance for reporting medical device shortages [2020-09-28]
August 2020
- Testing devices for COVID-19: test swabs safety and effectiveness [2020-08-26]
- Regulatory considerations for the importation or sale of face shields [2020-08-26]
- Safety and performance specifications for respirators during COVID-19: Guidance for Canadian manufacturers [2020-08-25]
July 2020
- Regulatory considerations on the classification of non-medical masks or face coverings [2020-07-24]
- Health Canada's regulatory response to COVID-19: Access to health products [2020-07-03]
June 2020
- COVID-19 serological testing devices: Notice on sensitivity and specificity values [2020-06-24]
- Testing devices for COVID-19: Home testing devices [2020-06-19]
- Medical devices for uses related to COVID-19 [2020-06-05]
May 2020
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2020-05-27]
- Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents [2020-05-27]
- Applications for medical device clinical trials under the Interim Order: Guidance document [2020-05-07]
- Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19 [2020-05-05]
April 2020
- Engaging with international partners on COVID-19 [2020-04-30]
- International Coalition of Medicines Regulatory Authorities (ICMRA) statement on COVID-19 [2020-04-29]
- Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance [2020-04-23]
- Ventilators for patients with COVID-19 [2020-04-17]
- Reprocessing of N95 Respirators for Healthcare Professionals - Notice [2020-04-16]
- Health Product Advertising Incidents related to COVID-19 [2020-04-16]
- Notice - Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response [2020-04-08]
- Council of Chief Medical Officers of Health Communication: Use of Non-Medical Masks (or Facial Coverings) by the Public [2020-04-07]
- Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2020-04-05]
- Medical device shortages [2020-04-05]
- Exceptional importation and sale of medical devices against COVID-19 [2020-04-05]
- Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak - Guidance to industry [2020-04-03]
- Personal protective equipment against COVID-19 [2020-04-02]
- Important regulatory considerations for the supply of medical gowns - Guidance to Industry [2020-04-02]
- COVID-19 health product industry [2020-04-01]
March 2020
- 3D printing and other unconventional manufacturing of personal protective equipment in response to COVID-19 [2020-03-31]
- Considerations in the use of homemade masks to protect against COVID-19 [2020-03-26]
- List of diagnostic devices for use against coronavirus (COVID-19) [2020-03-26]
- Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document [2020-03-26]
- Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order [2020-03-25]
- Optimizing the use of masks and respirators during the COVID-19 outbreak [2020-03-24]
- Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 [2020-03-18]