Medical Devices

Current Consultations

• Consultation: Notice of intent to amend the regulations to address health product shortages in Canada [2024-06-25]
• Share your views: Consultation on draft guidance for determining medical device application type [2023-09-11]
• Share your views: Draft Pre-market guidance for machine learning-enabled medical devices [2023-08-30]
• Consultation on improving access to drugs and other health products in Canada [2023-06-05]
• Consultation on the Issue identification paper: Drug-device combination products draft [2021-05-10]
• Consultation on Draft Guidance Document: Software as a Medical Device (SaMD) [2019-01-29]
• Consultation on Draft Guidance Document - Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
• Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices [2018-04-16]
• Consultations on improving the regulatory review of drugs and devices
• Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada [2018-04-10]
• Consultation on fee proposal for drugs and medical devices [2017-10-11]

Past Consultations

• Consultation: Proposed Changes to the Medical Devices Directorate's List of Recognized Standards for Medical Devices [2022-06-24]
• Consultation on the Draft Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing [2017-07-31]
• Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices [2016-09-14]
• Consultation Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices [2016-09-14]
• Consultation on five Medical Device Forms [2015-07-24]

Additional Resources

• Acts & Regulations
• Association Meetings
• Scientific/Expert Advisory Committees
• Scientific/Expert Advisory Panels