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New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19): Notice to stakeholders On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the…

Medical Devices Compliance Program Bulletin - Canada.ca

Health CanadaCaptures 14Latest capture Apr 11, 2026en

Medical Devices Compliance Program Bulletin The Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch (ROEB) oversees the national compliance and enforcement program for medical devices. MDCP manages the risk posed to public health and…

List of regulatory agencies and foreign jurisdictions This list is incorporated into the Medical Devices Regulations . It sets out the regulatory agencies and foreign jurisdictions for the purposes of section 61.2 of the Regulations . The regulatory agencies and foreign…

Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada On this page Changes to the regulations Consultations and publication Coming into force Guidance documents Contact us Changes to the regulations Health Canada is…

Guidance on summary reports and issue-related analyses for medical devices: Overview Overview Summary reports Issue-related analyses of safety and effectiveness Download in PDF format (675 KB, 22 pages) Date published: 2026-04-09 On this page About the regulation of medical…

Incident reporting for medical devices: Guidance document Notice to Reader: This guidance clarifies the new amended Medical Device Regulations that deal with incident reporting, in effect as of June 23, 2021. See the guidance clarifying the Medical Devices Regulations that are…

Foreign risk notification for medical devices guidance document: Background Background Definitions Responsibilities and notifiable actions What, when and how to submit Monitoring, compliance and enforcement Download the alternative format (PDF format, 521 KB, 11 pages) Effective…

Publication of second Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users Date published: March 1, 2021 On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices…

Priority COVID-19 test applications: Notice to manufacturers, importers and distributors Notice to reader: For information on current priorities, please consult the following notice, Urgent Public Health Need Status for COVID-19 testing applications . Date published: May 7, 2021…

Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach On February 21, 2022, Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19 replaced Interim…

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