Disclaimer: Information and external links provided on this page are intended for Health Care Professionals for informational and reference purposes only and are provided as general regulatory resources. Nothing on this page is intended to advertise, promote, or solicit the sale of any medical device that is not licensed for sale in Canada.
Health Canada – License Holder Listings
- Health Canada (MDEL Licences): Medical devices establishment license listing
- Health Canada (MDALL Licences): Medical devices active licenses search
- Health Canada (Site Licences): Site Licence Holders List
- Health Canada (NPN): Licensed Natural Health Products
- Health Canada (DIN): Drug Product Database
Health Canada – Recalls & Safety Alerts
Access current Health Canada recalls, advisories, and safety alerts related to medical devices and other health products.
- Health Canada: Recalls & Safety Alerts
- Health Canada: Subscribe for Medical Device Updates
Health Canada – Medical Device Problem Reporting
Health Canada provides reporting pathways for hospitals, health care professionals, consumers, and industry to report medical device problems and incidents.
For medical devices distributed by Martket, please also report any product complaints or incidents to complaints@martkethealth.com so that we can investigate and address them in accordance with our regulatory obligations.
- Health Canada: Report a Medical Device Problem or Incident
- Health Canada: Mandatory Reporting Requirements for Hospitals
Health Canada – Special Access Program
Health Care Professionals are responsible for initiating a Special Access application for situations where unlicensed medical devices are required for emergency situations, or when conventional therapies have failed, are unavailable or are unsuitable.
- Health Canada: Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices
- Health Canada: Request access to a medical device through the Special Access Program
- Health Canada: Instructions for Completing the Application Form for Custom-Made Devices and Medical Devices for Special Access
- Health Canada: Application Form for Custom-Made Devices and Medical Devices for Special Access
Health Canada – Submitting a Special Access Application:
Medical Devices Special Access Programme
Business Hours 8:00am – 4:30pm ET
Email (preferred): sap.devices.mdb@hc-sc.gc.ca
Telephone: 613-946-8711
24-Hour Emergency Request (outside normal business hours): 613-410-9186
Fax: 613-957-1596
Foreign Risk Notification & Monitoring
Martket regularly monitors Foreign Risk Notifications (FRNs), including recalls and safety alerts issued by regulatory agencies in other countries. This includes all countries participating in the Medical Device Single Audit Program (MDSAP), as well as the countries where medical devices imported by Martket are manufactured:
- Australia – Alerts | Recalls
- Brazil – Alerts | Recalls
- Canada – Alerts | Recalls
- Germany – Alerts | Recalls
- Israel – Alerts | Recalls
- Japan – Alerts | Recalls
- Spain – Alerts | Recalls
- USA – Alerts | Recalls
In addition to monitoring other regulatory agencies, Martket also reviews device safety information published through the International Medical Device Regulators Forum’s (IMDRF) National Competent Authority Report (NCAR) program: