Pathway Overview – Summary
Medical devices permitted for exceptional importation and manufactured for sale under the IO may be imported into or manufactured for sale in Canada, provided they are on the List. There are two ways to be placed on the List:
- HC may add a medical device to the List without receiving a proposal.
- An establishment requests to have a medical device added to the List. If added, HC will inform the manufacturer.
To request to be added to the List, an establishment should:
- Complete and submit the HC Application Form for Exceptional Importation and Sale Form.
- The completed application form and French and/or English copies of the labels should be submitted electronically to HC at: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca
HC will assess the application and may contact the applicant for additional clarification or product specific information.
To import a device on the List, importers must:
- Notify HC, at least 5 calendar days before the day on which the device is imported, by completing the COVID-19 Medical Device Exceptional Importation and Sale Notification Form.
- Notifications should be sent to: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.
Pathway Overview – COVID-19 Class II-IV Medical Devices
Medical Devices that are Class II, III or IV follow the criteria in the Guidance:
- A MDSAP certificate is not required; manufacturers are required to share information to demonstrate that their products are of quality.
- Submit an IO application electronically to hc.devicelicensing-homologationinstruments.sc@canada.ca; include: (“COVID-19 Device Application” in the subject line).
- Include device details of safety and effectiveness information.
- Include an Attestation to the availability of documented procedures for certain activities: Distribution Records, Complaint Handling, Incident Reporting and Recalls.
- Note: If a foreign jurisdiction waives all pre-market submission and evaluation requirements, this would not be considered a foreign regulatory approval for the purposes of the IO.
- HC is waiving application fees for COVID-19 medical devices subject to the IO.
- Refer to the HC FAQs regarding importation requirements of medical devices approved under the IO.
Pathway Overview – COVID-19 Class I Medical Devices
Medical Devices or PPE that are Class I (not approved in Canada currently):
- Complete the MDEL application (FRM-0292); indicate in the subject line of the email: URGENT COVID-19 MDEL application for "- name of company"
- Email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca
Or
- Manufacturers of Class 1 medical devices may apply under the Interim Order (IO); in this instance an MDEL is not required
MDEL Holders who are or plan to manufacture, import or distribute non-compliant* Class I PPE’s:
- Complete the HC Personal Protective Equipment (PPE) - Notification form (download the form in Word)
- Provide a copy of the product label(s)
- Email the completed form along with a copy of the product label to hc.mdel.questions.leim.sc@canada.ca; include "COVID - Notification" in the subject line of the email to help HC fast-track requests
*Non-compliant = past expiry date, non-medical grade, may not have a bi-lingual label*
Additional Information
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016)
- Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic
- Notice for Hospitals: Mandatory Reporting Requirement during the COVID-19 Pandemic
- Special Access Program allows doctors to request access to medical devices not yet approved for sale in Canada and may be requested for emergency use; however, this is only allowed on a per patient basis.
- Public release of clinical information for drugs and medical devices in COVID-19 IO applications: Guidance
Medical Device Shortages
HC is requesting medical device shortages are reported to HC to effectively and efficiently reporting to actual and anticipated medical device shortages.
- Medical device shortages – Overview, List of Shortages, Report a Shortage
- Reporting medical device shortages – reporting form
Summary of Important Contacts
- Submitting proposals to add a medical device to the List: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca
- Submitting notifications of intended importations of designated medical devices: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca
- Submit an Authorization Form and/or Shortage Report: hc.meddev-matmed.sc@canada.ca
- Submit completed MDEL applications: hc.mdel.application.leim.sc@canada.ca
Updated on 12 March 2021.