Canada Emergency Use Pathways for Medical Devices and IVDs

Medical devices and in vitro diagnostic devices (IVDs) are regulated By Health Canada (HC), under the Canadian Medical Devices Regulations.

In response to the COVID-19 outbreak, HC has outlined an Interim Order (IO) for the importation and sale of medical devices for use in relation to COVID-19. HC has defined these medical devices as a: “COVID-19 medical device”: a medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)‍.

The IO was established in an effort to get unlicensed products into Canada that are approved in other jurisdictions.  The IO also allows HC to issue expanded indications for use to a device that either has been approved through this IO or a granted a medical device license.

The authorization is only valid as long as the IO is in effect. The IO will expire after 1 year, but may be renewed based on the ongoing public health need.

Regulations, guidance, and resources

This IO is based on and described further in the following legislation and guidance:

Device types and eligibility criteria

Devices that can take advantage of the IO must clearly indicate the role the device plays in the diagnosis, treatment, mitigation or prevention of COVID-19. Examples include:

  • Personal Protective Equipment (PPE) - generally Class I medical devices, including:
    • N95 face piece respirators,
    • gowns, masks, face shields,
    • isolation units, pods or rooms for transporting infected and contaminated patients,
    • nasal pharyngeal or oropharyngeal (OP) use only test swabs,
    • sample collection kits (not COVID-19 test kits).
  • UV Decontamination Devices (intended for decontaminating other medical devices) – Class II
  • Ventilators – Class III
  • COVID-19 test kits – Class III

HC has issued information regarding important regulatory considerations for these devices during the COVID-19 outbreak. HC is aware of and tracking increasing volumes of counterfeit products, products of substandard specifications, and those of inferior quality. Applicants are responsible for ensuring imported and sold products that meet the definition of a medical device are compliant with the Medical Devices Regulations.

Please refer to the following notices, device requirements, and information:

HC is also requesting medical device shortages are reported to HC to effectively and efficiently reporting to actual and anticipated medical device shortages.

Stay informed about special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. The situation is changing daily, and we encourage you to create a free RAMS account, where you can access real-time updates on COVID-19 regulatory developments from our international research team.

 

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Pathway Overview – COVID-19 Medical Devices

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 HC adds the requested products to the List, it will inform you of its decision.

To request to be added to the List, an establishment should:

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:


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


Summary of Important Contacts

Updated on 20 November 2020.

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