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 is currently in effect until Fall of 2021, 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:

• Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19, and related guidance, Importation and sale of medical devices for COVID-19 guidance document: Background

• Expedited Access to COVID-19 diagnostic laboratory test kits and other medical devices

• Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19

• Guidance Document Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19

• Authorized Medical Devices for Uses Related to COVID-19

• Getting COVID-19 Medical Devices into Canada

• Explanatory Note: IO Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

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:

• Medical Gloves

• Medical Gowns

• 3D Printing and other manufacturing of PPE

• Optimizing the use of masks and respirators during the COVID-19 outbreak

• Non-medical masks and face coverings

• Technical requirements for UV decontamination devices: Notice to manufacturers

• Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order

• Regulatory considerations on the classification of non-medical masks or face coverings

• Testing devices for COVID-19 (nucleic acid, antigen, serological, point-of-care and self-testing; test swabs)

• Requirements for serological antibody tests submitted under the COVID-19 IO

  • Antigen testing devices: notice on minimum value for sensitivity

  • Serological testing devices: sensitivity and specificity values

  • Review Elements for Diagnostic Kits including noted deficiencies HC is finding in applications

• Buy and Sell Table – Listing of Product Specifications for Manufacturing Health Products

HC is also 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

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:

• 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 five 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)

• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

• 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

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 17 December 2020.