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. HC has proposed transition provisions for devices approved under the IO for long-term regulatory approval in Canada. Further information will be provided by HC later in 2021. Refer to the following notices for additional information:

• New Transition Regulations for the IO Respecting the Importation and Sale of Medical Devices (COVID-19): Notice to Stakeholders
• Ensuring Predictability for COVID-19 Clinical Trials and Proposal for Clinical Trials Records Retention: Notice to Stakeholders

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
• Classification Guidance for COVID-19 Medical Devices
• 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 of these types of devices and their risk classification follow: 

• Class I: masks, respirators, gowns, face shields/goggles, 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), thermal detection equipment used to detect elevated body temperature (not temperature)
• Class II: infrared thermometers, gloves, personal protective equipment (PPE) decontamination devices or sterilizers, examination gloves, syringes; probes and primers (analytic specific reagents (ASRs)
• Class III: ventilators
• Class IV: SARS-CoV-2 testing devices, quality controls, calibrators etc. that are intended to be used with a COVID-19 test kit

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
• 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.