Canada Emergency Use Pathways for Medical Devices and IVDs

Medical devices and IVDs (medical devices) 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 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. COVID-19 related medical devices which are permitted for exceptional importation and manufactured for sale under the IO are identified in the List of Medical Devices for Exceptional Importation and Sale (List).

The IO also makes it mandatory for manufacturers and importers to report shortages of specified medical devices (or their components, accessories, parts or consumable materials), related to COVID-19, to HC. Shortages that must be reported do not include cases where there is a substitute device, component, accessory or part available. The requirements are outlined in the IO while the medical devices that are subject to mandatory reporting requirements are set out in the List of Medical Devices – Notification of Shortages.

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
• 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
• List of medical devices for exceptional importation and sale
• List of medical devices for expanded use in related to the COVID-19 pandemic
• List of diagnostic devices for use against coronavirus (COVID-19)   
• Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order
• 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 swabs.
• Ventilators – Class III
• COVID-19 test kits – Class III
  
  • NOTE: Due to the significant risk of improper usage or misinterpretation of result, HC issued a notice stating that it will not be authorizing home test (self-testing) kits for COVID-19. HC reiterates that only COVID-19 tests used by healthcare professionals or trained operators may be authorized under the IO for importing and selling medical devices.

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 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
• Regulatory considerations on the classification of non-medical masks or face coverings
• Requirements for serological antibody tests submitted under the COVID-19 IO
• 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
• Refer to HC’s MDEL Bulletin for additional information and reporting requirements

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.