Importation and sale of medical devices for COVID-19 guidance document: Request a medical device be added to the list

Medical devices that are eligible for importation and sale under the interim order (IO) are known as “designated” devices. They are included in the list of medical devices for exceptional importation and sale. Health Canada maintains and updates this list as required.

There are 2 ways medical devices can be placed on the list:

1. an establishment may request to have a medical device added
2. Health Canada may add a device without receiving a proposal

An establishment that holds an active Medical Device Establishment Licence (MDEL) can ask Health Canada to add a medical device to the list. This is done by completing the medical devices for exceptional importation and sale request form.

Along with this proposal, the establishment should submit copies of the following for all of the devices listed in the request form:

• labels in English or French (for labelling requirements, please refer to sub-section 21(1) of the Regulations
• testing documents
• certification of the device

Email the completed application form and labels to Health Canada to:
medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca.

Reviewing IO applications

Health Canada considers a number of factors when reviewing the request for exceptional import and sale, such as:

• the product type
• availability of supply

Health Canada may contact the applicant for additional clarification or product-specific information. If we add the requested product(s) to the list, we will inform the applicant of this decision.