Interim Order Keeps COVID‑19 Device Fast‑Track

Summary#

The Governor in Council approved Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The interim order, made by the Minister of Health on February 21, 2022, keeps in place an expedited pathway for authorizing COVID‑19 medical devices under the Food and Drugs Act, so those devices can continue to be imported and sold in Canada while the pandemic risk remains.

What it does#

• Keeps the emergency, faster authorization route that was used in 2020–2021 for COVID‑19 devices.
• Keeps three ways to authorize devices under the interim order:
  • an expedited authorization for new COVID‑19 devices;
  • allowing expanded uses for devices already authorized under the Medical Devices Regulations or earlier interim orders without a new application; and
  • accepting authorizations from certain trusted foreign regulators for new devices.
• Lets the Minister of Health decide how much evidence is needed for safety and effectiveness in light of urgent public health needs.
• Continues to allow devices already authorized under previous interim orders to remain on the market.
• Keeps post‑market rules: incident reporting, voluntary recall reporting, and record‑keeping for distribution. The Minister can add or change conditions on authorizations and can cancel them if needed.
• Requires importers and distributors of COVID‑19 devices to hold a medical device establishment licence.
• Maintains bilingual labelling requirements for manufacturers, importers and distributors.
• Manufacturers authorized under this interim order are not charged evaluation, amendment or “right‑to‑sell” fees.
• Without this Order in Council approval the interim order would have expired 14 days after it was made; with approval it will last until the earliest of repeal, new regulations coming into force, or one year after it was made (i.e. until February 21, 2023, unless changed sooner).

Who's affected#

• Device makers and importers who supply COVID‑19 products such as test kits, masks, respirators and other related devices.
• Distributors and health care organizations that buy or use those devices.
• Health care workers and Canadians who rely on timely access to tests, personal protective equipment and other COVID‑19 medical devices.
• If the source is unclear about a specific group, it would be manufacturers and importers whose products were previously authorized under the earlier interim orders.

(If you are unsure whether a specific device or company is covered, the interim order and Health Canada guidance are the authoritative sources.)

Why it matters#

• It keeps an emergency fast‑track in place so needed COVID‑19 devices can reach Canada more quickly than through normal regulatory timelines.
• That pathway has already been used extensively: over 770 authorizations, including 107 testing devices and over 660 other devices, which helped ease supply pressures during the pandemic.
• For health workers and patients, this reduces delays getting tools like rapid tests and N95 masks. For manufacturers and importers, it preserves a simpler, quicker route to sell COVID‑related devices in Canada while the government evaluates longer‑term regulatory options.