COVID-19 Medical Device Interim Order

Summary#

This Canada Gazette notice includes several government actions published on March 28, 2020, most notably an emergency rule from Health Canada that speeds up the import and sale of medical devices for use with COVID‑19. It also lists a set of fee increases (about 2%) taking effect April 1, 2020, a crude‑oil‑by‑rail levy, a short Bank of Canada financial statement, and a brief Bank of Canada policy notice.

What it does#

• Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (made March 18, 2020)

  • Creates an expedited pathway so certain COVID‑19 devices (tests, protective equipment, ventilators, etc.) can be imported and sold in Canada more quickly than under the usual rules when the Minister finds there is an urgent public‑health need.
  • Requires a manufacturer to file an application with specific information. The Minister can use foreign authorizations as evidence and may impose terms or cancel authorizations.
  • Sets basic labelling rules and requires each imported shipment to include a copy of the authorization.
  • Requires the authorization holder to report any device incident in Canada within 10 days of becoming aware of it.
  • Allows Health Canada to broaden the listed uses of some devices during the pandemic and to waive normal fees for devices authorized under this Order.

• Fee increases (all adjusted by about 2.0%, effective April 1, 2020)

  • Cannabis Fees Order: screening fees for licence applications, e.g. micro‑cultivation screening rises from $1,675 to $1,709; standard cultivation from $3,350 to $3,417; other related fees such as security clearance and import/export permits are also adjusted.
  • Health Products & Food Branch fees:
    • Certificate of Pharmaceutical Product: $90 → $92.
    • New master file registration: $1,248 → $1,273.
    • Drug Master File letter of access: $176 → $180.
    • Drug Master File update: $541 → $552.
  • Dealer’s licences:
    • Dealer’s Licence (human drugs): $5,288 → $5,394.
    • Dealer’s Licence (veterinary drugs): $1,788.50 → $1,824.27.
  • Certificate of Supplementary Protection fee: $9,376 → $9,564.

• Transport

  • Levy on shipments of crude oil by rail set at $1.79 per tonne for the year beginning April 1, 2020.

• Bank of Canada notices

  • Short notice that an amendment to the Bank of Canada’s policy for buying and selling securities was published as an extra volume on March 18, 2020 (no detail in this notice).
  • Statement of financial position as at February 29, 2020, showing total assets of $122,855.7 million and bank notes in circulation of $89,146.8 million.

Who's affected#

• Manufacturers, importers and sellers of medical devices and diagnostic tests linked to COVID‑19. Health‑care providers and labs will notice faster access to some devices.
• Businesses and applicants in the legal cannabis sector (licence applicants and holders).
• Pharmaceutical companies that use Drug Master Files, and firms that need Certificates of Pharmaceutical Product.
• Holders of dealer’s licences for human and veterinary drugs.
• Companies shipping crude oil by rail (they pay the levy; costs could be passed on).
• Financial and market watchers who follow the Bank of Canada’s finances and policy notices.

If any of the items are unclear about who is affected, the Gazette text notes the same uncertainty.

Why it matters#

• The health‑device interim order aims to speed access to tests, personal protective equipment, ventilators and other devices during the COVID‑19 emergency. That can help hospitals and labs move faster to diagnose and treat patients. At the same time, the rule allows more flexibility on the level of evidence required, and so it keeps safety monitoring (like incident reports) in place.
• The fee increases are small (about 2%) but affect the cost of licence applications and regulatory services for businesses in healthcare, cannabis, and pharmaceuticals.
• The crude‑oil‑by‑rail levy is a specific per‑tonne charge that shippers must plan for over the year beginning April 1, 2020.
• The Bank of Canada figures give a snapshot of the central bank’s balance sheet just before March 2020 month‑end. The separate policy amendment notice signals the Bank was updating how it handles securities operations at that time, though details were published elsewhere.