Medical device establishment licensing changes

Summary#

On November 8, 2025, Health Canada published a proposal called the Regulations Amending the Medical Devices Regulations (Establishment Licences). If adopted, it would remove a duplicated licence requirement for some foreign distributors, require licensed importers/distributors to give a list of their suppliers, and make certain safety-management procedures explicitly required. This is a proposal open for comment — it is not law yet.

What it does#

• Removes the rule that forced foreign distributors to hold an establishment licence when they sell to a Canadian importer who already has one. Retailers and health-care facilities that do not hold a licence would still have to buy from suppliers who do.
• Requires every establishment licence (MDEL) applicant and holder to provide supplier information (name, address, and device class) with their application and to update it once a year at licence review.
• Makes it explicit that manufacturers, importers and distributors must establish, implement and maintain documented procedures for key safety activities such as:
  • keeping distribution records,
  • incident reporting and providing information about serious risks,
  • handling, storage, delivery, installation, servicing and corrective actions (as applicable),
  • complaint handling and recalls (already required in practice).
• Removes some existing attestation paperwork and one data field (medical specialties) that Health Canada says is not useful.
• Would take effect 180 days after the regulations are registered (about six months). Applications already in process at that time would need to submit supplier information before a licence is issued.

Who's affected#

• Canadian importers and distributors: most will need to submit supplier lists at application and annually. Health Canada estimates about 2,300 importers/distributors in scope, with roughly 1,500 not currently providing supplier lists who would need to do so in year one.
• Foreign distributors: some that sell only through licensed Canadian importers would no longer need a Canadian establishment licence. Others (those selling directly to retailers or health-care facilities) would still need one.
• Manufacturers (especially Class II–IV): already subject to quality system rules, but the changes make some expectations clearer.
• Health Canada: would collect and manage the new supplier data and update guidance; estimated internal cost over 10 years $163,000 (PV).
• Small businesses: about half of current MDEL holders reported being small businesses; Health Canada says the changes are intended to lower burden and increase supplier options, though there will be modest reporting costs.
• The public and health systems: indirectly affected because the changes aim to improve traceability and oversight when problems arise.

Why it matters#

• It aims to reduce a licensing duplication that industry said made Canada less aligned with other markets and could discourage suppliers from selling here. That could help keep more medical devices available.
• Mandatory supplier lists give Health Canada better ability to trace where a device came from if safety problems occur. That should speed recalls and targeted inspections.
• Making procedural requirements explicit should reduce confusion about what importers and distributors must do to manage safety risks once devices are on the market.
• There are modest costs and savings: Health Canada estimates total industry reporting costs of about $1.68M (PV) over 10 years and total monetized costs of $1.8 million (PV); it also estimates benefits to some foreign licence holders of about $2.3 million (PV) (not counted in Canadian cost–benefit totals). First-year industry reporting cost is about $600,000.
• This is a proposed regulatory change. Interested parties had 70 days from publication to comment, and the measures would only take effect if the regulations are finalized and registered.