Medical device establishment licence changes

Summary#

The federal government (through Health Canada) is proposing the Regulations Amending the Medical Devices Regulations (Establishment Licences). If adopted, the changes would remove a duplicative licence requirement for many foreign sellers, require importers and distributors to give regular lists of their suppliers, and make certain safety procedures explicitly mandatory. This is a notice of proposed regulations published on November 8, 2025; stakeholders have 70 days to comment.

What it does#

• Removes the automatic rule that a Canadian importer with an establishment licence must import only from a foreign distributor who also holds an establishment licence under the Medical Devices Regulations (MDR). (Retailers and health care facilities that are not licensed would still have to buy from licensed suppliers.)
• Requires every establishment-licence applicant and holder to submit supplier information (name, address, and device class) when applying and to update it once a year at the annual licence review.
• Makes it explicit that manufacturers, importers and distributors must establish, implement and maintain documented procedures for safety-management activities such as:
  • maintaining distribution records;
  • incident reporting and serious-risk notifications;
  • handling, storage, delivery, installation, servicing and corrective actions (for Class II, III, IV where applicable).
• Removes some redundant application questions (e.g. medical specialties) and reduces some attestations in licence forms.
• Transitional and timing notes:
  • Applications already in progress would need to supply supplier lists before a licence is issued.
  • If these rules are adopted, they would come into force about six months after registration.

Who's affected#

• Canadian importers and domestic distributors that hold, or must apply for, a medical device establishment licence (about 2,300 organizations).
• Foreign distributors who sell into Canada (some may no longer need a Canadian licence if they sell only through a licensed Canadian importer).
• Manufacturers of Class I–IV devices to the extent they supply Canadian importers or need to meet the clarified procedure rules.
• Retailers and health care facilities that are not licence-holders — they still must buy from someone with an MDEL.
• Health Canada, which would receive and manage the supplier lists and change inspection/compliance practices.
• Small businesses: roughly 50% of current licence-holders who responded to past surveys identify as small; Health Canada estimates small firms would bear about half of estimated industry costs.

Why it matters#

• Less paperwork and duplication for many cross-border suppliers: removing the redundant foreign-licence requirement could make it easier and cheaper for some suppliers to sell into Canada and reduce barriers to market entry.
• Better traceability during safety problems: mandatory supplier lists give Health Canada a clearer line of sight on who sold what to whom. That should speed targeted inspections, recalls, and follow-up when devices cause harm or quality concerns.
• Clearer expectations on safety processes: making written procedures explicitly required reduces uncertainty about what firms must actually have in place (not just attest to). That can reduce gaps found during inspections.
• Costs and benefits (selected figures from Health Canada’s impact analysis):
  • Total monetized industry costs estimated at $1.8 million (present value) over 10 years.
  • Estimated benefit to foreign MDEL holders of $2.3 million (PV) over 10 years (not monetized for Canadian CBA purposes).
  • Health Canada expects an initial industry compliance cost of about $600,000 in the first year to compile supplier lists, and ongoing annual updates estimated at $184,000 in year 2 (and similar ongoing values).
  • Health Canada may collect about $333,000 less in fees per year from foreign distributors who would no longer need licences.
• This is a proposed regulatory change, not yet law. The proposal aims to align Canada more closely with other jurisdictions while trying to keep oversight needed to protect patient safety.