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WTO notification · TBT

CanadaUpdated: check whether it is now adopted or in force

Medical equipment – Canada

Official title

Regulations Amending the Medical Devices Regulations (Establishment Licences) (30 pages, available in English and French)

Canada issued an addendum on 13 July 2026 to the earlier TBT notification G/TBT/N/CAN/758. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 13 November 2025. The comment period closed on 17 January 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

Updated here:

At a glance

Products

Medical equipment

Notifying member
Canada
Status
Updated: check whether it is now adopted or in force
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CAN/758Latest notice: G/TBT/N/CAN/758/Add.1
ICS classification
  • 11.040 Medical equipment

Key dates

Distributed by the WTO
Comment deadline
Closed on 17 January 2026
Proposed adoption
On the day these regulations are registered
Proposed entry into force
The proposed amendments to the MDR would come into force six months from the date of registration.

How to comment

The comment period closed on 17 January 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CAN/758/Add.1; it can take them up with Canada.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Latest notice (⁨G/TBT/N/CAN/758/Add.1⁩, 13 July 2026)

Regulations Amending the Medical Devices Regulations (Establishment Licences)

The WTO was notified of the proposed amendments to the MDR under G/TBT/N/CAN/758 on November 13, 2025. The objective of these amendments to the MDR is to modernize the Medical Device Establishment Licensing (MDEL) framework to better respond to a rapidly innovative industry, while maintaining oversight to better manage emerging health and safety risks. These objectives include reducing unnecessary burden to facilitate international alignment, improving Health Canada’s ability to identify and monitor non-compliant medical devices and establishments that may pose a risk of injury to health, and providing certainty with respect to the requirements in the MDR. Further, these amendments align with the objectives of the report on red tape reduction (RTR) and contribute to risk-based regulating. The amendments will remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. Having a licensed importer in Canada to manage risks to health and safety is sufficient for the traceability of devices when there are safety or quality issues. Persons without an MDEL that import (i.e. retailers and health care facilities) will continue to be required to verify that the foreign distributor whom they import from holds an MDEL. This amendment will more closely align Canada with other jurisdictions and reduce the redundancy in the current licensing scheme. The amendments to the MDR will require all MDEL applicants to provide supplier information as part of…

This proposal delivers on Phase II of Health Canada’s commitments set out in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enabling the oversight to better manage emerging health and safety risks. The proposed amendments would: remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. require all MDEL applicants to provide supplier information as part of their MDEL application and to update the supplier information once a year at annual licence review; Make explicit the requirement for manufacturers, importers and distributors to establish, implement and maintain all documented procedures relevant to their safety management activities. Most of the medical devices sold in Canada are imported, with a growing number of suppliers providing medical devices to the Canadian market. This, in addition to experimentation with regulatory flexibilities during the COVID-19 pandemic, demonstrates a need to update the current framework to allow Health Canada to continue to provide efficient, effective, and agile oversight of medical devices to protect the health and safety of people in Canada.

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/CAN/758/Add.1

    Regulations Amending the Medical Devices Regulations (Establishment Licences)

    The WTO was notified of the proposed amendments to the MDR under G/TBT/N/CAN/758 on November 13, 2025. The objective of these amendments to the MDR is to modernize the Medical Device Establishment Licensing (MDEL) framework to better respond to a rapidly innovative industry, while maintaining oversight to better manage emerging health and safety risks. These objectives include reducing unnecessary burden to facilitate international alignment, improving Health Canada’s ability to identify and monitor non-compliant medical devices and establishments that may pose a risk of injury to health, and providing certainty with respect to the requirements in the MDR. Further, these amendments align with the objectives of the report on red tape reduction (RTR) and contribute to risk-based regulating. The amendments will remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. Having a licensed importer in Canada to manage risks to health and safety is sufficient for the traceability of devices when there are safety or quality issues. Persons without an MDEL that import (i.e. retailers and health care facilities) will continue to be required to verify that the foreign distributor whom they import from holds an MDEL. This amendment will more closely align Canada with other jurisdictions and reduce the redundancy in the current licensing scheme. The amendments to the MDR will require all MDEL applicants to provide supplier information as part of…

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  2. Regular notificationG/TBT/N/CAN/758

    Comment deadline: Closed on 17 January 2026

    Regulations Amending the Medical Devices Regulations (Establishment Licences) (30 pages, available in English and French)

    This proposal delivers on Phase II of Health Canada’s commitments set out in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enabling the oversight to better manage emerging health and safety risks. The proposed amendments would: remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. require all MDEL applicants to provide supplier information as part of their MDEL application and to update the supplier information once a year at annual licence review; Make explicit the requirement for manufacturers, importers and distributors to establish, implement and maintain all documented procedures relevant to their safety management activities. Most of the medical devices sold in Canada are imported, with a growing number of suppliers providing medical devices to the Canadian market. This, in addition to experimentation with regulatory flexibilities during the COVID-19 pandemic, demonstrates a need to update the current framework to allow Health Canada to continue to provide efficient, effective, and agile oversight of medical devices to protect the health and safety of people in Canada.

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)Notified document (opens in a new tab)

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from Canada

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    Symbol: G/SPS/N/CAN/1654

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    Symbol: G/TBT/N/CAN/785Comments until 14 January 2027

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