Health Canada Updates Medical Device Shortage and Discontinuation Reporting Guidance
Health Canada has issued Version 4 of its Guide to reporting and providing information on medical device shortages and discontinuations (GUI-0137).
The updated guidance was issued on 7 October 2026 and will come into effect on 17 June 2027. Until that date, regulated parties should continue using the current version. 1791526992843
The new version replaces Version 3, dated 2 March 2022. 1791526992843
Why the Guidance Was Updated
The document change log shows that several provisions of the Canadian Medical Devices Regulations (MDR) were added or amended in 2026.
According to Health Canada:
sections 62.221, 62.241 and 62.242 were added;
sections 62.21, 62.22, 62.23, 62.24, 62.25 and 62.26 were amended;
paragraph 62.23(1)(i) was repealed. 1791526992843
The updated guide is intended to help regulated parties understand and comply with the revised framework.
Why Shortage Reporting Matters
Health Canada explains that mandatory reporting of medical device shortages and discontinuations is intended to improve transparency and reduce the risk of supply disruption.
The reporting framework helps to:
make information on shortages and discontinuations publicly available;
prepare healthcare systems and supply chains for possible gaps in supply;
support strategies to prevent or mitigate the impact of shortages or discontinuations on health. 1791526992843
Who the Guidance Applies To
GUI-0137 is intended to help:
manufacturers of Class I to IV medical devices;
importers of Class I devices;
comply with sections 62.21 to 62.25 of the MDR. 1791526992843
These provisions concern the reporting of shortages and discontinuations of certain categories of medical devices, including:
components;
accessories;
parts. 1791526992843
The guidance also applies to manufacturers, importers and distributors in relation to information requests under section 62.26. 1791526992843
Ministerial Requests for Shortage Information
The Medical Devices Regulations also give the Minister authority to request information relating to a medical device shortage or a device that is at risk of shortage.
The guidance explains that this requirement may apply to:
manufacturers;
importers;
distributors
where they hold the relevant information under their control. 1791526992843
This strengthens the regulator’s ability to obtain timely supply-chain information when shortage risks arise.
Specified Medical Devices
Mandatory shortage and discontinuation reporting applies to categories of devices included on the List of Medical Devices – Shortages and Discontinuation of Sale.
This is also referred to as the List of Specified Medical Devices. 1791526992843
A medical device belonging to a category on that list is considered a specified medical device for the purposes of the reporting requirements.
List Incorporated by Reference
The List of Specified Medical Devices is incorporated by reference into the Medical Devices Regulations.
Health Canada notes that the list may be updated from time to time in accordance with its incorporation-by-reference policy. 1791526992843
This means manufacturers and importers should monitor the list regularly rather than relying on a static version.
Voluntary Reporting for Other Devices
The guidance also provides information on how to voluntarily report shortages or discontinuations for devices that are not included on the specified list. 1791526992843
This can help Health Canada identify emerging supply concerns even where mandatory reporting does not apply.
Scope of the Ministerial Information Requirement
The requirement relating to the Minister’s power to request shortage information applies to manufacturers, importers and distributors that hold:
a medical device licence; or
a medical device establishment licence. 1791526992843
This means the obligations can extend beyond the manufacturer to other economic operators in the Canadian supply chain.
Guidance Is Administrative, Not Legislation
Health Canada emphasises that GUI-0137 is an administrative guidance document and does not itself constitute legislation.
Where there is any inconsistency between the guidance and applicable legislation, the legislation takes precedence. 1791526992843
The Agency may also consider alternative compliance approaches if they are appropriately justified and still meet the applicable regulatory requirements. 1791526992843
Impact on Medical Device Manufacturers and Importers
For manufacturers, importers and distributors operating in Canada, the updated guidance reinforces the need to maintain robust shortage and discontinuation procedures.
Key areas to review include:
monitoring whether products fall within the List of Specified Medical Devices;
identifying actual or anticipated shortages;
managing discontinuation reporting;
maintaining access to supply-chain information;
responding to Health Canada information requests;
coordinating responsibilities between manufacturers, importers and distributors;
updating internal SOPs before the new guidance takes effect.
Because Version 4 becomes effective on 17 June 2027, companies have a transition period to review their processes and documentation.
Supply Chain and Business Continuity
The guidance also highlights the regulatory importance of supply continuity.
Medical device shortage management is no longer only a commercial or logistics issue; it is also a regulatory obligation where specified devices are concerned.
Manufacturers and importers should therefore ensure that regulatory, quality, supply-chain and commercial teams have aligned processes for identifying and escalating shortage risks.
Effective Date
Although Version 4 was issued on 7 October 2026, it does not become effective until 17 June 2027.
Until then, Health Canada instructs regulated parties to continue referring to the existing guidance.
