Health Canada Announces Changes to Special Access Program Application Process for Medical Devices
Health Canada has announced changes to the application process for the Special Access Program for medical devices.
The notice was published on 24 August 2026 and explains new requirements intended to make the application process clearer, more consistent and easier to use.
Purpose of the Changes
Health Canada states that the changes are intended to:
reduce errors;
better protect information;
create a clearer and more consistent process;
make it easier to apply for medical device Special Access Program authorization.
The changes include the introduction of an accessible application form and a new secure method for submitting information.
New Accessible Application Form
Health Canada has created a new accessible PDF application form.
According to the notice, the new form is clearer and easier to use, meets accessibility standards and is expected to help Health Canada process applications more efficiently.
Health Canada also recommends downloading the form and opening it in Adobe Acrobat Reader, because validation and other interactive features may not function correctly when the form is opened in a web browser.
New Secure Submission Method
The notice also introduces a new secure submission method for medical device SAP applications.
Health Canada explains that the method is intended to speed up intake and processing while keeping patient and clinical information secure during transmission.
For the fastest processing time, Health Canada recommends using the secure submission tool. If this is not possible, applications may still be submitted by fax.
Timeline and Transition
Health Canada states that applicants may start using the new accessible application form and secure submission method now.
During the transition, users are advised to download and start using the new application form and spreadsheet template, submit SAP requests through the secure transmission tool or by fax, and update clinic workflows, templates or saved links that are now out of date.
From 1 February 2027, Health Canada will only accept applications using the form and transmission methods described in the notice.
Impact on Medical Device Manufacturers and Healthcare Professionals
For healthcare professionals, clinics and organizations using the Special Access Program for medical devices, the notice introduces practical changes that should be incorporated into internal workflows before the February 2027 deadline.
Stakeholders should pay particular attention to:
use of the new accessible PDF form;
use of the spreadsheet template;
secure transmission tool submission;
fax as an alternative submission route;
protection of patient and clinical information;
workflow, template and saved-link updates;
Adobe Acrobat Reader compatibility;
transition planning before 1 February 2027.
For medical device manufacturers, the update is relevant because healthcare professionals seeking access to non-authorized medical devices through the SAP may need updated support materials, accurate product information and awareness of the new submission process.
