Health Canada Announces Changes to the Medical Device Special Access Program (SAP) Application Process (August 24, 2026)

Health Canada Issues Notice on Changes to the Medical Device Special Access Program (SAP) Application Process

On August 24, 2026, Health Canada published a formal notice regarding changes to the application process for the Medical Device Special Access Program (SAP). The notice introduces an accessible application form and a secure transmission tool, and confirms that from February 1, 2027, only the new form and the new submission method will be accepted. The changes affect companies, healthcare institutions and local representatives that need to apply for Canadian medical device special access authorization, and involve adjustments to application documents, submission channels and internal operating procedures.

Source and Applicability

• Source body: Health Canada Medical Devices Announcements
• Original publication date: August 24, 2026
• AIMEILI article publication date: August 25, 2026
• Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices/changes-application-process-notice.html

This article is compiled and translated from publicly available information published by Health Canada Medical Devices Announcements. Specific requirements remain subject to the latest formal publications of the regulatory authority.

Full Translation of the Notice

Health Canada has issued a notice on changes to the application process for the Medical Device Special Access Program (SAP).

On This Page

• About the changes
• The new accessible application form
• The new secure way to submit information
• Timelines and actions to take
• Contact us

About the Changes

We are making changes to the application process for the Medical Device Special Access Program (SAP). These changes will:

• reduce errors
• better protect your information
• create a clearer and more consistent process
• make it easier to apply for medical device SAP authorization

The changes include the introduction of:

• an accessible application form
• a new secure way to submit information

The New Accessible Application Form

We have created a new accessible PDF application form.

The new form:

• is clearer and easier to use
• meets our accessibility standards
• will help process applications more efficiently

The New Secure Way to Submit Information

We now provide a new secure way to submit SAP applications.

This method:

• speeds up intake and processing
• keeps patient and clinical information secure during transmission

To obtain the fastest processing, we recommend submitting applications using the secure transmission tool. If you are unable to use the tool, you can fax your information to 613-957-1596.

We do not monitor the inbox outside of our regular business hours.

Timelines and Actions to Take

You can start using the new accessible application form and the new submission method now.

Actions to take:

• Download and start using the Special Access Medical Device Application Form (PDF) and our electronic spreadsheet template.
• Submit your medical device SAP application using the secure transmission tool (recommended) or by fax.
• Update your clinic workflows, templates, or saved links that are now out of date.

Adobe Reader Recommended

This form contains validation and other interactive features and may not work properly when opened in a web browser. For full functionality, download the form and open it in Adobe Acrobat Reader.

As of February 1, 2027, Health Canada will only accept applications submitted using the forms and submission methods described in this notice.

Access Other Resources

• Applying for access to medical devices through the Special Access Program
• Guidance document for health professionals on special access and custom-made medical devices

If you have any questions or concerns during the transition period, please contact us:

• Special Access Program
• Medical Devices Directorate
• Health Canada
• Email: sap.devices.mdb@hc-sc.gc.ca

AIMEILI Regulatory Interpretation

What This Means for Medical Device Companies

When Health Canada Medical Devices Announcements publishes an update of this kind, companies should first determine whether it concerns regulatory policy, guidance and standards, recalls and safety, product performance, quality systems, or post-market surveillance. Each information type has a different impact on registration pathways, technical documentation, labelling and instructions for use, risk management and market maintenance, and it should not be treated simply as industry news.

For Chinese medical device manufacturers, the priority is to convert the news into executable compliance actions: confirm whether the change involves the same type of product, the same technology route or the same risk points; verify whether existing documentation still supports the requirements of the target market; and where necessary, update risk management, performance verification, clinical evaluation, labelling and instructions for use, distributor communication and post-market surveillance records.

Which Documents Should Companies Review First?

We recommend reviewing product intended use, classification rationale, ISO 13485 quality system evidence, risk management files, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, authorization documents and existing registration certificates as a priority.

Common Risks

Common risks include unclear classification decisions, an incomplete evidence chain, non-localized labelling and instructions for use, unclear responsibilities of the authorized representative, and inadequate post-market maintenance arrangements.

AIMEILI View

The Health Canada adjustment to the Medical Device Special Access Program (SAP) application process appears at first to be a form upgrade and a change of submission channel, but in substance it reflects a broader tightening by the regulator in the areas of risk management, data security and administrative efficiency. For Chinese medical device companies that intend to enter or already operate in the Canadian market, the SAP route is an important relief pathway for products that do not yet hold a regular market authorization but are clinically urgent. This notice therefore directly affects a company's emergency access capability and compliance arrangements.

From the perspective of the registration pathway, an SAP application is not equivalent to a regular medical device licence, but the quality of the application materials and the compliance of the submission method directly affect the speed at which clinical use is authorized. The new form has been optimized for readability and accessibility, which signals that Health Canada will place greater emphasis on the completeness and consistency of application content. Companies should accordingly re-organize core materials such as the product indications, the justification of clinical urgency and safety evidence, and ensure that the new PDF form and electronic spreadsheet template are used exclusively before the mandatory implementation date of February 1, 2027, avoiding refusal or delay caused by a non-conforming form format.

In terms of technical documentation and clinical evaluation, the new application form is likely to impose clearer requirements on the justification of clinical need. Companies need to update the clinical evaluation summary, benefit-risk analysis and intended use description in the SAP application in light of Canadian clinical practice and gaps in existing treatment options. In particular, for products that require compassionate use or emergency use assessment in Canada, the clinical evidence chain must be clear and the data traceable, in order to align with the stricter review that Health Canada may apply after the transition period.

In addition, the new secure submission method emphasizes the confidentiality of patient information and clinical data during transmission. This is a reminder to exporting companies that they must pay attention to compliance requirements for cross-border data transfer and privacy protection. When submitting SAP applications that contain patient personal information, healthcare institution information or clinical trial data, companies should assess whether additional encryption measures are required or whether submission should be completed through a local authorized representative. Health Canada recommends the secure transmission tool as the primary channel and treats fax only as a fallback, which requires companies and their local representatives to complete the technical connection and internal training for the secure tool in a timely manner.

With respect to local representatives and post-market maintenance, this change means that registered Canadian authorized representatives or importers may need to update their SAP application operating procedures. Companies should proactively confirm with their representatives the download source of the new form, the completion rules for the electronic spreadsheet template and access rights to the secure transmission tool, while updating internal standard operating procedures (SOPs) to ensure the transition is completed before February 1, 2027. If a company previously relied on the old email or fax channel to submit SAP applications, it must adjust as soon as possible; otherwise the availability of medical devices for urgent patients may be affected and subsequent registration plans may be delayed.

Finally, from the perspective of regulatory trends, Health Canada is bringing special pathways such as special access into a more standardized and digitalized management framework. Chinese companies should not treat SAP as a temporary operation separate from routine registration, but should integrate it into the overall Canadian registration strategy of the medical device product. Companies are advised to use the transition period to refine the clinical evaluation chapters, risk management reports and labelling information in the technical documentation in line with the new form requirements, laying the groundwork for a subsequent regular market application or amendment that may be required. At the same time, companies should monitor accessibility form completion guidance and cybersecurity-related requirements that Health Canada may publish in the future, so that data security and documentation completeness do not become weak points while submission channels are upgraded.

Business Impact

• Emergency access timelines: Applications that do not use the new accessible PDF form and electronic spreadsheet template risk refusal or delay after February 1, 2027, which may affect access to medical devices for urgent patients.
• Submission channel reconfiguration: The secure transmission tool becomes the recommended channel, with fax retained only as a fallback. Companies and their local representatives must complete technical connection, access rights and staff training before the mandatory date.
• Data protection obligations: SAP applications that include patient or clinical information must be assessed for cross-border transfer, encryption and privacy compliance, and consideration should be given to submitting through a local authorized representative.
• Clinical justification quality: The justification of clinical need, benefit-risk analysis and intended use description in the SAP application should be updated against Canadian clinical practice and current treatment gaps, with a traceable clinical evidence chain.
• Internal process updates: Standard operating procedures, templates, saved links and clinic workflows referencing the previous application process must be revised to align with the new form and submission method.
• Alignment with registration strategy: SAP should be integrated into the overall Canadian registration strategy rather than managed as an isolated temporary operation, so that technical documentation upgrades also support future regular applications or amendments.

FAQ

Can the Health Canada notice of August 24, 2026 on the Medical Device Special Access Program (SAP) application process be used directly as a basis for submission?

No. This article is intended for preliminary understanding and project assessment only. A formal submission must still be based on the latest requirements of the target country's regulatory authority, the product classification conclusion and the company's actual documentation status.

What should a company do first after seeing this update?

A documentation gap assessment should be carried out first, to confirm whether the update affects the registration pathway, technical documentation, labelling and instructions for use, the quality system or post-market maintenance arrangements, and to define the actions and timeline needed to complete the transition before February 1, 2027.

Content Review and Scope

• Content author: AIMEILI Regulatory Editorial Team
• Professional review: AIMEILI Medical Device International Registration Project Team
• Source principle: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting judgement.
• Scope: This article is intended for preliminary understanding, documentation preparation and project planning, and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.

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