Special Access Programme and Custom-Made Devices

1. Key takeaways

The Special Access Programme (SAP) and custom-made devices are two of Canada’s exemption channels. Under the Health Canada fee page, both custom-made devices and devices for special access fall among the four categories that are exempt from the device licence and therefore attract no fee. What is exempted, however, is the device licence and its fee — not the full set of post-market obligations. Importers and distributors of such devices remain within the scope of the MDEL requirement, and the event reporting and recall obligations of the Regulations continue to apply in the situations where the Regulations make them applicable. The exemption channels are pathways for individual need, not alternatives to routine commercial licensing.

• Custom-made devices and special access devices are exempt from the device licence and incur no fee.
• They belong to the official list of four exempt categories, alongside Class I devices and investigational testing devices.
• The exemption removes the MDL, not the obligations: the MDEL under Section 44 still applies to importers and distributors.
• Event reporting (Sections 59–61) and recall obligations (Sections 63.2, 64, 65) still apply in their applicable situations.
• The channels are designed for individual cases, not for scaled distribution.

2. Legal basis

The table below lists the sources for the exemption pathways: the fee page listing of the four exempt categories, the correspondence between the two licence types and classification, the provisions that keep obligations in force, and the official encouragement of consumer reporting.

3. Expert insights

Insight 1: The list of four exempt categories is an official enumeration, not a derived conclusion.

The Health Canada fee page explicitly lists the four categories exempt from the device licence: Class I devices, custom-made devices, devices for special access, and devices for investigational testing involving human subjects. What the four share is that they do not follow the ordinary licensing path, but each has its own conditions of application, and they cannot be substituted for one another. A device that qualifies for one exemption does not thereby qualify for another, and the conditions for each — the individualisation of a custom-made device, the patient-specific circumstances of special access — must be established on their own terms rather than by analogy from one category to the next.

Insight 2: Licence exemption and obligation exemption are two different things.

Exemption from the device licence means no MDL is required and no MDL application fee is generated. But the entities importing and distributing such devices remain bound by the MDEL requirement of Section 44, and the event reporting obligations of the manufacturer and importer (Sections 59–61) and the recall obligations (Sections 63.2, 64, 65) must still be fulfilled in the applicable situations under the Regulations. The licence and the safety obligations are separate regulatory layers: the first is removed for these devices, the second is not. Planning an exemption pathway therefore means planning the MDEL and the vigilance infrastructure alongside it, not assuming that the exemption simplifies the compliance footprint as a whole.

Insight 3: The sale of unauthorised devices is an explicitly encouraged reporting item.

The official Health Canada page explicitly encourages consumers to report device problems, including the sale of unauthorised devices. This means that once an exemption channel is crossed — for example, selling a device that requires a licence as if it were an exempt device — the activity enters the regulatory field of view directly, through a reporting channel aimed at the public. The boundary of the exemption channels is, in practical terms, externally policed. A company using these channels should treat the boundary not as an internal interpretation but as a hard limit, because the party most likely to surface an overreach is a member of the public with an easy reporting route.

Insight 4: The premise of the exemption pathways is individual cases, not volume.

Both custom-made devices and special access exist to address unmet needs of individual patients or special situations; they are not alternative pathways for routine commercial sale. Using an exemption channel for scaled distribution runs against the design of the regime. The test to apply is simple in direction: if the device or the use pattern can be brought inside the ordinary licensing system, that is where it belongs, and the exemption channels should be reserved for the situations they were created for.

4. Practical recommendations

• First check whether the device falls within one of the four officially listed exempt categories, item by item, and do not proceed by analogy.
• Even though exempt devices have no MDL, the importer’s MDEL must still be arranged and kept valid.
• Establish a mechanism for re-reviewing the applicability of the exemption pathway, to prevent distribution from drifting into volume sales.
• Establish event reporting and recall procedures in parallel for the applicable situations; the exemption must not leave them absent.
• Clarify in the agreements with the Canadian importer the scope of application of the exempt device and the record-keeping responsibilities.

5. Verification checklist

• □ The device has been checked item by item against the four exempt categories
• □ The importer’s MDEL has been arranged and is kept valid
• □ A mechanism for re-reviewing the applicability of the exemption pathway is in place
• □ Event reporting and recall procedures have been established for the applicable situations
• □ The agreements specify the scope of application of the exempt device and the record-keeping responsibilities
• □ The exemption channel has not been used to cover scaled sales that require ordinary licensing

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com