New Supplier Information and Documented Procedures Requirements for MDEL Applicants

1. Key takeaways

From December 14, 2026, MDEL applicants must provide two new items of information: new paragraph 45(f.1) requires the name and address of any person, other than a manufacturer, from whom the applicant has purchased devices for import or for distribution purposes; new paragraph 45(f.2) requires, for each such person, the class or classes of devices that the applicant is importing or distributing from them. At the same time, five documented procedure obligations change from a declaration into express requirements of the Regulations.

• Supplier information is captured at the level of name, address and device class, per supplier.
• The new items apply to every supplier except manufacturers, and must cover all suppliers in the applicant’s chain.
• Supplier information becomes an annually refreshed item through the amended ALR under paragraph 46.1(1).
• Section 58.1 is an entirely new provision covering six activities for Class II to IV devices, including corrective actions.
• Sections 59(3) and 59(4) layer the reporting procedure duties differently for Class I and for Class II to IV devices.

2. Legal basis

The new requirements come from discrete items of SOR/2026-110, each with its own section of the amended Regulations. The table below lists the items, what each adds or replaces, and the common effective date.

Because every item shares the same effective date, the compliance work for the supplier information and the five procedure duties can be planned as one programme with a single deadline, even though the underlying provisions address different activities across the product lifecycle.

3. Expert insights

Insight 1: the granularity of supplier information is the class, not the individual device.

New paragraph 45(f.2) requires, for “each person referred to in paragraph 45(f.1), other than a manufacturer, the class or classes of devices that the person is importing or distributing from that person”. This lowers the granularity required for maintaining the information: it is maintained by class rather than device by device, but it must still cover every supplier. For a company with a long supplier list, that difference is material to the maintenance workload, since a single supplier may serve an entire class of products without the company needing to enumerate each catalogue item underneath.

Insight 2: supplier information must be refreshed at the ALR; it is not a one-time submission.

In combination with the amended paragraph 46.1(1), under which the ALR must include updates to the section 45 information and documents, supplier information becomes an item that is refreshed every year. Companies should set up an annual review mechanism for their supplier list, with named ownership, so that changes in the supply chain during the year are collected continuously and reconciled once at the review rather than reconstructed from memory when the deadline arrives.

Insight 3: section 58.1 is an entirely new provision covering six activities.

The new section 58.1 applies to Class II, III or IV devices and requires manufacturers, importers and distributors each to establish, implement and maintain documented procedures for, as applicable to them, the handling, storage, delivery, installation and servicing of devices, and for corrective actions taken in respect of devices. This is the complete list of six activities. The word each matters: the duty attaches separately to every licence holder in the chain according to the activities it actually performs, so each company must scope the six activities against its own role rather than relying on another party’s procedures.

Insight 4: sections 59(3) and 59(4) are layered by device class.

Section 59(3) targets manufacturers and importers of Class I devices (covering preliminary and final reports under subsections 59(1) and (1.1), including foreign events); section 59(4) targets manufacturers and importers of Class II to IV devices (covering reports under subsection 59(1)). The scope of the required procedures differs between the two groups, so a company handling devices of different classes must establish the respective procedures separately rather than assuming one reporting procedure covers both regimes.

4. Practical recommendations

• Build a supplier list with three columns: supplier name, address and device class, reviewed annually.
• Compare existing documentation against each of the five procedures: distribution records (52(3)), complaint handling and others (58), the six Class II to IV activities (58.1), event reporting (59(3)(4)), and provision of information (61.2(4)).
• Confirm applicability activity by activity for section 58.1, and do not omit corrective actions.
• Establish the Class I and Class II to IV event reporting procedures separately (sections 59(3) and 59(4)).
• Complete remediation before December 14, 2026 with operating records in place, not just documents on a shelf.

5. Verification checklist

• □ The supplier list with three columns (name, address, device class) is established
• □ Supplier information is included in the annual ALR refresh mechanism
• □ The five documented procedures have been compared and completed one by one
• □ Applicability of the six activities in section 58.1 has been confirmed activity by activity
• □ The Class I and Class II to IV event reporting procedures are established separately
• □ Remediation is scheduled to complete before December 14, 2026

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