MDEL Annual Licence Review and Change Notices Before April 1

1. Key takeaways

MDEL holders carry two continuing obligations. The first is the Annual Licence Review (ALR): under paragraph 46.1(1), a review application must be submitted to the Minister before April 1 of each year, together with updates to the information and documents described in section 45. The second is change notification: if the information in paragraphs 45(a) and (b) changes, Health Canada must be notified within 15 calendar days.

• The ALR deadline is a fixed statutory date of April 1 every year for holders whose licence is not suspended.
• The ALR must include updates to the section 45 information and documents, not a bare confirmation that nothing has changed.
• The 15-calendar-day notification duty applies only to changes in the information listed in paragraphs 45(a) and (b).
• Supplier information must be refreshed at each ALR under the new paragraphs 45(f.1) and (f.2), effective December 14, 2026.
• The right-to-sell annual fee for MDL holders is a separate annual obligation and must be planned independently of the ALR.

2. Legal basis

The two obligations rest on the amended Regulations and on Health Canada guidance. The table below lists the instruments relied on, the provisions concerned, the relevant dates and where each can be verified.

Read together, these sources establish a simple split of duties: anything that falls under paragraphs 45(a) and (b) moves on a 15-day clock, while everything else in section 45 is updated through the annual review cycle that closes before April 1.

3. Expert insights

Insight 1: April 1 is a statutory date, not a fiscal-year starting point.

Under paragraph 46.1(1), the annual licence review application must be submitted before April 1 of each year. This coincides with the date on which Health Canada switches its official fees to the new annual rates (April 1). Companies can therefore consolidate the two categories of April 1 items in a single annual compliance calendar: the ALR submission on the regulatory side and the new fee schedule on the financial side. Treating these as one combined April workload reduces the risk that either item is overlooked during a busy reporting season.

Insight 2: the ALR requires updates, not a confirmation of no change.

As amended by SOR/2026-110, paragraph 46.1(1) expressly requires that the review application include the information and documents described in section 45, including any updates to that information or those documents. This means the ALR is not a tick-box exercise in which the holder simply confirms that nothing has changed. The holder is expected to actually go through each item, verify it against current facts, and submit genuine updates where anything has moved. A review submission prepared without a genuine reconciliation exercise would not meet the intent of the amended provision, and discrepancies discovered later during an inspection would be harder to explain than updates filed through the review itself.

Insight 3: the 15-calendar-day change notification applies only to paragraph 45(a) and (b) information.

The wording of GUI-0016 is that where the information in paragraphs 45(a) and (b) changes, Health Canada must be notified within 15 calendar days. Updates to other information are handled through the ALR instead. This division of labour must be written clearly into internal procedures; otherwise notifications that belong on the fast track can end up waiting for the annual cycle, which is precisely the kind of omission the short deadline is designed to prevent. In practice, the fastest way to make the split fail is to leave the classification decision to whoever happens to be processing the change on a given day, so the rule that decides which track applies should be fixed in the procedure document itself rather than left to interpretation at the moment a change occurs.

Insight 4: the ALR and the right-to-sell annual fee are two independent annual tracks.

The ALR for the MDEL follows paragraph 46.1(1). The right-to-sell annual fee for MDL holders follows section 77 of the Order Setting Out the Fees Payable for Drugs and Medical Devices (CAD 460, as of April 1, 2026). The two items have different responsible parties, different legal bases and different mechanics, so they must be arranged separately even though both run on an annual rhythm anchored around April 1.

4. Practical recommendations

• Build an annual compliance calendar: complete the MDEL ALR before April 1, and in the same window confirm the MDL right-to-sell annual fee.
• Reconcile the ALR item by item against section 45 and update it, rather than ticking a box marked no change.
• Split the change-management process into two tracks: paragraph 45(a)(b) information triggers a notification within 15 calendar days; other information goes into the ALR update.
• Refresh supplier information at each ALR under the new paragraphs 45(f.1)(f.2), effective December 14, 2026.
• Keep proof of submission for every ALR and every change notification.

5. Verification checklist

• □ Calendar reminders are set for completing the ALR before April 1
• □ The ALR has been reconciled and updated item by item against section 45, including supplier information
• □ A process is in place for notifying paragraph 45(a)(b) changes within 15 calendar days
• □ The MDL right-to-sell annual fee (CAD 460) is planned separately from the ALR
• □ Proof of submission for ALRs and change notifications is archived
• □ Internal procedures clearly separate change notifications from ALR updates

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