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Leaning into Interpretive Flexibility: Reflections from the 2025 Health Canada MedTech Conference (9-12 June 2025)
- Hasnaa F.
- Jun 21
- 6 min read
“Leaning into interpretive flexibility.” This phrase—delivered by one of Health Canada | Santé Canada’s senior regulators during Medtech Canada’s annual regulatory and quality conference in Ottawa last week—captured the tone of an event that was, in many ways, an accurate depiction of Canada’s broader regulatory posture.
There’s measurable progress on file backlogs, renewed attention to transparency, and genuine efforts to engage with industry, e.g. the recent survey on the Medical Device Program. Yet, as someone who works daily with Canadian and global MedTech innovators, I left the event with mixed feelings. While the intent is commendable, the tools, policies and review culture still lag behind the complexity of today’s technologies. As another senior regulator from the Bureau put it "Money is not flowing!" and there will be even less with the new government.
Backlogs Down, But Class II Still a Drag
Let’s start with performance. Health Canada presented data showing 99–100% on-time performance for Class III and IV applications and significant improvements in Class II processing—particularly in screening, where some turnaround times have dropped significantly.
That’s the good news.
The reality, however, is that Class II timelines remain volatile. Only about 50–60% of Class II submissions meet performance targets. A year ago, nearly half were stuck in backlog. Internal reorganization and process tweaks have helped, but these gains are fragile and uneven across bureaus. The regulator is simply not resourced to meet the growing complexity and demand of the current MedTech landscape.
Deficiency Letters: The Art of Nitpicking
Health Canada presented the top three reasons for Class II deficiencies:
Application Type errors (particularly around licence type and family groupings)
Device name discrepancies (often over minor differences between the application form and the label)
Insufficient or inaccurate classification rationale
None of these should come as a surprise—but they raise a persistent issue: inconsistent interpretation of guidances, lack of published clarity and in some instances, incorrect information on Health Canada's own forms.
Device name mismatches, for example, remain a frustrating and avoidable barrier to market. If the label says “Acme Medical Nitrile Exam Gloves, Powder-Free, Chemo-Tested” and the application says something nearly identical, a rejection still occurs. Reviewers now rarely request a quick adjustment of the name or typo—they issue deficiency notices instead. Worse, the whole review process stops at the first deficiency, addressing that deficiency does not mean you will not get another one, and another one after that... Every round pushes out the final review and approval by at least ten days.
Classification: Interpretive Flexibility in Action
Another recurring theme was classification—particularly around Rule 9 and Rule 10 (Schedule 1), which govern devices that transmit energy or may pose immediate danger.
Health Canada encouraged sponsors to not just cite a comparator, but to "lean in" and clearly justify why a device is Class II instead of III.
The message to industry? Tell a story. Be proactive. Use pre-sub meetings and lean into the ambiguity.
Yes, I know.
Legacy Licences Are Regulatory Time Bombs
In what became one of the more sobering threads of the conference, Health Canada acknowledged that many older Class II licences, if reviewed today, would not meet current expectations.
Some attendees shared that even minor amendments to such licences triggered deficiency letters—or worse, rejections—due to structural issues with the original license that went unnoticed for years. Changes in how “family” is defined or how licence types are grouped can trigger re-review of old approvals.
This silent evolution of policy introduces significant regulatory risk for manufacturers. It also highlights the critical need for legacy licence clean-ups and a more transparent system for flagging at-risk licenses before they are used as anchors for new submissions.
eSTAR, REP & Digital Modernization: Still a Work in Progress
The conference included updates on Health Canada’s digital initiatives:
REP (Regulatory Enrolment Process) becomes mandatory in January 2026. It standardizes submission intake via a secure, integrated platform and will soon replace legacy channels.
In my article Precision Regulating- Health Canada's New Approach, I describe the REP process in great detail. Additionally, Health Canada organized two webinars through Medtech Canada on the REP. You can find here the English and French versions.
I asked one of Health Canada's representatives about the risk of using US-based IT infrastructure for the REP and was simply told: we think the risk is low.
I am still not sure of why it was designed this way in the first place or of the reason Health Canada is not providing clear answers on the topic.
Health Canada did mention that manufacturers with existing licences will receive IDs automatically, but new application sponsors should start now to avoid the expected last minute rush.
eSTAR: The template developed by the FDA was built with the ToC as a backbone. While the FDA accepts the tool as is, Health Canada requires conversion to the ToC structure prior to review start. The program is currently integrating feedback from the pilot; future iterations will incorporate the updated ToC, expected in Fall 2025, and include IVDs.
While the intent is clear—align with international regulators, streamline review—the execution feels piecemeal. Canada still lacks true eSubmission capability. PDF forms, manual conversions, and repeated data entry remain standard.
MDSAP: Expanding Scope, Growing Influence
The program is reopening applications for new Auditing Organizations under MDSAP. The agency hinted at deeper integration with #MDR and #IVDR frameworks, including shared audit structures. This could be a win for industry—especially as MedTech Europe pushes for wider recognition of MDSAP as a global auditing regime.
A new pilot program for Medical Device Organizations (MDO), e.g. Contract manufacturers, specification developers, previously not allowed into the MDSAP certification, is being developed and signals the overall intent to modernize and expand MDSAP.
Certification scope remains the Achilles heel. Misalignment between actual device manufacturer activities and audit scopes continues to trip up companies and Auditing Organizations.
Worth noting, the organization now has a brand new website: MDSAP.GLOBAL
MDEL holders brace for audits
Domestic inspections are to be expected onsite, especially the first time. Health Canada will use a risk-based approach to decide on the organizations to be audited.
Typically, 75% domestic, 25% outside (US, EU, and South Korea).
Common deficiencies include: labelling, MDEL application inaccuracies, incomplete records (distribution, incident reports, complaints, recalls), inadequate or missing procedures, sale of unlicensed devices.
Audits typically lasts from 1 to 5 days.
AI, Machine Learning, and the Digital Shift
Health Canada confirmed it is "using" AI—for now, mainly in administrative functions like machine translation and summarizing publicly available data.
Evaluators still lack access to AI tools developed for secure environments, and sandboxing, validation, and governance issues remain.
A new guidance on machine learning-enabled devices was finalized earlier this year. It
allows for lifecycle planning of adaptive algorithms and represents one of the first frameworks for continuous software evolution in Canadian regulation.
Final Thoughts: Intent Is Not Enough
I don’t fault Health Canada for struggling with limited resources, growing complexity, and a political environment that makes regulatory reform slow. The passion and dedication of the teams were evident in every session.
However, if you were hoping for updates on significant change guidance, UDI, combination products, 3D printing and other "contemporary" MedTech industry problems, I am afraid there is nothing on that front.
Interpretive flexibility and precision regulating are not a substitute for transparency, speed, and consistency. Innovators need clarity. Start-ups cannot afford five deficiency rounds. Distributors cannot wait 120 days for MDELs. And patients cannot receive novel therapies if combination products sit in bureaucratic limbo.
Ready to Bring Your Device to Market?
At QARALOGIC, we specialize in turning Health Canada’s complexity into compliance—and speed. Whether you’re preparing a Class II application, navigating MDSAP, or aligning with EU MDR, we’ve been there. And we know how to do it right the first time.
🔹 Need to fix an old licence? 🔹 Preparing for REP or ToC format? 🔹 Unsure how to justify a borderline classification? Let’s talk.
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