October Issue: Latest Medical Device Regulatory Updates

Qaralogic newsletter, October 2026.

A lot has moved since the summer break. The most important change is the simplest: Health Canada has told high-risk device applicants, in writing, that sending everything is now slowing them down.

Main story: the “send everything” dossier has become a liability

On 16 July, Health Canada issued a notice to industry on Class III and IV medical device licence applications. Its message is unusually blunt. The Medical Devices Directorate has seen “a significant increase in the volume of information submitted”, and it warns that “including large amounts of unnecessary information can delay the review process.” Information whose relevance is unclear may trigger requests for clarification. Duplicated content can lengthen review times. Health Canada’s instruction is simple: “Submit only the information needed to support your application.”

Over the years, we have witnessed several manufacturers export their full US submissions or EU technical files and leave the work to the reviewer to find what they need. Health Canada has now publicly named this strategy as a cause of delay. Health Canada’s own figures show the cost: a new Class III application averages 210 days from filing to decision, and about 70 of those days are spent on the manufacturer’s end, answering questions. Every clarification request adds to the clock.

The notice also says that applications must include summaries of the studies and evidence submitted, and that companies using AI tools to draft those summaries remain responsible for their accuracy. Summaries are where the reviewer forms a first view of your file. A summary that does not match the data underneath erodes the submission credibility.

Who should act

• US and EU manufacturers entering Canada: a dossier built for the FDA or a Notified Body is not a Health Canada dossier. Selection and summarisation for the Canadian reviewer is now an explicit expectation, not a nicety.
• Pharma companies building combination devices: drug submissions reward completeness. Device reviewers here are asking for relevance. That cultural shift catches drug regulatory teams off guard.
• Startups with a Class III/IV device: a lean, well-argued file is cheaper to prepare and faster to review.

On the radar

• Shortages and discontinuations go public in June 2027. Health Canada published updated guidance on 7 October (GUI-0137) for amended rules that take effect 17 June 2027. Manufacturers will post shortages, and every discontinuation, on a public website, with discontinuations announced at least 12 months ahead where possible. A companion guide (GUI-0147) adds a duty to tell Health Canada of changes to a foreign authorization used for exceptional importation.Who should care: anyone rationalizing a Canadian portfolio, since a product exit now becomes a public, dated commitment. (Health Canada)
• MDEL Phase 2 comes into force 14 December 2026. Foreign distributors selling through a Canadian importer that already holds a Medical Device Establishment Licence (MDEL) will no longer need their own. MDEL holders must maintain documented procedures and list their suppliers. Who should care: importers, distributors and anyone restructuring a Canadian supply chain. (Health Canada)
• Change control for AI software is converging. IMDRF finalised its principles for Predetermined Change Control Plans (PCCPs) in August, letting software makers pre-agree future model changes with regulators. Health Canada’s machine learning guidance already accepts PCCPs with Class II to IV applications, and the UK has committed to draft guidance on changes to AI devices by December. Who should care: teams building software as a AI/ML-enabled medical devices (SaMD) for more than one market. (IMDRF, Health Canada)

From the room: Health Canada wants to fix how incident reports arrive

At a recent session Medical Device Problem Reports: Addressing challenges in electronic submission and data ingestion, September 2026, Health Canada’s medical device problem reporting team shared that only about 15% of mandatory problem reports reach Health Canada in a form its systems can read automatically. The rest arrive as flattened PDFs, look-alike forms with different underlying data, or entirely home-made formats, and someone has to re-key them.

The fix on the table is a structured XML submission. The options presented range from sharing the existing, admittedly fragile XML to building a new one aligned with the formats other regulators already use (the GHTF N87 structure behind the EU’s Manufacturer Incident Report) and with room for IMDRF adverse event codes. Health Canada is asking industry whether XML would fit their workflows and what could stands in the way.

Also during this period

Canada

• 29 July: final guidance on registering clinical trials and disclosing results now covers investigational testing for Class II to IV devices. (link)
• 24 August: new Special Access Program form and secure submission route; mandatory from 1 February 2027. (link)
• 2 September: exceptional importation forms move online, and shipment notice drops from five to three business days. (link)
• 25 September: the recognized standards consultation closed; feedback is now accepted year-round. (link)
• International – MDSAP
• July: revision 11 of the Audit Approach, the second this year after February’s alignment with the FDA’s new Quality Management System Regulation (QMSR). (link)
• EU, July to September
• -MDCG 2026-5 on UDI assignment between manufacturers and distributors, and MDCG 2020-16 rev.5 on IVD classification rules. (link)
• -Team-NB updated its MDR certification process consensus paper, and DIGICAP, an EU-funded project led by Team-NB with MedTech Europe, began work to digitise MDR and IVDR conformity assessment. (Team-NB, CORDIS)
• FDA, 18 August: discussion paper on generative AI-enabled devices; feedback due 19 October. (link)
• TGA, August to October: consultation on publishing more post-market review findings for devices (closed 2 October); UDI now required for Class IIb and III devices in Australia since 1 July. (link)
• UK, 6 October: government accepts all 44 recommendations of its AI in healthcare commission; the MHRA’s AI Airlock sandbox opens Phase 3. CE marked devices remain accepted in Great Britain until 2028 or 2030 depending on type. (AI commission, MHRA)

Since our last issue

• Regulatory Enrolment Process (REP) now mandatory for Class II to IV licence applications and amendments (Health Canada notice, 24 April). (link)
• EUDAMED: four modules (actors, UDI and device registration, Notified Bodies and certificates, market surveillance) became mandatory on 28 May. (link)
• ISO/TS 24971-2:2026 (June) applies ISO 14971 risk management to machine learning devices; generative AI is out of scope. (link)
• MDEL Phase 2 and the shortages amendments were both published in Canada Gazette Part II on 17 June. (link)

Health Canada review times

Average days from application to decision, September 2025 to August 2026 (Health Canada performance metrics, last updated 22 September 2026):

About a third of a Class III or IV review clock sits with the manufacturer, which is the part a cleaner file shortens. Combination products average more than two years.

Key dates

• 19 October 2026: FDA feedback deadline on generative AI-enabled devices.
• December 2026: MHRA draft guidance on changes to AI-enabled devices (UK).
• 3 December 2026: European Parliament health committee vote on the MDR/IVDR targeted revision (scheduled).
• 14 December 2026: MDEL Phase 2 amendments come into force.
• 1 February 2027: new Special Access Program form becomes mandatory.
• 17 June 2027: public shortage and discontinuation posting rules take effect.

From Qaralogic

• Course series on Canadian medical device regulations. We preparing a course series for teams that need to understand how Health Canada really works, not just what the regulations say. Express your interest using our contact form.
• Before you file in Canada : A new Class III application takes 210 days on average, and about 70 of those days are spent answering Health Canada’s questions. Much of that time is avoidable. If you are preparing a Class III or IV submission from an FDA or EU file, book a 30-minute Canada readiness call before you file. She will show you where Health Canada is likely to push back, what to leave out, and what your file needs to make the case on its own. Right the first time. Book your 30-minute Canada readiness call.