Hello everyone,
As 2025 winds down, I wanted to share a summary of the key moments in the Canadian regulatory landscape and a couple thoughts on the US and EU.
In this issue
- Red Tape Reduction and Health Canada Modernization: MDEL Phase II, MDSAP Update and PMRA amendments abandoned
- Plastic Registries – New reporting requirements
- International update: US QMSR, In Vitro Diagnostics and AIaMD
- Announcements
Red Tape Reduction and Health Canada Modernization
Health Canada has conducted a broad review of regulations to identify opportunities to reduce red tape, including removing certain requirements and modernizing the approach to risk classification. The Directorate is also moving forward with key digital and policy initiatives such as the Regulatory Enrolment Process (REP) scheduled to become mandatory in Q1 2026 and the eSTAR program expansion to In Vitro Diagnostic Device (IVDD).
Other key policies focused on the Unique Device Identification (UDI) system and the publication of new guidance documents covering various topics like machine learning-enabled medical devices, the guidance for determining medical device application types, the guidance on using standards to support regulatory compliance, the guidance on significant change and the guidance on the updated ToC.
MDEL Phase II
Health Canada has opened a consultation for the second phase of amendments for medical device establishment licences including:
- Removal of the requirement for foreign distributors to hold an MDEL if they are selling their medical devices through Canadian importers already holding an MDEL.
- Clarifying the requirement that MDEL holders must establish, implement, and maintain documented procedures.
- Requiring all MDEL applicants and licence holders to provide a list of suppliers for the medical devices they import to or sell in Canada.
MDSAP
The Auditing Organization (AO) application process for the Medical Device Single Audit Program (MDSAP) was reopened for a limited 90-day window from July to the end of September, 2025. The program plans to periodically re-open application windows in the future, based on a “Measured Growth Strategy” to increase AO availability and address gaps in auditor coverage.
In addition, a new pilot program is underway for Medical Device Organizations (MDOs, organizations involved in design/manufacturing that are not the “legal” manufacturer). This limited opening is primarily implemented to address the needs of Brazil, Japan, and the US and is not expected to impact the Canadian regulatory framework.
Pest Control Product Regulations – Abandoned
Following the careful consideration of feedback from industry, the PMRA will not be moving forward with the proposed amendments.
Proposed PMRA amendments included facilitating access to confidential test data and making explicit the Minister of Health’s power to require applicants and registrants to submit information on cumulative effects of pest control products on the environment (CEE) and species at risk.
Federal Plastics Registry – New Reporting Requirement
The Federal Plastics Registry is a federal-level system that collects standardized data on plastics across their full life-cycle from manufacture or import, to sale, and to waste management for products placed on the Canadian market.
It requires various actors (resin manufacturers/importers; producers of plastic products; industrial, commercial or institutional waste generators; and service providers managing plastic waste) to report annually on types and quantities of plastic produced, sold, collected, reused, recycled, composted, incinerated, or landfilled.
Reporting is being introduced in phases:
- Phase 1 begins in September 2025 (covering 2024 data) and applies to plastic packaging, electronic/electrical products, and single-use items placed on the market. There are limited exemptions for small producers or waste handlers placing or managing under 1,000 kg/year.
- In 2026, Phase 2 adds reporting requirements for resin manufacturers and importers, as well as reporting on plastic placed on the market for the remaining categories. Phase 2 also introduces reporting on plastic waste generated at ICI facilities and plastic collected and sent for diversion and disposal for some categories.
- In 2027, Phase 3 adds reporting on plastics collected and sent for diversion and disposal in additional categories. Reporting requirements beyond 2027 would be detailed in a future information gathering notice. A simplified version of the phases is outlined in the table below.
The Federal Plastics Registry goal is to provide consistent, nationwide plastic-flow data to inform evidence-based decision-making, support a circular-plastics economy, and help monitor progress toward zero-plastic-waste objectives.
It is expected that this new requirement will have an impact on hospitals, clinics, and Medical Device Importers, sellers and manufacturers. You can read more about the requirements here.
International Update
US QMSR – Effective 02 February 2026
The #FDA’s new Quality Management System Regulation (QMSR), which becomes fully effective in February 2026, formally aligns 21 CFR 820 with ISO 13485:2016 to create a harmonized, globally consistent framework for medical device quality systems.
For manufacturers already certified to ISO 13485—and especially those operating under MDSAP—the transition is expected to be a low-effort exercise focused on tightening documentation, updating terminology, and addressing a small number of FDA-specific requirements such as labeling, packaging controls, and record-keeping expectations.
The FDA will not be taking ISO 13485 certifications as proof of compliance and will conduct the QMS audit themselves.
In Vitro Diagnostics Regulation
The European IVDR implementation remains challenging with limited notified body (NB) capacity and ongoing uncertainty around #EUDAMED, EURLs, and transitional timelines.
The 2024/1806 amendment brings revised transition deadlines for Class A, B and C devices but challenges persist for in-house devices under Article 5(5) and in aligning definitions of “health institution” across the EU. In addition, the overlap between horizontal regulations (e.g., AI Act, REACH, sustainability) risks duplicative oversight, highlighting the need for coordinated regulatory frameworks.
AIaMD and the EU AI Act
The EU AI Act, which will apply starting August 2027, represents a landmark in digital health oversight but faces implementation issues ranging from incomplete standards to unclear Notified Body designations, and limited post‑market infrastructure.
The emergence of regulatory sandboxes such as the MHRA AI Airlockreflects a pragmatic shift toward experimentation, collaboration, and evidence‑based adaptation.
The next two years will be decisive in determining whether Europe’s #AI regulation can both safeguard patients and enable progress in digital medicine.
2025 Highlights
- In October 2025, I had the opportunity to present on the Canadian Medical Device Regulations at the TOPRA Symposium 2025 in Berlin, Germany.
- The Annual Health Canada | Santé Canadaconference in Ottawa was yet another excellent showcase of Health Canada’s agility and commitment to global harmonization.
- In July 2025, I officially joined the Dental Industry Association of Canada – DIAC to support the organization with Regulatory and Quality policy matters and give a voice to the Canadian dental industry.
Ready to Bring Your Device to Market?
At QARALOGIC, we specialize in turning your Medtech journey into results—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.
📩 Reach out today to bring your device to the Canadian market with confidence. You can email me or book a call by visiting our website QARALOGIC.