Regulatory and Quality

The event “Enhancing Engagement and Understanding of the MDSAP Program: Industry and Auditing Organization Perspectives” brought together stakeholders from Medtech Canada, BSI, and the broader medical device community to strengthen collaboration and shared understanding of the Medical Device Single Audit Program (MDSAP).

Held on November 13, 2025, the session was delivered in a hybrid format, enabling both in‑person and virtual participation from regulatory professionals, quality managers, auditors, manufacturers, and distributors. The program was designed to foster open dialogue between industry and auditing organizations on how MDSAP affects regulatory compliance, quality management systems, and access to global markets.

Presentations and panel discussions explored the evolution of MDSAP, its governance structure, and its expansion across multiple jurisdictions. Industry speakers shared practical experiences related to certification pathways, audit preparation, and maintaining robust quality systems, while auditing organization representatives provided insights into audit processes, auditor qualification, and opportunities to better align MDSAP with other regulatory frameworks, including the EU MDR.

Participants also discussed ongoing challenges, such as audit costs, report clarity, auditor expertise, and regulatory complexity—particularly for small and medium‑sized enterprises. Emphasis was placed on the need for improved education, clearer guidance, and more effective feedback mechanisms to support continuous improvement across the program.

Overall, the session reinforced the importance of transparency, collaboration, and continuous dialogue among regulators, auditing organizations, and industry to enhance the effectiveness of MDSAP and support innovation, patient safety, and global health outcomes.

Medtech Canada’s submission responds to Consultation CG1 published in the *Canada Gazette, Part I*, concerning the federal assessment of the Selected C3–C5 Alcohols Group and related substances under the *Canadian Environmental Protection Act, 1999* (CEPA). The submission focuses on the implications of proposed risk‑management measures for medical devices and healthcare furnishings used in clinical environments.

At a high level, Medtech Canada questions whether products such as mattresses, upholstered furniture, and other polymer‑foam–containing items used in healthcare settings were appropriately considered in exposure assessments. The association emphasizes that medical‑grade products differ fundamentally from consumer goods due to their performance requirements, infection‑control standards, and patient‑safety functions. As a result, Medtech Canada strongly recommends that any proposed actions to reduce dermal exposure to flame retardants such as TPHP or TBOEP explicitly exempt medical devices and healthcare furnishings. They warn that applying consumer‑oriented restrictions to medical products could create regulatory conflicts, compromise patient safety, and disrupt access to essential clinical equipment.

The submission also raises concerns about the scientific and policy basis for adding TPHP and TBOEP to CEPA Schedule 1. Medtech Canada notes ongoing uncertainties related to exposure pathways and health‑effects data and requests clearer justification for classifying these substances as harmful. The association further calls for coordinated decision‑making across regulatory regimes, including fire codes and consumer product safety frameworks, particularly where flammability standards and flame‑retardant requirements intersect.

Finally, Medtech Canada highlights the downstream challenges that restrictions or bans on chemical additives could pose for medical device manufacturers. Because many additives are proprietary and not disclosed, manufacturers may be unaware of affected substances. The association therefore seeks either explicit exemptions for medical technologies or, at minimum, sufficient transition periods to validate alternatives, complete regulatory approvals, and maintain continuity of supply for life‑saving products. The submission underscores the need for ongoing engagement with the medical device sector in future risk‑management discussions.

Medtech Canada submitted a consolidated response on January 16, 2026 to Health Canada’s consultation regarding proposed amendments to the **Medical Device Establishment Licence (MDEL)** regulations and related guidance documents. The submission reflects input from Medtech Canada members and a dedicated working group and responds to proposals published in *Canada Gazette I, Vol. 159, No. 45*. Overall, members support the intent to modernize and clarify the regulatory framework but raised significant concerns about implementation, clarity, and administrative burden.

For the **proposed MDEL regulatory amendments**, Medtech Canada requested updated cost estimates reflecting 2025 values rather than outdated 2012 assumptions, noting a substantially higher administrative burden. Members also questioned the need for annual submission of procedures, sought clarity on grandfathering during transition periods, and flagged problematic definitions related to Class I manufacturers, importers, distributors, and retailer exemptions. Ambiguous wording in Subsection 44(4) was highlighted as creating uncertainty around licence-holding responsibilities.

Feedback on **GUI‑0016 (MDEL Requirements)** focused on the need for clearer language, alignment with MDSAP practices, improved structure, and corrected examples—particularly for Class I manufacturers, service providers, and entities with dual roles. Members emphasized consistency in terminology and clearer site‑listing requirements.

Regarding **GUI‑0064 (MDEL Inspections)**, Medtech Canada recommended updates to inspection categories to reflect Health Canada’s risk‑based approach and requested clearer timelines, improved process flowcharts, and better guidance on CAPAs, inspection preparation, and reporting practices.

For **GUI‑0079 (Inspection Rating and Risk Classification)**, members sought clearer definitions, streamlined structure, removal of out‑of‑scope examples, and transparency around risk ratings and dispute timelines.

Finally, feedback on **FRM‑0292 (MDEL Application Form)** called for reordering steps to match real workflows, reducing duplication, clarifying manufacturer versus supplier roles, enabling spreadsheet uploads, and improving clarity for small businesses and international applicants.

Health Canada has released a Notice to Industry to support manufacturers preparing new Class III and Class IV licence applications for diagnostic ultrasound systems and transducers. The notice is intended to clarify regulatory expectations, standard references, and acceptable acoustic output limits to ensure patient safety and regulatory compliance.

The notice reiterates that applications must comply with the Medical Devices Regulations and align with recognized guidance and standards. Manufacturers are directed to consult Health Canada medical device guidance documents, standards compliance guidance, the list of recognized standards, and the IMDRF table of contents for medical device submissions.

Key submission requirements include a clear description of the intended use and indications for each ultrasound system and transducer, as well as detailed clinical measurement accuracy information. Applicants must describe the methodology used to validate performance and specify accuracy ranges for each transducer and imaging mode. The notice also emphasizes the importance of re use instructions, including validated cleaning, disinfection, and sterilization processes, and the use of licensed sterile transducer sheaths where applicable.

A major focus of the notice is acoustic output requirements, using terminology from IEC 60601 2 37, such as Thermal Index (TI), Mechanical Index (MI), and acoustic intensity parameters. Separate limits are provided for systems that comply with the Output Display Standard and for those that do not. For compliant systems, upper limits are defined for parameters such as ISPTA.3 and MI, with significantly lower thresholds for ophthalmic applications.

For non compliant systems, the notice specifies global maximum derated output limits by clinical use category, including peripheral vessel, cardiac, fetal and other imaging, and ophthalmic use. Ophthalmic applications are subject to the strictest limits due to higher sensitivity to ultrasound exposure. The notice also clarifies how different clinical applications are categorized to ensure correct application of the limits.