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January 5, 2026
Approximately 5 minutes
Interim Guidance on Importing and Manufacturing Medical Gowns During COVID-19 – Health Canada
Interim Guidance on Importing and Manufacturing Medical Gowns During COVID-19 – Health Canada
Context and Purpose
During the early stages of the COVID-19 pandemic, Canada faced significant shortages of personal protective equipment (PPE), including medical gowns (isolation gowns). To help ensure continued supply to healthcare settings, Health Canada issued interim guidance allowing greater flexibility in importation and manufacturing while upholding essential safety and performance requirements. The guidance applied to isolation gowns intended for healthcare use and was time-limited to the period of heightened demand. Source: Interim Guidance on Importing and Manufacturing Medical Gowns - Canada.ca
Scope and Device Classification
- Medical gowns (isolation gowns) are classified as Class I medical devices in Canada when intended to protect healthcare workers and patients from transfer of microorganisms and body fluids in low- to moderate-risk situations.
- The guidance focused on non-sterile isolation gowns; sterile surgical gowns remained subject to stricter Class II requirements.
- Manufacturers and importers were encouraged to prioritize devices meeting recognized standards but were permitted alternatives under specific conditions.
Flexible Regulatory Pathways
Acceptance of Alternative Standards
- Gowns meeting international consensus standards (e.g., ANSI/AAMI PB70, EN 13795, GB 19082) were prioritized.
- In shortage situations, gowns meeting lower levels of protection or alternative test methods could be considered if supported by risk assessment and justification.
- Non-traditional suppliers (e.g., textile manufacturers) were allowed to produce gowns if they could demonstrate equivalent performance through testing or engineering rationale.
Labelling and Claims Flexibilities
- Temporary allowances for bilingual labelling (English/French) to be provided post-import in some cases.
- Claims such as “Level 1–4 protection” permitted when aligned with recognized standards.
- Instructions for use could be provided electronically or via simplified formats during shortages.
Importation and Authorization Options
- Importers could use the Interim Order process or expedited review pathways for emergency use.
- Foreign manufacturers with existing authorizations in comparable jurisdictions (e.g., FDA EUA, EU CE mark) could leverage reliance pathways.
- Post-market surveillance requirements remained in place, including mandatory problem reporting.
Manufacturing Considerations
- Manufacturers were expected to maintain quality management systems appropriate to Class I devices.
- Validation of barrier performance, fluid resistance, and strength testing was required even under flexible pathways.
- Risk management files documenting deviations from standard requirements were essential.
Risk-Based Oversight and Transition
- Health Canada applied a risk-based approach: higher scrutiny for gowns intended for higher-risk procedures.
- Temporary authorizations were reviewed periodically and tied to supply-demand status.
- As shortages eased, manufacturers were required to transition to full compliance with standard requirements.
This interim guidance played a critical role in maintaining PPE availability during the peak of the COVID-19 response in Canada. Detailed requirements, acceptable standards lists, submission templates, and transition expectations are provided in the official Health Canada interim guidance on medical gowns during COVID-19. Source: Interim Guidance on Importing and Manufacturing Medical Gowns - Canada.ca
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