🇨🇦 Health Canada – ISO 13485 & MDSAP Compliance Guidance

🇨🇦 Health Canada – ISO 13485 & MDSAP Compliance Guidance

Health Canada QMS Requirements:

Health Canada requires all manufacturers of Class II, III, and IV medical devices, whether holding existing licences or applying for new or amended licences, to implement and comply with ISO 13485:2016. As part of this requirement, manufacturers must submit a valid ISO 13485:2016 certificate to Health Canada. Importantly, Health Canada will only accept ISO 13485 certificates issued under the Medical Device Single Audit Program (MDSAP).

Core Requirement

  • ISO 13485:2016 Compliance: All manufacturers of Class II, III, and IV medical devices must implement and maintain a QMS certified to ISO 13485:2016.
  • Certificate Submission: A valid ISO 13485:2016 certificate must be submitted to Health Canada when applying for new, amended, or renewed licences.
  • MDSAP Mandate: Health Canada accepts only ISO 13485 certificates issued under the Medical Device Single Audit Program (MDSAP)


 What is MDSAP?

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF). It allows a single audit to satisfy QMS requirements for multiple jurisdictions, including:

  • Health Canada
  • U.S. FDA
  • European Union (limited scope)
  • Japan’s PMDA/MHLW
  • Australia’s TGA
  • Brazil’s ANVISA

This harmonized approach reduces duplication and ensures consistent global compliance.


What MDSAP Audits Cover

MDSAP audits go beyond ISO 13485:2016 by including:

  • Regulatory requirements specific to Canada under the Food and Drugs Act and Medical Devices Regulations (SOR/98-282).
  • Complaint handling and mandatory problem reporting procedures.
  • Distribution recordkeeping to enable rapid recalls.
  • Post-market surveillance obligations such as adverse event reporting.
  • Risk management integration aligned with ISO 14971.


Risks of Non-Compliance

  • Licence Refusal or Suspension: Without a valid MDSAP certificate, Health Canada will not issue or renew a medical device licence.
  • Market Access Delays: Non-compliance can delay product launches or imports.


How We Support You

Our services ensure smooth compliance with Health Canada’s requirements:

  • Guidance on ISO 13485:2016 implementation and integration into your QMS.
  • Preparation for MDSAP audits, including gap analysis .
  • Assistance with licence applications and renewals for Class II-IV devices.
  • Ongoing compliance support for distribution records, complaint handling, and mandatory reporting.
  • Strategic advice to align Canadian requirements with your global regulatory strategy.


In summary:

Health Canada’s mandate for ISO 13485 certification under MDSAP ensures that manufacturers meet both international quality standards and Canadian-specific regulatory obligations. By preparing thoroughly and leveraging expert guidance, companies can secure licences, maintain compliance, and achieve faster, safer market access.