MDSAP In Depth
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is an international audit program that allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of five regulatory jurisdictions:
| Jurisdiction | Regulatory authority |
|---|---|
| 🇨🇦 Canada | Health Canada |
| 🇺🇸 United States | FDA |
| 🇦🇺 Australia | TGA |
| 🇧🇷 Brazil | ANVISA |
| 🇯🇵 Japan | PMDA |
A single MDSAP audit certificate satisfies all five jurisdictions' QMS audit requirements, eliminating the need for multiple separate audits.
Why MDSAP matters for Canada
Health Canada requires a current MDSAP audit certificate (or equivalent) as part of Device Licence applications for Class II, III, and IV devices. An ISO 13485 certificate from an accredited certification body is no longer sufficient on its own for Health Canada submissions.
MDSAP audit structure
The MDSAP audit covers the manufacturer's QMS against:
- ISO 13485:2016 (the QMS standard)
- Regulatory requirements of each participating jurisdiction
MDSAP audits are conducted by accredited Auditing Organizations (AOs) — third-party certification bodies accredited by the relevant IAF-recognised accreditation body to conduct MDSAP audits.
MDSAP audit cycle
MDSAP audits follow a 3-year cycle:
- Year 1 — Full System Audit (FSA): comprehensive audit of all QMS processes
- Year 2 — Surveillance Audit 1 (SA1): focused audit of selected processes
- Year 3 — Surveillance Audit 2 (SA2): focused audit of remaining processes + renewal preparation
At the end of Year 3, a new FSA resets the cycle.
Obtaining an MDSAP certificate
- Select an accredited MDSAP Auditing Organization (list at imdrf.org/mdsap)
- Submit your quality manual and site information to the AO
- Schedule the audit
- Conduct the audit and address any non-conformances
- Receive your MDSAP audit report and certificate
MDSAP audit report vs. certificate
- The MDSAP Audit Report details the findings and non-conformances
- The MDSAP Audit Certificate confirms the QMS meets requirements and is valid for the audit cycle period
Health Canada requires submission of both the MDSAP Certificate and the MDSAP Audit Report Summary (or equivalent documentation) in Device Licence applications.
Non-conformances
MDSAP non-conformances are graded:
- Grade 1 (Major) — systemic failure to meet a critical requirement
- Grade 2 (Minor) — isolated failure or weakness
- Grade 3 (Opportunity for Improvement) — informational
Major non-conformances must be resolved before the certificate can be issued. Unresolved major non-conformances are reported to the regulatory authorities.