MDSAP: Multi-Country Audit Efficiency for Turkish Exporters
What Is MDSAP?
MDSAP (Medical Device Single Audit Programme) is a joint initiative of health authorities from five countries — Canada (Health Canada), USA (FDA), Brazil (ANVISA), Japan (MHLW/PMDA), and Australia (TGA) — that allows a single quality management system audit conducted by an MDSAP-authorised auditing organisation to satisfy the QMS audit requirements of all five participating countries simultaneously.
MDSAP was formally launched in 2019. Canada mandates MDSAP for all Class II, III, and IV medical device manufacturers selling in Canada (with a few exceptions). The USA, Brazil, Japan, and Australia accept MDSAP audit reports in lieu of their own facility inspections.
Part 02Which Countries Accept MDSAP
| Country | MDSAP Status | Requirement Level |
|---|---|---|
| Canada (Health Canada) | Mandatory since 2019 | Required for Class II/III/IV MDL |
| USA (FDA) | Accepted (voluntary) | FDA accepts MDSAP in lieu of routine inspection |
| Brazil (ANVISA) | Accepted | MDSAP report accepted for GMP audit |
| Japan (MHLW/PMDA) | Accepted | MDSAP accepted as QMS audit evidence for PMDA review |
| Australia (TGA) | Accepted | TGA accepts MDSAP in lieu of TGA facility audit |
| EU/UK | Not a participant | ISO 13485 NB audit required separately |
MDSAP Audit Structure
An MDSAP audit is structured around seven process categories that cover the full ISO 13485 QMS scope, mapped to the specific regulatory requirements of each participating country:
- Management
- Device Marketing Authorisation and Facility Registration
- Measurement, Analysis and Improvement
- Design and Development
- Production and Service Controls
- Purchasing
- Customer-Related Processes
The audit is conducted by an MDSAP-authorised auditing organisation (AO) — not a government inspector. Currently authorised AOs include BSI, SGS, DNV, TÜV SÜD, and several others. The AO submits the audit report to each participating country's authority. Countries review the report and take regulatory action (inspection, information request) only if significant findings are identified.
Part 04MDSAP vs Standard ISO 13485 Certification — Cost Comparison
| Scenario | Annual Audit Cost | Countries Covered |
|---|---|---|
| ISO 13485 (EU NB only) | EUR 8,000–15,000/year | EU/UK markets |
| ISO 13485 + Health Canada audit | EUR 8,000–15,000 + CAD 15,000–25,000 | EU + Canada |
| ISO 13485 + Health Canada + TGA audit | EUR 8,000–15,000 + CAD 15,000–25,000 + AUD 8,000–15,000 | EU + Canada + Australia |
| ISO 13485 + MDSAP (combined) | EUR 20,000–35,000/year total | EU + Canada + USA + Brazil + Japan + Australia |
MDSAP typically adds EUR 8,000–20,000 per year over a standard ISO 13485 audit — but replaces separate national audit requirements for five countries. The break-even is typically at 2 markets beyond EU; for companies targeting 3+ MDSAP countries, it delivers significant cost savings.
Part 05Is MDSAP Right for Your Company?
MDSAP makes strategic sense for Turkish manufacturers who:
- Have active sales or serious market entry plans in Canada — where MDSAP is mandatory for Class II/III/IV devices
- Are pursuing FDA registration (510(k) or PMA) — MDSAP significantly reduces FDA inspection risk during the clearance process and post-market
- Target Brazil — ANVISA GMP audit is one of the most demanding in Latin America; MDSAP acceptance streamlines Brazilian market access
- Have existing ISO 13485 certification and a QMS mature enough to pass a multi-country requirements audit — MDSAP is not a starting point for QMS development
MDSAP does NOT replace EU MDR Notified Body audits — EU/UK remain outside the programme. For companies whose primary focus is the EU market with limited multi-country plans, MDSAP may not yet be the priority investment.
Part 06How to Achieve MDSAP Certification
- Step 1 — Gap assessment: Conduct an MDSAP gap assessment against your existing ISO 13485 QMS — identify which country-specific requirements (Canada, USA, Brazil, Japan, Australia) are not currently covered
- Step 2 — QMS upgrade: Implement required additional procedures (particularly Canada-specific and Brazil-specific regulatory requirement procedures)
- Step 3 — Select an MDSAP AO: BSI, SGS, and TÜV SÜD are the most commonly used by Turkish manufacturers; compare pricing and language capability
- Step 4 — Initial MDSAP audit: First audit covers full QMS review — typically 3–5 audit days on-site
- Step 5 — Registration and reporting: AO submits audit report to all participating country authorities; certificates issued within 30–60 days of successful audit
- Step 6 — Surveillance: Annual surveillance audits (2–3 days) maintain certification; full recertification every 3 years