Industry & Export

MDSAP: Multi-Country Audit Efficiency for Turkish Exporters

Turkish Medical Index 22 October 2026 turkishmedicalindex.com 4 min read

At a glanceThe Medical Device Single Audit Programme (MDSAP) is one of the most powerful regulatory efficiency tools available to Turkish medical device manufacturers — a single quality management system audit accepted by Canada, USA, Brazil, Japan, and Australia. For Turkish manufacturers targeting multiple international markets, MDSAP replaces five separate national audits with one, dramatically reducing audit burden, travel costs, and QMS disruption. This guide explains how MDSAP works, what it costs, and whether it makes strategic sense for your company.

Part 01

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 02

Which 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

Part 03

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 04

MDSAP 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 05

Is 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 06

How 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

MDSAP is the most efficient regulatory investment available to Turkish medical device manufacturers targeting North America, Latin America (Brazil), Japan, or Australia alongside their EU business. A single audit framework covering six major markets reduces QMS disruption, audit cost, and regulatory relationship management burden. For Turkish manufacturers with active Canada or US market entry plans, MDSAP is not optional — Health Canada mandates it for Class II/III/IV devices. For those with Japan or Australia ambitions, MDSAP acceptance materially simplifies what would otherwise be complex separate national audit requirements.

MDSAP: Medical Device Single Audit Programme Guide for Turkish Manufacturers