What Is the Medical Device Single Audit Program (MDSAP) and Why It Matters

For companies in the medical device space, compliance isn't just a checkbox—it’s the gateway to global markets. But keeping up with audits from multiple regulatory bodies can quickly turn into a logistical nightmare.

The Medical Device Single Audit Program (MDSAP) was created to fix that.

MDSAP allows a single, standardized audit to satisfy the requirements of multiple countries: the U.S. (FDA), Canada (Health Canada), Japan (MHLW/PMDA), Brazil (ANVISA), and Australia (TGA). So instead of preparing for five separate audits, you can knock them all out at once.

Why MDSAP Is a Game-Changer

Here’s why so many manufacturers are making the shift:

• ✅ One audit, global access
• ✅ Fewer disruptions to business operations
• ✅ Better alignment with international standards
• ✅ Greater confidence in your quality management system

With MDSAP, companies not only save time and resources but also gain a stronger foundation for long-term regulatory success.

How the Audit Works

The audit is performed by a certified Auditing Organization (AO), recognized by all participating regulators. It’s based primarily on ISO 13485:2016 and tailored with each country's unique requirements. The audit digs into your processes, from design and manufacturing to post-market surveillance.

Need Help Preparing?

Going through your first MDSAP audit can feel overwhelming—but you don’t have to do it alone. Advena Medical offers expert guidance, helping manufacturers get MDSAP-ready with confidence. Their team walks you through every step—from gap analysis to audit support—ensuring your quality system is robust and compliant.

Final Thoughts

If you’re serious about expanding globally and want to simplify compliance, MDSAP is more than a regulatory checkbox—it’s a strategic advantage. And with the right partner by your side, the process becomes a whole lot smoother.