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Quick Guide: Compliance Intelligence MDSAP Framework

Written by Matus
Updated yesterday

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows a single audit to meet quality management system requirements for multiple regulatory authorities.

Participating Countries

  • United States (FDA)

  • Canada (Health Canada)

  • Brazil (ANVISA)

  • Australia (TGA)

  • Japan (MHLW/PMDA)

Note: Not all country requirements apply to every organization.

How the Framework Works

The Compliance Intelligence MDSAP framework is structured around key audit processes:

  • Management

  • Measurement, Analysis, and Improvement

  • Design and Development

  • Production and Service Controls

  • Purchasing

  • Device Marketing Authorization and Registration

Each process includes:

  • Global requirements → apply to all

    • Global requirements are identified with numbers, for example, 1.1 QMS Structure, see the image below.

  • Country-specific requirements → apply only if relevant

    • Country-specific requirements are identified with an abbreviation, for example, FDA-2.1.5, see the image below.

Applicability: The Key Concept

Only the requirements for countries where you operate or market devices apply to you.

Example

If you have only in the U.S. and Canada:

  • ✅ U.S. & Canada requirements apply

  • ❌ Brazil, Japan, and Australia can be excluded

When to Opt Out of Country Sections

Opt Out If:

  • You do not sell or distribute in that country

  • You have no regulatory approval there

  • You have no near-term plans to enter the market

  • Your product is not registered in that country

  • Select from the dropdown menu ‘Not applicable’.

  • You can add a justification for why it is not applicable.

  • After adding the justification, you can view that the specific requirement is not applicable.

When NOT to Opt Out

Do NOT Opt Out If:

  • You actively sell in that country

  • You have regulatory approvals or licenses

  • You plan to enter the market soon

  • Part of your operations is subject to that country’s regulations

Why It Matters?

Opting out helps you:

  • Focus only on relevant requirements

  • Reduce complexity

  • Improve audit readiness

  • Streamline compliance efforts

Note: You can re-include countries anytime as your business expands.

How to Use the Framework

  1. Identify your active markets

  2. Select applicable countries

  3. Opt out of non-relevant countries

  4. Review and update regularly

Walkthrough Video

Watch the video below for a step-by-step demonstration of configuring country applicability and using the framework. https://www.loom.com/share/c87146ae3ace4713ad522a390bac2445

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