MDSAP Single Audit Approach

What is MDSAP Single Audit Program?

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single QMS audit for multiple regulatory jurisdictions.

Who participates at the Medical Device Single Audit Program?

Australia, Brazil, Canada, Japan and the United States.

International Coverage = international Market Access

What is the single Audit approach document?

Audit Approach MDSAP AU, Version P0002.007

This particular document is the summary of all national requirements and ISO 13485 requirements for a quality management system. ColabON has spend a lot of time digizine this document. It consists of very helpful information.

And ColabON has added a helpful title numbering and structure. With the help of an experienced auditor. Thank you.

The following titles appear serval times in the very long document.

Audit Tasks

Use this guideline to plan and perform internal audits!

Clause and Regulation

This chapter includes the references to

International Standard Organization ISO

• clauses of ISO 13485

Australia (TGA)

• Therapeutic Goods (Medical Devices) Regulations 2002

Brazil (ANVISA)

• Brazilian Health Surveillance Agency
• Resolution RDC 16 2013
• Resolution RDC 23 2012
• Resolution RDC 67 2009

Canada: HC (Health Canada)

• Medical Devices Regulations (SOR/98-282)

Japan (MHLW)

• Japanese Medical Device QMS Requirements and other related Regulatory Informatio

USA: FDA (Food and Drug Administration)

• 21 CFR 803 MEDICAL DEVICE REPORTING
• 21CFR806–Subchapter H–Medical Devices–Part 806 Medical Devices; Reports of Corrections and Removals
• 21 CFR 807 – ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
• 21 CFR 820 – QUALITY SYSTEM REGULATION
• 21 CFR 821 – MEDICAL DEVICE TRACKING REQUIREMENTS

Additional Country Specific requirements

Other MDSAP Documents:

This There is helpful QMS guideline on the FDA homepage: List of MDSAP documents.

MDSAP AU P0002.007 Table of Contents:

Note: ColabON has added the Chapter Numbering.

Why? Because the underlying task numbering is better to understand.

1. C1.001 Chapter 1 – Management
2. C2.001 Chapter 2 – Device Marketing Authorization and Facility Registration
3. C3.001 Chapter 3 – Measurement, Analysis and Improvement
4. C4.001 Chapter 4 – Medical Device Adverse Events and Advisory Notices Reporting
5. C5.001 Chapter 5 – Design and Development
6. C6.001 Chapter 6 – Production and Service Controls
7. C7.001 Chapter 7 – Purchasing
8. A1 Annex 1 – Audit of Product/Process related Technologies and Technical Documentation
9. A2 Annex 2 – Audit of Requirements for Sterile Medical Devices
10. A3 Annex 3 – Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference
11. A4 Annex 4 – Requirements for Written Agreements
12. A5 Annex 5 – Japan’s QMS Ordinance Revision – Tables
13. A6 Annex 6 – Acceptable exclusions from an organization’s scope of certification
14. A6 Summary of Changes from Prior Revisions