On February 2, 2026, version 010 of the MDSAP AU P0002 – Audit Approach manual was released. This update comes nearly 18 months after the previous version (009, August 2024) and reflects the regulatory transformations within the participating member states: Australia, Brazil, Canada, Japan, and the United States.

MDSAP and the Audit Approach: definition and structure

It is essential for manufacturers to distinguish between the program itself and the operational tool that governs it:

  • MDSAP (Medical Device Single Audit Program): the program that allows a single audit to satisfy the Quality Management System (QMS) requirements of the five participating jurisdictions.
  • Audit Approach (AU P0002): the operational manual used by auditors to conduct the inspection. This document is built on a rigorous structure designed to ensure that Country-specific requirements are correctly integrated during the audit process.

Audit: 7 Key Processes

The Audit Approach guides the auditor through 7 main processes, each subdivided into specific Tasks (verification objectives) that integrate ISO 13485:2016 requirements with national (Country-specific) regulations.

  1. Management: the core of the system. It comprises 11 tasks verifying Top Management commitment, resource availability, risk planning, and Quality Manual compliance.
  2. Device Marketing Authorization and Facility Registration: verifies that the site and devices are properly registered with the competent national authorities. In Version 010, Tasks 1 and 2 of this process integrate new ANVISA references and FDA obligations regarding device listing and PCCP plans.
  3. Measurement, Analysis and Improvement: focused on CAPA, internal audits, and continuous improvement.
  4. Medical Device Adverse Events and Advisory Notices Reporting verifies the management of vigilance and post-market reporting specific to each jurisdiction. Specifically, Tasks 4 and 5 have been updated to incorporate the new Australian PRAC protocol.
  5. Design and Development: rigorous control of the device design and development processes.
  6. Production and Service Controls: verification of manufacturing processes, environmental controls, and related service delivery.
  7. Purchasing: dedicated to the evaluation and control of suppliers and purchased products/services. Tasks 3 and 4 now reflect the transition away from the “critical supplier” concept in favor of a dynamic approach based on effective involvement within the audit scope.

What’s new in version 010

The 2026 update introduces substantial changes that manufacturers must now reflect in their QMS:

  • Supplier Management: the term “critical supplier” has been removed and replaced with a more operational definition: “suppliers that should be considered for audit as part of the MDSAP audit of the organization.” This reflects a more dynamic approach to the supply chain.
  • Australia (TGA): the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been officially replaced by the new PRAC protocol (Procedure for recalls, product alerts and product corrections).
  • United States (FDA): in this new version, all references and citations to the old Quality System Regulation (QSR) have been officially removed to align with the QMSR, which came into effect on February 2, 2026. Furthermore, the requirement to update device listing information between October 1 and December 31 has been incorporated. A specific section dedicated to PCCP (Predetermined Change Control Plans) has also been introduced, which is essential for managing changes in software and AI-based systems.
  • Brazil (ANVISA): updated regulatory references for the registration process:
  • RDC 830/2023 replaces the old RDC 36/2015.
  • RDC 751/2022 replaces the old RDC 40/2015.

>>> Thema supports you in adapting your Quality Management System and ensuring full alignment with the new tasks of the MDSAP program.

SOURCE:
Audit Approach | Medical Device Single Audit Program (MDSAP)