The Medical Device Single Audit Program (MDSAP) authorities have released updated versions of several key documents, including the MDSAP Audit Approach, Audit Report Form, and Nonconformity Grading and Exchange (NGE) Form. These updates are effective immediately and reflect changes in global medical device regulations and aim to facilitate consistent, effective audits across participating countries. Manufacturers should review these changes carefully and assess whether updates to their management systems or audit preparation processes are necessary to maintain compliance.

Changes to MDSAP Audit Approach

The MDSAP Audit Approach document guides how audits are performed under the program. The latest version introduces several notable changes:

• • Supplier Terminology Update: On page 11, the term “critical supplier” has been replaced with “suppliers that should be considered for audit as part of the MDSAP audit of the organization.” This change broadens the focus to include all suppliers with potential impact on product quality.

• • Recall Procedure Reference: The reference to the TGA Uniform Recall Procedure for Therapeutic Goods (URPTG) has been replaced with the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. PRAC outlines updated processes for managing recalls and product safety actions in Australia.

• • FDA Quality System Regulation References Removed: All references and citations to the FDA Quality System Regulation (QSR) have been removed throughout the document, reflecting the adoption of the new QMSR.

• • Device Marketing Authorization and Facility Registration Updates:

• • ANVISA Regulatory References: Brazilian regulatory requirements now cite ANVISA RDC nº 36/2015 as RDC nº 830/2023 and RDC nº 40/2015 as RDC nº 751/2022. RDC (Resolução da Diretoria Colegiada) are resolutions set by ANVISA, Brazil’s Health Regulatory Agency, which define regulatory obligations for medical devices.

• • FDA Device Listing Updates: The FDA now requires device listing information to be updated between October 1 and December 31 each year, or as changes occur, at the manufacturer’s discretion.

• • Introduction of PCCP: Information on Predetermined Change Control Plans (PCCP) has been added. A PCCP is a regulatory document that medical device manufacturers—especially for devices with artificial intelligence or machine learning (AI/ML) capabilities—submit to outline planned future modifications (such as algorithm updates) and the procedures for implementing them. PCCPs allow manufacturers to make validated, pre-approved changes to products without submitting new marketing applications (e.g., 510(k)) for each update.

These changes align the audit process with evolving global regulatory requirements and clarify expectations for manufacturers operating in multiple jurisdictions.

Transition to Other MDSAP Document Updates

In addition to the changes in the audit approach, the MDSAP authorities have updated other core documents to ensure consistency and regulatory alignment. The following sections summarize the key modifications to each.

Updates to MDSAP Report Form

Updates to Non-conformity Grading and Exchange (NGE) Form

Contact us for assistance with integrating these requirements into your management system.