{"id":35377,"date":"2026-02-26T14:11:48","date_gmt":"2026-02-26T13:11:48","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35377"},"modified":"2026-02-26T14:25:19","modified_gmt":"2026-02-26T13:25:19","slug":"mdsap-audit-approach-version-010-released-what-changes","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/","title":{"rendered":"MDSAP: Audit Approach Version 010 Released, what changes"},"content":{"rendered":"<p>On <strong>February 2, 2026<\/strong>, version 010 of the <strong>MDSAP AU P0002<\/strong> <strong>\u2013 Audit Approach<\/strong> 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.<\/p>\n<h3><strong>MDSAP and the Audit Approach: definition and structure<\/strong><\/h3>\n<p>It is essential for manufacturers to distinguish between the program itself and the operational tool that governs it:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/2019\/08\/23\/what-about-the-mdsap\/\"><strong>MDSAP<\/strong><\/a><strong> (Medical Device Single Audit Program):<\/strong> the program that allows a single audit to satisfy the Quality Management System (QMS) requirements of the five participating jurisdictions.<\/li>\n<li><a href=\"https:\/\/www.mdsap.global\/documents\/library\/audit-approach\"><strong>Audit Approach (AU P0002):<\/strong><\/a> the operational manual used by auditors to conduct the inspection. This document is built on a rigorous structure designed to ensure that <strong>Country-specific requirements<\/strong> are correctly integrated during the audit process.<\/li>\n<\/ul>\n<h3><strong>Audit: 7 Key Processes<\/strong><\/h3>\n<p>The Audit Approach guides the auditor through <strong>7 main processes<\/strong>, each subdivided into specific <strong>Tasks<\/strong> (verification objectives) that integrate ISO 13485 requirements with national (Country-specific) regulations.<\/p>\n<ol>\n<li><strong>Management:<\/strong> the core of the system. It comprises 11 tasks verifying Top Management commitment, resource availability, risk planning, and Quality Manual compliance.<\/li>\n<li><strong>Device Marketing Authorization and Facility Registration:<\/strong> verifies that the site and devices are properly registered with the competent national authorities. In Version 010, <strong>Tasks 1 and 2<\/strong> of this process integrate new ANVISA references and FDA obligations regarding device listing and PCCP plans.<\/li>\n<li><strong>Measurement, Analysis and Improvement:<\/strong> focused on CAPA, internal audits, and continuous improvement.<\/li>\n<li><strong>Medical Device Adverse Events and Advisory Notices Reporting<\/strong> verifies the management of vigilance and post-market reporting specific to each jurisdiction. Specifically, <strong>Tasks 4 and 5<\/strong> have been updated to incorporate the new Australian <strong>PRAC<\/strong> protocol.<\/li>\n<li><strong>Design and Development:<\/strong> rigorous control of the device design and development processes.<\/li>\n<li><strong>Production and Service Controls:<\/strong> verification of manufacturing processes, environmental controls, and related service delivery.<\/li>\n<li><strong>Purchasing:<\/strong> dedicated to the evaluation and control of suppliers and purchased products\/services. <strong>Tasks 3 and 4<\/strong> now reflect the transition away from the &#8220;critical supplier&#8221; concept in favor of a dynamic approach based on effective involvement within the audit scope.<\/li>\n<\/ol>\n<h3><strong>What\u2019s new in version 010<\/strong><\/h3>\n<p>The 2026 update introduces substantial changes that manufacturers must now reflect in their QMS:<\/p>\n<ul>\n<li><strong>Supplier Management:<\/strong> the term &#8220;critical supplier&#8221; has been removed and replaced with a more operational definition: <strong>&#8220;suppliers that should be considered for audit as part of the MDSAP audit of the organization.&#8221;<\/strong> This reflects a more dynamic approach to the supply chain.<\/li>\n<li><strong>Australia (TGA):<\/strong> the <em>Uniform Recall Procedure for Therapeutic Goods<\/em> (URPTG) has been officially replaced by the new <strong>PRAC<\/strong> protocol (<em>Procedure for recalls, product alerts and product corrections<\/em>).<\/li>\n<li><strong>United States (FDA):<\/strong> in this new version, all references and citations to the old <em>Quality System Regulation<\/em> (QSR) have been officially removed to align with the <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/02\/the-new-fda-qmsr-aligned-with-iso-13485-what-changes\/\"><strong>QMSR<\/strong><\/a>, which came into effect on February 2, 2026. Furthermore, the requirement to update <strong>device listing<\/strong> information between October 1 and December 31 has been incorporated. A specific section dedicated to <strong>PCCP<\/strong> <strong>(<em>Predetermined Change Control Plans<\/em>)<\/strong> has also been introduced, which is essential for managing changes in software and AI-based systems.<\/li>\n<li><strong>Brazil (ANVISA):<\/strong> updated regulatory references for the registration process:<\/li>\n<\/ul>\n<ul>\n<li><strong>RDC 830\/2023<\/strong> replaces the old RDC 36\/2015.<\/li>\n<li><strong>RDC 751\/2022<\/strong> replaces the old RDC 40\/2015.<\/li>\n<\/ul>\n<p><strong>&gt;&gt;&gt; Thema <\/strong>supports you in adapting your Quality Management System and ensuring full alignment with the new tasks of the MDSAP program.<\/p>\n<p><strong>SOURCE:<\/strong><br \/>\n<a href=\"https:\/\/www.mdsap.global\/documents\/library\/audit-approach\"><strong>Audit Approach | Medical Device Single Audit Program (MDSAP)<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On February 2, 2026, version 010 of the MDSAP AU P0002 \u2013 Audit Approach manual was released. This update comes nearly  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35372,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-35377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDSAP: Audit Approach Version 010 Released, what changes - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDSAP: Audit Approach Version 010 Released, what changes - Thema Med\" \/>\n<meta property=\"og:description\" content=\"On February 2, 2026, version 010 of the MDSAP AU P0002 \u2013 Audit Approach manual was released. 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