--- title: "MDSAP, Medical Device Single Audit Program | MedTech Terms" description: "Single audit of a manufacturer's QMS satisfying multiple participating regulators. Plain-English Quality & Risk definition for MedTech teams, with examples and" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdsap#term", "name": "Medical Device Single Audit Program", "alternateName": "MDSAP", "description": "MDSAP allows a single regulatory audit of a medical device manufacturer's QMS that satisfies the requirements of multiple participating regulatory authorities, including the U.S. FDA, Health Canada, ANVISA, TGA, and PMDA.", "url": "https://medtechterms.com/terms/mdsap", "termCode": "mdsap", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/mdsap#article", "headline": "MDSAP, Medical Device Single Audit Program", "description": "Single audit of a manufacturer's QMS satisfying multiple participating regulators.", "url": "https://medtechterms.com/terms/mdsap", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/mdsap" }, "about": { "@id": "https://medtechterms.com/terms/mdsap#term" }, "articleSection": "Quality & Risk", "inLanguage": "en", "keywords": "Medical Device Single Audit Program, MDSAP, Quality & Risk, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA MDSAP", "url": "https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "MDSAP Audit Approach & Companion Document", "url": "https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-approach", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "MDIC Case for Quality", "url": "https://mdic.org/program/case-for-quality/", "publisher": { "@type": "Organization", "name": "MDIC" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-13485#term", "name": "ISO 13485", "url": "https://medtechterms.com/terms/iso-13485" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/qmsr#term", "name": "Quality Management System Regulation", "alternateName": "QMSR", "url": "https://medtechterms.com/terms/qmsr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/qsr#term", "name": "Quality System Regulation", "alternateName": "QSR / 21 CFR 820", "url": "https://medtechterms.com/terms/qsr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/capa#term", "name": "Corrective and Preventive Action", "alternateName": "CAPA", "url": "https://medtechterms.com/terms/capa" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Quality & Risk", "item": "https://medtechterms.com/terms?cat=Quality%20%26%20Risk" }, { "@type": "ListItem", "position": 4, "name": "Medical Device Single Audit Program", "item": "https://medtechterms.com/terms/mdsap" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/mdsap#faq", "mainEntity": [ { "@type": "Question", "name": "Which countries participate in MDSAP?", "acceptedAnswer": { "@type": "Answer", "text": "The five regulatory authorities are the US FDA, Health Canada, Brazil ANVISA, Australia TGA, and Japan MHLW/PMDA. 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MDSAP audit reports may inform Notified Body assessments but do not replace them. Some manufacturers combine MDSAP and Notified Body audits to reduce duplication." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Medical Device Single Audit Program [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets)MDSAP # Medical Device Single Audit Program Single audit of a manufacturer's QMS satisfying multiple participating regulators. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition MDSAP allows a single regulatory audit of a medical device manufacturer's QMS that satisfies the requirements of multiple participating regulatory authorities, including the U.S. FDA, Health Canada, [ANVISA](/terms/anvisa), [TGA](/terms/tga), and [PMDA](/terms/pmda). What the regulation says The Medical Device Single Audit Program (MDSAP) is a program allowing a single audit of a medical device manufacturer’s quality management system (QMS) to satisfy the regulatory requirements of multiple participating authorities. The U.S. FDA accepts MDSAP audit reports as a substitute for routine surveillance inspections, as noted in their guidance documents. Health Canada mandates MDSAP certification for medical device licensing, as specified in their Medical Devices Regulations (SOR/98-282), Section 43.1. Other participating regulatory authorities include Brazil’s [ANVISA](/terms/anvisa), Australia’s [TGA](/terms/tga), and Japan’s [PMDA](/terms/pmda), all of whom utilize MDSAP audit outcomes for their regulatory oversight. ## What this means in practice MDSAP was developed by [IMDRF](/terms/imdrf) and operationalized by the five participating regulators: US FDA, Health Canada, Brazil [ANVISA](/terms/anvisa), Australia [TGA](/terms/tga), and Japan MHLW/ [PMDA](/terms/pmda). Health Canada requires MDSAP for medical device licensure (mandatory since 2019). FDA accepts MDSAP audit reports in lieu of routine surveillance inspections (though for-cause and pre-approval inspections still occur). Audits are conducted by MDSAP-authorized Auditing Organizations against [ISO 13485](/terms/iso-13485):2016 plus country-specific requirements documented in the MDSAP Audit Model. Audit duration is calculated from a formula in the MDSAP Companion Document based on employee count and site complexity. ## Examples - A mid-size Class II manufacturer replacing separate FDA, Health Canada, and TGA audits with a single MDSAP audit cycle, saving roughly 15 audit-days per year. - A contract manufacturer maintaining MDSAP certification to demonstrate to customers that its QMS satisfies five major regulators without additional audits. Common pitfalls - • Assuming MDSAP replaces all FDA inspections. Pre-approval, for-cause, and Bioresearch Monitoring inspections are outside the MDSAP scope. - • Under-scoping. MDSAP scope must cover all sites and processes relevant to devices marketed in participating countries; missed scope triggers gaps at surveillance audits. - • Poor preparation for country-specific requirements. Each regulator layers requirements (e.g. Brazil GMP, Japan JPAL) on top of ISO 13485 that are frequently missed. - • Treating the initial certification audit as a one-off. MDSAP requires annual surveillance audits and a three-year recertification cycle with sample-based coverage. ## Frequently asked questions Which countries participate in MDSAP? The five regulatory authorities are the US FDA, Health Canada, Brazil [ANVISA](/terms/anvisa), Australia [TGA](/terms/tga), and Japan MHLW/ [PMDA](/terms/pmda). WHO Prequalification and EU Notified Bodies participate as observers but are not full members. Is MDSAP mandatory? How long does an MDSAP audit take? Does MDSAP satisfy EU MDR requirements? ## Cross-references ### Used by Things that build on this term. - [ Health Canada Medical Device Licence(MDL) ](/terms/health-canada-mdl) - [ ANVISA(ANVISA) ](/terms/anvisa) - [ Therapeutic Goods Administration(TGA) ](/terms/tga) - [ Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 FDA· 2 MDIC· 1 1. [1 FDA MDSAP Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap) 2. [2 MDSAP Audit Approach & Companion Document Unchecked FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-approach) 3. [3 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Acronym MDSAP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mdsap) Learn in 60 seconds Card Lesson Quiz Single audit of a manufacturer's QMS satisfying multiple participating regulators. - · MDSAP was developed by IMDRF and operationalized by the five participating regulators: US FDA, Health Canada, Brazil ANVISA, Australia TGA, and Japan MHLW/PMDA. - · Health Canada requires MDSAP for medical device licensure (mandatory since 2019). - · FDA accepts MDSAP audit reports in lieu of routine surveillance inspections (though for-cause and pre-approval inspections still occur). Remember this Watch out: Assuming MDSAP replaces all FDA inspections. Pre-approval, for-cause, and Bioresearch Monitoring inspections are outside the MDSAP scope. Related terms - [ISO 13485 ](/terms/iso-13485) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Corrective and Preventive Action(CAPA) ](/terms/capa) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Internal Audit ](/terms/internal-audit) - [IMDRF Principles and Practices for Medical Device Cybersecurity ](/terms/imdrf-cyber-principles) - [Trial Master File(TMF) ](/terms/trial-master-file) - [Device Master File(MAF) ](/terms/device-master-file) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [ISO 20417 ](/terms/iso-20417) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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