{"id":579,"date":"2021-06-16T08:57:35","date_gmt":"2021-06-16T08:57:35","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=579"},"modified":"2026-03-25T20:07:53","modified_gmt":"2026-03-25T20:07:53","slug":"medical-device-single-audit-program-mdsap","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/medical-device-single-audit-program-mdsap\/","title":{"rendered":"Medical Device Single Audit Program (MDSAP)"},"content":{"rendered":"\n
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The Medical Device Single Audit Program is a global approach to auditing and monitoring the manufacturing of medical devices. This program, launched in January  2014 like a Pilot Program with the participation of Health Authorities from Brazil, Australia, Canada, US and Japan, have the mission of \u201cstrategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety.<\/p>\n<\/div>\n<\/div><\/section>\n\n\n\n

In 2019 the category of MDSAP Affiliate Member was created: \u201cA non-participating MDSAP Observer or non-participating MDSAP RAC regulatory authority that wants to engage in MDSAP, demonstrates understanding of MDSAP and utilize MDSAP audit reports and\/or MDSAP certificates for evaluating a medical device manufacturer\u2019s quality management system.\u201d<\/p>\n\n\n\n

The MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices. The MDSAP allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.<\/p>\n\n\n\n

Nowadays, it is composed by:<\/p>\n\n\n\n

MDSAP Members<\/h2>\n\n\n\n
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<\/path><\/svg><\/span>Therapeutic Goods Administration of Australia<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Brazil\u2019s Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Health Canada<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Japan\u2019s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>U.S. Food and Drug Administration<\/span><\/div>\n<\/div><\/div>\n\n\n\n

MDSAP Official Observers<\/h2>\n\n\n\n
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<\/path><\/svg><\/span>European Union (EU)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Singapore\u2019s Health Sciences Authority (HSA)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency ( MHRA)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme<\/span><\/div>\n<\/div><\/div>\n\n\n\n

MDSAP Affiliate Members<\/h2>\n\n\n\n
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<\/path><\/svg><\/span>Argentina\u2019s National Administration of Drugs, Foods and Medical Devices (ANMAT)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Israel\u2019s Ministry of Health<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Kenya\u2019s Pharmacy and Poisons Board<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Republic of Korea\u2019s Ministry of Food and Drug Safety<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Mexico\u2019s Federal Commission for Protection from Sanitary Risks (COFEPRIS)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Taiwan\u2019s Food and Drug Administration (TFDA)<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>South African Health Products Regulatory Authority<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Malaysia\u2019s Medical Device Auhtority<\/span><\/div>\n<\/div><\/div>\n\n\n\n

More information about MDSAP Program can be found here<\/a>.<\/p>\n\n\n\n

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REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n