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By Jennifer Day
MDSAP, or the Medical Device Single Audit Program, stands as an acronym that resonates across the medical device
industry. But what exactly is MDSAP? It represents the Medical Device Single Audit Program, a pioneering international
endeavor. Th is program empowers medical device manufacturers to undergo a unifi ed regulatory audit that fulfi lls the
requirements of multiple regulatory authorities.
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MDSAP condenses the regulatory process by enabling manufacturers to satisfy the criteria of
multiple countries with just one audit, eliminating the need for individual audits in each nation.
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Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP unites regulatory authorities from
Australia, Brazil, Canada, Japan, and the United States. Its overarching objective is to harmonize and standardize the
regulatory landscape for medical devices across participating countries. Th is initiative signifi cantly diminishes the need for
redundant audits and assessments.
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Manufacturers can save time, resources, and costs associated with undergoing separate audits
and assessments from diverse regulatory authorities.
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Facilitating entry into major markets including Australia, Brazil, Canada, Japan, and the United
States, collectively representing a substantial segment of the global medical device market.
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MDSAP aligns regulatory requirements and audit protocols among participating countries, endorsing
a more uniform approach to compliance and quality management.