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    MDSAP - Two scientists working in a laboratory
    Regulatory Services

    Medical Device Single Audit Program (MDSAP)

    What is a Medical Device Single Audit Program audit?

    Through MDSAP, medical device manufacturers need only to be audited once in order to comply with the standard and regulatory requirements of up to five different medical device markets.

    These are; Autralia, Brazil, Canada, Japan and United States. Audits are conducted by Auditing Organizations (AO), such as BSI, and authorized by MDSAP member Regulatory Authorities (RA). BSI is an Auditing Organization for MDSAP. Here at BSI, we also offer MDSAP in combination with CE, UKCA, ISO 13485 and ISO 9001 assessments. We have been active since MDSAP's inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs.

    MDSAP is based on a three-year audit cycle

    Initial Audit: The Initial Certification Audit is a complete audit of a medical device manufacturers Quality Management System (QMS).

    • Surveillance Audit - Year One.
    • Surveillance Audit - Year Two.
    • Re-Aduit (Re-Certification Audit) - Year Three.
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    BSI support

    BSI is a recognized AO providing QMS certification through MDSAP.

    We are also a Conformity Assessment Body for EN ISO 17021-1 as accredited by the Dutch Accreditation Council & UK Accreditation Service. We offer:

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    BSI Support

    Preparation support

    Ensuring product development meets regulatory requirements is essential. At BSI, we provide training to support you through the application process.

    Global Market Access

    BSI Group Americas inc. is a recognised Auditing Organization

    In addition to the 5 MDSAP member countries, the MDSAP affiliate members utilize the reports and certificates for market entry.
    Transfer Support

    Seamless Transfer

    We can offer a seamless transfer service with comprehensive support and the absolute minimum level of disruption.

    Which markets does MDSAP certification cover?

    MDSAP is indicated for global manufacturers looking to export their medical devices into different countries participating in the program. These are:

    • Australia: The Therapeutics Goods Administration.

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    • Brazil: The Brazilian National Health Surveillance Agency.

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    • Canada: Health Canada.

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    • Japan: The Ministry of Health, Labour and Welfare, Pharmaceutical and Medical Devices Agency.

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    • United States: U.S. Food and Drug Administration’s Centre for Devices and Radiological Health.

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    Insights & Media

    MDSAP resources to support you

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    MDSAP - Two scientists working in a laboratory
    Why BSI

    BSI and MDSAP: our commitment to excellence

    Here at BSI, we are an Auditing Organization for MDSAP. We also offer MDSAP in combination with CE, UKCA, ISO 13485 and ISO 9001 assessments.

    We have been active since MDSAP inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs. Our commitment to trusted excellence includes:
    • A global network of over 200 MDSAP assessors.
    • More than 240 ISO 13485 QMS assessors worldwide.
    • In-house Product experts and auditors.
    • Access to a dedicated team of technical and clinical specialists.

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    How do I apply for MDSAP?

    For clients holding ISO 13485, BSI can roll the MDSAP audit into the existing certification cycle. Contact us for more on how to apply for MDSAP.

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