Medical Device Single Audit Program

Designed to increase efficiency and safety

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  • Standardizing how we audit medical devices on a global scale

    The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. Led by various Regulatory Authorities (RA) worldwide, the initiative is aimed at boosting efficiency and safety through increased consistency. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA. At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program. Sharing knowledge is all part of our service.

    As an independent and recognized auditing organization, DEKRA performs audits within the MDSAP. Our experts have extensive knowledge of and experience with MDSAP and the requirements of the Regulatory Authorities that participate in the program: TGA in Australia, ANVISA in Brazil, Health Canada, MHLW and PMDA in Japan, and FDA in the USA.

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    +31 88 96 83005

    medical.global@dekra.com

    We audit amongst others:

    • Mobile & wearable medical devices
    • In-vitro diagnostic medical devices
    • Active and non-active medical devices
    • Implantable medical devices (active and non-active)
    • Quality management systems

  • Exporting to:

    Australia

    The Therapeutics Goods Administration (TGA) uses an MDSAP audit report as part of the evidence in evaluating compliance with the Australian Conformity Assessment procedure. It may also use the report to support the TGA Conformity Assessment Certification and, in some circumstances, to replace routine TGA inspections.

    Brazil

    The Brazilian National Health Surveillance Agency (ANVISA) utilizes the outcomes of the program, including the reports, to constitute important input into ANVISA’s pre-market and post-market assessment. In addition, it uses the outcomes in the process and, when applicable, supports Good Manufacturing Practice (GMP) certification and provides key information that is expected to support regulatory technical evaluations.

    Canada

    Health Canada (HC) plans to implement the Medical Device Single Audit Program in place of the CMDCAS program as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. HC uses an MDSAP audit and associated MDSAP certification to support medical device licensing for manufacturers intending to sell medical devices in Canada.

    USA

    The USA’s Food and Drug Administration (FDA) accepts the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by the FDA are not affected by this program. Moreover, this program does not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval (PMA) or to any decisions under sector 513 (F) of the act concerning the classification of a device.

    Japan

    Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) uses the MDSAP audit report:

    1) To exempt a manufacturing site from on-site inspection, and/or to support approval as a Registered Manufacturing Site (RMS) and replace JPAL audits under the Japanese ordinance MO169.

    2) To allow a Marketing Authorization Holder (MAH) to substitute a considerable number of documents required for the inspection with the report.

     

    Exporting to:

    Australia

    The Therapeutics Goods Administration (TGA) uses an MDSAP audit report as part of the evidence in evaluating compliance with the Australian Conformity Assessment procedure. It may also use the report to support the TGA Conformity Assessment Certification and, in some circumstances, to replace routine TGA inspections.

    Brazil

    The Brazilian National Health Surveillance Agency (ANVISA) utilizes the outcomes of the program, including the reports, to constitute important input into ANVISA’s pre-market and post-market assessment. In addition, it uses the outcomes in the process and, when applicable, supports Good Manufacturing Practice (GMP) certification and provides key information that is expected to support regulatory technical evaluations.

    Canada

    Health Canada (HC) plans to implement the Medical Device Single Audit Program in place of the CMDCAS program as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. HC uses an MDSAP audit and associated MDSAP certification to support medical device licensing for manufacturers intending to sell medical devices in Canada.

    USA

    The USA’s Food and Drug Administration (FDA) accepts the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by the FDA are not affected by this program. Moreover, this program does not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval (PMA) or to any decisions under sector 513 (F) of the act concerning the classification of a device.

    Japan

    Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) uses the MDSAP audit report:

    1) To exempt a manufacturing site from on-site inspection, and/or to support approval as a Registered Manufacturing Site (RMS) and replace JPAL audits under the Japanese ordinance MO169.

    2) To allow a Marketing Authorization Holder (MAH) to substitute a considerable number of documents required for the inspection with the report.

     

  • Meet our experts

Tamara Garcia
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Tamara Garcia

Medical Device Services
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