MDSAP – Medical Device Single Audit Program

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    MDSAP program - TS Quality & Enginering

    The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organisations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems.

    MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

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    The program’s goals include:

    • Development of an international coalition to improve medical device safety and oversight on an international scale
    • Creation of a single audit program that provides confidence to international regulators
    • A minimized regulatory burden on the medical device industry
    • Enabling government regulatory authorities to focus on critical/problematic manufacturers, allowing notified bodies to conduct inspections on their behalf
    • More efficient and less burdensome regulatory oversight of medical device manufacturers’ quality management systems
    • More effective use of regulatory resources through work-sharing and mutual acceptance among regulators
    • Better global alignment of regulatory approaches, and technical requirements based on consensus standards and best practices

    The Medical Device Single Audit Program 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.

    MDSAP – Medical Device Single Audit Program Resources

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    THE MDSAP PARTICIPATING REGULATORS INCLUDE:

    Australian Therapeutic Goods Administration (TGA)
    TGA will use an MDSAP audit report as part of the evidence that is assessed in compliance with Medical Device market authorisation requirements, unless the Medical Device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports.

    The Brazilian National Health Surveillance Agency ANVISA 
    (Agência Nacional de Vigilância Sanitária)
    ANVISA will utilise the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support the regulatory technical evaluation on these issues.

    Health Canada (HC)
    Health Canada’s intent is to implement the MDSAP as the mechanism to assess regulatory compliance for quality management system requirements in Canada. As of December 31, 2018, Health Canada has terminated the Canadian Medical Device Conformity Assessment System (CMDCAS) program. Health Canada now only accepts MDSAP certificates for the purpose of Medical Device License application or maintenance.

    US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
    FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA will not be affected by this program. Moreover, MDSAP will not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval or PMA applications.

    Japan Ministry of Health, Labor and Welfare
    Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the MDSAP audit report as a trial:
    1) To exempt a manufacturing site etc.* from on-site inspection, and/or
    2) To allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report. 

    Medical Device Single Audit Program process

    MDSAP is based on a three year audit cycle.

    What are the benefits of MDSAP?

    A Single Audit by Auditing Organizations would:

    • minimize medical device manufacturer disruptions due to multiple regulatory audits
    • provide predictable audit schedules (agenda with opening and completion dates)
    • benefit patient health and patient access with ease of entry to multiple markets
    • leverage regulatory resources
    • incorporate ISO 13485 assessment
    • requirements, including Australia, Brazil, Canada, Japan and US
    • reduction in time and resource dealing with findings from multiple audits
    • reduction in the cost of audits in comparison to independent audits
    • improved transparencies in the industry

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