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  • MDSAP Update 1574394615

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    Yesmil Pena
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    The document outlines the timeline of the Medical Device Single Audit Program (MDSAP) from its beginnings in 2012 to full implementation in 2019. Key events included the memorandum of understanding in 2012, Japan and Canada joining in 2014 and 2016 respectively, and the transition period ending in 2019. The program allows medical device manufacturers to undergo a single audit to satisfy the requirements of participating regulatory authorities like the FDA, TGA, and ANVISA.

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    MDSAP UPDATE

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    MDSAP_Update_1574394615

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    The document outlines the timeline of the Medical Device Single Audit Program (MDSAP) from its beginnings in 2012 to full implementation in 2019. Key events included the memorandum of understanding in 2012, Japan and Canada joining in 2014 and 2016 respectively, and the transition period ending in 2019. The program allows medical device manufacturers to undergo a single audit to satisfy the requirements of participating regulatory authorities like the FDA, TGA, and ANVISA.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    43 views1 page

    MDSAP Update 1574394615

    Uploaded by

    Yesmil Pena
    The document outlines the timeline of the Medical Device Single Audit Program (MDSAP) from its beginnings in 2012 to full implementation in 2019. Key events included the memorandum of understanding in 2012, Japan and Canada joining in 2014 and 2016 respectively, and the transition period ending in 2019. The program allows medical device manufacturers to undergo a single audit to satisfy the requirements of participating regulatory authorities like the FDA, TGA, and ANVISA.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 1

    MDSAP UPDATE

    Pre-Pilot MDSAP Pilot Transition Full MDSAP

    STARTED
    20 20 20 20 20 20 20 20 20
    12 13 14 15 16 17 18 19 20

    Memorandum of Japan joins Proof of End of


    Understanding MDSAP Concept Review transition
    period from
    Canada announces transition from CMDCAS to
    CMDCAS to MDSAP MDSAP

    Regulatory Authority Specific Benefits

    Full transition to MDSAP FDA accepts MDSAP Takes into account Program outcomes and May accelerate the
    completed on Jan 1, 2019 audit reports as a MDSAP audit reports reports used as key input Marketing Authorization
    substitute for routine when deciding whether to into ANVISA’s pre-market and reduce post-market
    Agency inspections issue/maintain TGA and post-market burden – Trial until March
    Conformity Assessment assessment procedures 2020
    Certificates (when
    Certificate required)

    2019 TGA

    1
    Jan AUDIT

    Allows recognized Auditing Organizations (AOs) to conduct a single


    audit of a medical device manufacturer that will satisfy the relevant
    requirements of participating RAs

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