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Rimsys 2024 RegEx AMA
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PMDA Inspection Including unannounced

  • 1.  PMDA Inspection Including unannounced

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jan-2023 14:07
    This message was posted by a user wishing to remain anonymous

    For foreign manufacturers, does PMDA conduct unannounced inspections? 

    For new device registration (Shonin), does PMDA conduct a pre-market approval inspection or will they accept the MDSAP Report/certificate instead?

    Thanks


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