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Costa Rica - Class I (Non sterile, Non Measuring) Medical Devices Manufacturer

  • 1.  Costa Rica - Class I (Non sterile, Non Measuring) Medical Devices Manufacturer

    Posted 13 days ago
    Edited by Arslan Rahat 13 days ago

    Hello RAPS Team, 

    What are requirements for Class I (Non sterile, Non Measuring) Medical Devices foreign manufacturer  to send devices to Costa Rica as per their regulations?

    Do we need REP in Costa Rica like EU REP?


    Is distributor in Costa Rica enough to import and sell devices in Costa Rica?

    Does distributor in Costa Rica, need to list, devices data in their database just like PARD and FDA listing database?
    Would appreciate your assistance.

    Thanks - Arslan



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    Arslan Rahat
    QARA Manager
    Toronto ON
    Canada
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