Regulatory Open Forum

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  • 1.  Costa Rica Manufacturing Facility

    Posted 24-Jun-2015 10:27
    I am looking for the pathway to procure a legal document from the Costa Rican government for a new Costa Rica manufacturing site (in a free trade zone).  The document would acknowledge the site and declare that the product manufactured at the plant there may be marketed in Costa Rica.  Something equivalent to a US CFG.  What is the pathway/whom should I contact?

    Thank you, 

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    Julia Leslie, PhD
    Regulatory Specialist
    United States
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  • 2.  RE: Costa Rica Manufacturing Facility

    Posted 29-Jun-2015 16:51
      |   view attached
    Hello Julia,

    You need to request a proof of registration (Certificado de Registro de Equipo y Material Biomedico) issued by Ministerio de Salud de Costa Rica. This certificate should include the information you need.

    I am attaching for your information the list of Costa Rican approved medical devices published at http://www.ministeriodesalud.go.cr/index.php/registro-de-productos-de-interes-sanitario?id=637

    Please let me know if this helps or if I can be of any further assistance.

    Have a pleasant day!

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    Marcela Saad MSc, PharmD, RAC Global
    President & Senior Consultant
    MarcM Consulting Canada
    Kitchener ON
    Canada
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    Attachment(s)

    xls
    Costa Rica Approved MD Products.xls   3.60 MB 1 version
    Original Message