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  • 1.  Devices for charity in Peru?

    This message was posted by a user wishing to remain anonymous
    Posted 09-Feb-2024 14:52
    This message was posted by a user wishing to remain anonymous

    Hello, 

    We have received a request from a US charity organisation that performs surgeries to underserved communities in Peru. They would like us to donate some devices that they will bring to Peru to treat patients there. It is an implantable devices that is 510(k) cleared. We do not have any registrations or approvals in Peru. 

    Does anyone have insight into the Peruvian regulatory approval process in this situation? Are there any exceptions in place for charity use?

    The information we have received from the charity organisation is that there is no problem as long as the products are not expired. 

    All help regarding regulations in Peru is welcome (I'm fluent in Spanish so relevant links to Peruvian sites is also useful) or other general recommendation for how the request can be handled. We want to help but not risk putting us in bad situation.

    Kind regards, 

    Anon



  • 2.  RE: Devices for charity in Peru?

    Posted 10-Feb-2024 15:12

    Hi Anon

    I see there was a resolution back in 2015 on import of donated products that might be relevant.

    https://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2015/resolucion-directoral-n-060-2015-minsa/



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Devices for charity in Peru?

    Posted 11-Feb-2024 06:36

    Hello Anon,

    You can also work through WHO as they have programmes for those type of activities where cleared or approved devices into other countries without a strong regulatory framework can be used.  If you are already working with a charity organisation in the country, they should also be able to assist in working with the Peru authorities or an in-country consultant as well for any registrations.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Consultant
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 4.  RE: Devices for charity in Peru?

    This message was posted by a user wishing to remain anonymous
    Posted 12-Feb-2024 09:02
    This message was posted by a user wishing to remain anonymous

    Thanks, very helpful!! With this I can sort out the details with Charity organization. 


    Original Message


  • 5.  RE: Devices for charity in Peru?

    Posted 12-Feb-2024 10:58

    Hello Anon,

    My company has coordinated charitable expeditions to Peru [also 510(k) cleared devices] for over a decade. We currently contract with a local "Technical Director" at a pharmacy, to act as a regulatory representative. To import product, even for humanitarian purposes, it must still be registered (market authorization) by DIGEMID. This process typically entails transfer of technical documentation including but not limited to: FDA Certificate to Foreign Government (CFG), labeling docs (e.g., IFU, Surgical Technique Guide), Risk Management documentation, verification & validation reports, and a Declaration of Conformity. Lately the process has taken ~6-12 months for registration of new product and/or renewals (certificates expire, typically 5 years). Unfortunately the cultural differences have occasionally resulted in miscommunications, delayed timelines, etc. so be sure to plan for unexpected turbulence. 

    Best of luck!



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    Michael Thomas, RAC
    Director Regulatory Affairs
    Salt Lake City UT
    United States
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    Original Message


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