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Hello,
My company has been approached by a US physician that performs humanitarian medical procedures in Jamaica. Manufacturers provide him with medical devices free of charge. We would like to participate but I cannot find any information on the regulations for providing medical devices on a humanitarian basis. We have CE mark and our device is a class II 510K in US. We do not have any registration in Jamaica. What would we need to do from a regulatory perspective to provide these devices for charitable purposes?
Any advice appreciated.
Thanks,
ElmerF
My company has been approached by a US physician that performs humanitarian medical procedures in Jamaica. Manufacturers provide him with medical devices free of charge. We would like to participate but I cannot find any information on the regulations for providing medical devices on a humanitarian basis. We have CE mark and our device is a class II 510K in US. We do not have any registration in Jamaica. What would we need to do from a regulatory perspective to provide these devices for charitable purposes?
Any advice appreciated.
Thanks,
ElmerF