Requirements for Humanitarian supply of Medical Devices to Jamaica

E

ElmerF

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
 

Ronen E

Problem Solver
Moderator
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

You could supply the devices to the US physician in the US. The implementing party could then handle the transfer to Jamaica, with you supporting them with any required information.

In some countries a physician is able to import devices for own use (no distribution or commerce) without excessive registration.
 
Last edited:
E

ElmerF

Thanks Guys. Sounds like we could supply the devices as initial use samples free of charge to the physician and that he would be responsible for any further registration after that.
 
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