Pre-clinical Studies for RUO Product

#1
Hi Everyone!

I would like to know if there are requirements that we would need to comply if we intend to conduct the pre-clinical studies for IVD medical devices at various countries such as Indonesia, Malaysia, Thailand and Philippines? Do we need to label our device as RUO product? The objective of such studies will provide feedback to improve our current product development.

Appreciate your input.
 
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Ronen E

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#2
Hi,

I'm not sure I understand what "pre-clinical studies for IVD medical devices" means here. Usually "pre-clinical" refers to animal studies or (less commonly) bench studies, i.e. not involving humans, and these don't commonly span multiple countries. "Feedback to improve our current product development" could mean different things - are you intending to evaluate the device's performance?
 
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