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.
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.