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Some countries require the registration with the competent authorities of IVDs that are sent to laboratories as part of the performance evaluation procedure of design and development process (so NOT definitive product yet).
Does Brasil also have registration requirements regarding IVDs that are for performance evaluation only (PEO)?
We want to ship a kit that is in the second phase of performance evaluation. This PEO-kit will be shipped to only one Brasilian laboratory.
Does this kit have to be registered with ANVISA as a performance only kit or are there other ANVISA-requirements regarding PEO-kits?
Thank you in advance for the information.
Paperman.
Does Brasil also have registration requirements regarding IVDs that are for performance evaluation only (PEO)?
We want to ship a kit that is in the second phase of performance evaluation. This PEO-kit will be shipped to only one Brasilian laboratory.
Does this kit have to be registered with ANVISA as a performance only kit or are there other ANVISA-requirements regarding PEO-kits?
Thank you in advance for the information.
Paperman.