Hello--
My company manufactures a medical device that is used for oral strength measurement and rehabilitation. It has been on the US market and various other international markets for years. Our device is sometimes used by clinical researchers as part of experimental treatment regimens or to assess the efficacy of a given clinical intervention.
We have received a request from a researcher in Brazil, where our device is not registered, asking that we ship them a device under their country's clinical research exemption. Brazil's regulation (as translated by Google) defines clinical research as "Research using human beings, aimed at verifying the performance, safety and efficacy of a medical device."
My question is:
If our device will be used as a tool in a clinical study, but the study is not explicitly being conducted to evaluate our device's performance, safety, or efficacy, can we ship it to Brazil under the clinical research exemption? My feeling is that our device doesn't qualify as a device for clinical research, because it is not under development, and the study is not assessing a new intended use, design change, etc. However, a colleague believes that because the device will be used as a tool in the study, the study will indirectly assess the performance, safety, and efficacy of our device (e.g., if a performance or safety issue arises, it would be captured as part of the study data), so we should be able to use the exemption.
I'm curious if any of you have experience with importing non-registered devices for clinical research (to Brazil or other markets) where they are to be used to facilitate the study, instead of being the subject of the study.
Thanks in advance!
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Caitlin
Regulatory Specialist
Washington
USA
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