Brazil clinical data/trial requirement

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itscloud

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#1
#1
Hi all,

What is the requirement for clinical data in Brazil for Class III and IV device?

What is the definition of clinical data in Brazil?

Can clinical data be from substantially equivalent device? Or the clinical data must be involved with actual trials?
 
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kys123

kys123

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#2
#2
Clinical data is defined by Anvisa as: data obtained from studies that assessed the performance, safety and efficacy of a medical device in human beings.

Yes, you can use data from substantially equivalent devices and their published literature, as long as they come from studies that comply to the definition above.
 
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