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Clinical research - Request from ANVISA

#1
I received a request from ANVISA that says the following: '' Submit specific clinical research for the system object of this registration process in order to assess the clinical behavior of the saline to observe the real result of the device's behavior when implanted; considering that the results of pre-clinical tests will require clinical confirmation in view of the risks inherent to this type of stage in the manufacture of the device "

Could you please guide me to what should be done?
 
Elsmar Forum Sponsor
#2
Hi,

Do you have any special manufacturing process that could affect the product's implantation so ANVISA can request a clinical evaluation? What is the deadline for you to meet this requirement?
 
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