Brazilian - Medical Device Performance Evaluation Only - Registration Requirements

P

Paperman

#1
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.
 
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Stijloor

Staff member
Super Moderator
#2
Re: Brazilian - Medical Device Performance Evaluation Only - Registration Requirement

A Quick Bump!

Can someone help?

Thank you very much!!
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Brazilian - Medical Device Performance Evaluation Only - Registration Requirement

Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 
M

Mondo 22

#4
Re: Brazilian - Medical Device Performance Evaluation Only - Registration Requirement

Marcelo Antunes is your man for this.

He is a moderator on the forum, im sure he will be able to help
 

Marcelo

Inactive Registered Visitor
#5
Re: Brazilian - Medical Device Performance Evaluation Only - Registration Requirement

As far as I know, Anvisa does not have clear requirements for PEO. However, it would be the same case as a product under clinical research, which do not require registration but has a requirement that Anvisa is informed and consent with it´s use in Brazil. I think that your case would fall on the same idea.
 
E

emron428

#6
Re: Brazilian - Medical Device Performance Evaluation Only - Registration Requirement

Has ANVISA assembled a table of exactly what it would cost to register your product with them based on their classification? I've been unable to find such a compilation on their website or anywhere else.

Many thanks.
 
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