Brazil IVD Registration Fees

[alt78]

Hello,

Please does anyone know the current fee for registration of a class II IVD in Brazil?

Thanks

 

[Marcelo Antunes]

Hello, and welcome to the Cove!

ANVISA fees depend on the registration holder "size". It also depends on the size of the device.

Fees for a class II IVD device range between BR$ 1100 to BR$ 24000.

You can see the fees here: http://portal.anvisa.gov.br/documents/33888/2843328/Anexos+-+novos+valores+TFVS+_final.pdf

 

[GLM12345]

Marcelo - can you tell me what the regs are for "ammendment" to a registration in Brazil?

 

[Marcelo Antunes]

Values are
R$ 5.228,91
R$ 4.444,57
R$ 3.660,24
R$ 2.091,56
R$ 522,89
R$ 261,45

(depending on company "size").