Brazil IVD Registration Fees

alt78 · Oct 25, 2016

Hello,

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

Thanks

Marcelo Antunes · Oct 25, 2016

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 · Jan 9, 2019

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

Marcelo Antunes · Jan 11, 2019

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").

Thread starter	Similar threads	Forum	Replies	Date
J	INMETRO process of Hypodermic Needle in Brazil	Medical Device Related Regulations	1	Nov 19, 2018
L	Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil	Other Medical Device Regulations World-Wide	2	Jun 25, 2012
P	IVD Classification in Brazil and Anvisa Guidance	Other Medical Device Regulations World-Wide	10	May 23, 2012
B	IVD ANVISA Registration Process in Brazil and Registration Change	Other Medical Device Regulations World-Wide	11	Jan 4, 2012
S	Classification and Fees for Registration of IVDs in Brazil	Other Medical Device Regulations World-Wide	4	Nov 10, 2011