Classification and Fees for Registration of IVDs in Brazil

[slglover65]

Hi All

I know that IVDs are classified as I, II, III and IIIa, but does anyone know of a document that details what type of IVD would be in each class? For example, what classes would IVDs for the detection of say HIV or thyroid hormones be in (presumably, very different ones )

Also, I have read a translation (probably not a very good translation) of RDC 222/2006 and I can't for the life of me work out the fees for an alteration to an existing IVD registration. I know that the fee is based on annual revenue of the company and maybe IVD classification, but even a range would be good enough.

If anyone could help, I would greatly appreciate it.

Thanks

 

[Stijloor]

Hi All

I know that IVDs are classified as I, II, III and IIIa, but does anyone know of a document that details what type of IVD would be in each class? For example, what classes would IVDs for the detection of say HIV or thyroid hormones be in (presumably, very different ones )

Also, I have read a translation (probably not a very good translation) of RDC 222/2006 and I can't for the life of me work out the fees for an alteration to an existing IVD registration. I know that the fee is based on annual revenue of the company and maybe IVD classification, but even a range would be good enough.

If anyone could help, I would greatly appreciate it.

Thanks

A quick bump!

Can someone with this expertise help?

Thank you very much!!

Stijloor.

 

[Stijloor]

Hi All

I know that IVDs are classified as I, II, III and IIIa, but does anyone know of a document that details what type of IVD would be in each class? For example, what classes would IVDs for the detection of say HIV or thyroid hormones be in (presumably, very different ones )

Also, I have read a translation (probably not a very good translation) of RDC 222/2006 and I can't for the life of me work out the fees for an alteration to an existing IVD registration. I know that the fee is based on annual revenue of the company and maybe IVD classification, but even a range would be good enough.

If anyone could help, I would greatly appreciate it.

Thanks

Another quick bump.

Can someone help?

Thank you!!

Stijloor.

 

[kirmer]

Hi All

I know that IVDs are classified as I, II, III and IIIa, but does anyone know of a document that details what type of IVD would be in each class? For example, what classes would IVDs for the detection of say HIV or thyroid hormones be in (presumably, very different ones )

Also, I have read a translation (probably not a very good translation) of RDC 222/2006 and I can't for the life of me work out the fees for an alteration to an existing IVD registration. I know that the fee is based on annual revenue of the company and maybe IVD classification, but even a range would be good enough.

If anyone could help, I would greatly appreciate it.

Thanks

I found this from ANVISA. I hope it helps

 

[slglover65]

Thank you so much. That is very helpful.

Have a great day.

Sarah