Who pays Brazil ANVISA Inspection Fees

[sreenu927]

Hi all,

For ANVISA inspection to foregin manufacturing sites, the fees is US20K, from my knowledge.

This inspection occurs every two (2) years.

My question is who has to bear the inspection fees? Is the (foreign)manufacturer or ANVISA?

Thanks for your answer!

Regards,
Sreenu

 

[MIREGMGR]

Re: Brazil ANVISA Inspection Fees

Emergo's Latin America specialist did a live webinar yesterday in which she said that the current fee is equivalent to US$24,000, payable by the applying/inspected firm. That was described as an all-up fee, including travel, lodging/meals, and a translator if needed for the two-person, five-day audit.

 

[NewRegMan]

Re: Brazil ANVISA Inspection Fees

Where can I get some information (more details) about this webinar?

Thanks in advance & best regards,
Guido

 

[sreenu927]

Hi MIREGMGR,

Thank you very much!!

https://www.emergogroup.com/files/brazil-webinar-presentation-september-2011.pdf

Hi NewRegMan,

Above link has got the webinar presentation slides.

Regards,
Sreenu

 

[MIREGMGR]

I haven't looked to verify, but supposedly the audio of the presentation--much more informative than the slides--was supposed to be available on their website as of yesterday.

I'm not vouching for their information, of course.

 

[patiofl]

What are the typical cost involved for a CE approved class IIa device to get both INMETRO and ANVISA approvals?

 

[Marcelo]

What are the typical cost involved for a CE approved class IIa device to get both INMETRO and ANVISA approvals?

There´s no simple answer to this because it depends on a lot of things.

Let´s use an example scenario:

1 - Inmetro certification: IF you have acceptable test reports and thus does not have to perform tests, the typical costs would be

1a - CB cost - between US$ 3.000 and 10.000
1b - Audit cost - some US$ 1.500

2 - Anvisa process - if it´s only cadastre (meaning, it´s a class II here without registration and thus without the need of a B-GMP certificate), Anvisa taxes are something between US$ 45 and 900.

If it´s registration and thus requiring B-GMP, you need to additionally pay US$ 18500 (as of the dollar value today).

This is only for the usual taxes/services.

 

[Marcelo]

and a translator if needed for the two-person, five-day audit.

Just an addendum, the fee does not include a translator, what manufacturers are doing is sending someone from Brazil to accompany (and translate if needed) the inspection.

 

[tibon74]

Hi!

We have submitted last september an inspection ANVISA request for our company in France. Is it true that it takes 1 years to have an answer from ANVISA? Is there a rule for inpection schedule ?
thanks !
Regards

 

[Marcelo]

We have submitted last september an inspection ANVISA request for our company in France. Is it true that it takes 1 years to have an answer from ANVISA? Is there a rule for inpection schedule ?

Hello Taieb

In fact, it´s taking 2 years. In may 2012 Anvisa was scheduling inspections requested in June 2010. The are no defined rules (at least oficcially), but Anvisa is scheduling based on request date.