Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

the transfer according to RDC102/2016 is free?

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There's no related tax, so yes, it's "free".

it is possible to change a legal manufacturer ?

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Not under 102.

thank you!
is there any other law for manufacturer changes ?

It's a specific petition you need to submit to ANVISA.

thank you!

hi guys!

Just for your information, the transfer of BGMP and cadastro is free. for registro transfer[FONT=&quot] 2500 real[/FONT]

Hi, you are right, my mistake. For the cadastro transfer (and related GMP transfer), there's no fees.

For registro, you need to pay the registro fee for transfer. However, the fee is not fixed, as it's the difference on the value of the TFVS (Taxa de Fiscalização de Vigilância Sanitária) - this requirement comes from LEI Nº 13.097, DE 19 DE JANEIRO DE 2015. - Item 25-B.

thank you !

Hi Marcelo!

what does "A documentação aguarda a conclusão da certificação de boas práticas de fabricação" mean ? Does it mean that the file review is finished and ANVISA wait for GMP to publish the registration?
Thank you!

what does "A documentação aguarda a conclusão da certificação de boas práticas de fabricação" mean ? Does it mean that the file review is finished and ANVISA wait for GMP to publish the registration?

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Yes. However, it's finished for the time being. They "may" review some stuff again or even perform the review again when the GMP certification is published (because this may take many years).

Hi Marcelo,

Thanks for the valuable info. Would you happen to know what are the fees involved with Cadastro application and lead time for approval assuming it is class I (non-electrical, non sterile, non-invasive) device?

Many thanks,
David