Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

[Marcelo]

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

Hello David, and welcome to the Cove!

Cadastro fees, as all other ANVISA fees, depend on the size of the registration holder, but in the case of Cadastro it will be at maximum BR$ 3.514,32.

Lead time right now is more or less 60 days.

 

[marmary]

Hi Marcelo,
Thanks for all your valuable information and experience that you share here.
I have some questions regarding the MDSAP and Factory inspection for INMETRO. Currently our company has the MDSAP certificate and IEC 60601-1 certificate from ILAC-certified lab. We have two different products(Class I and Class IIa). Now, we are going to apply for INMETRO Certificate and the CB sent us a quote including factory inspection fee. As far as I know, factory inspection is assessment to ensure compliance of manufacturer's production. My questions are : Doesn't the MDSAP Certificate cover the factory inspection requirement? if not, what is the difference of them? ' and 'what is the best approach for us to get the INMETRO Certificate?'
Thanks

 

[Marcelo]

Hi Marcelo,
Thanks for all your valuable information and experience that you share here.
I have some questions regarding the MDSAP and Factory inspection for INMETRO. Currently our company has the MDSAP certificate and IEC 60601-1 certificate from ILAC-certified lab. We have two different products(Class I and Class IIa). Now, we are going to apply for INMETRO Certificate and the CB sent us a quote including factory inspection fee. As far as I know, factory inspection is assessment to ensure compliance of manufacturer's production. My questions are : Doesn't the MDSAP Certificate cover the factory inspection requirement? if not, what is the difference of them? ' and 'what is the best approach for us to get the INMETRO Certificate?'
Thanks

Hi
No, the INMETRO certification is a separate process. You can use MDSAP to comply with ANVISA requirements. INMETRO requirements (which is an ISO type 5 certification) is a product certification, which includes evaluation of the device (in type testing) and also the manufacturing process (in an audit). Current requirements for the INMETRO processo do not recognize MDSAP certificates or reports (and they probably never will), so you still need to be audited.

 

[marmary]

Hi
No, the INMETRO certification is a separate process. You can use MDSAP to comply with ANVISA requirements. INMETRO requirements (which is an ISO type 5 certification) is a product certification, which includes evaluation of the device (in type testing) and also the manufacturing process (in an audit). Current requirements for the INMETRO processo do not recognize MDSAP certificates or reports (and they probably never will), so you still need to be audited.

Tank you very much for clarification.

 

[kdawg]

bump

 

[marmary]

Hi Marcelo,
Thanks again for sharing your valuable information here. I have another question in regard to the regulatory requirements in Brazil. For registration of medical devices with software (software as a component of the device not stand alone SW) , Is there any requirement for translation of software to Portuguese? Or is it required for getting INMETRO certificate(eg. as a requirement for usability)?
Thanks

 

[Marc]

NOTE: Marcelo doesn't stop by here these days. Someone else may be able to answer.

 

[marmary]

NOTE: Marcelo doesn't stop by here these days. Someone else may be able to answer.

Thanks for letting me know. It would be appreciated if anyone else can help on this.