Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Marcelo Antunes

Addicted to standards
Staff member
Admin
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.
 
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 Antunes

Addicted to standards
Staff member
Admin
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.
 
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.
 
Top Bottom