Medical Device Registration in Brazil for Private Label Manufacture

Hello Folks

I have recently stumbled on this treasure of a forum, so I am excited to be here and meet you all.

My question is regarding medical device registration (class III) in Brazil of private label manufacturer based in Germany, with manufacturing also based in Germany. Is it possible, are there any specific things different in the process, any information regarding this would be helpful.

Many thanks and I look foreword to your answers and being part of the family.

A Quick Bump!

Can someone help?

Thank you very much!

Another quick "Bump". My Thanks in advance to anyone who can help with this one.

Hello Ryan and Welcome to the Cove!

Hum ,I´m not sure that I understand your question. You mean, you are the manufacturer for another company, and want to register the device you manufacturer for this company in Brazil? Or the other way around?

Hello Marcelo

We are a private label manufacturer from Germany and want to register in Brazil to sell there. Is it possible given the fact that we are a PLM and are there any thing different in the process.

Thanks for your help

Hello Ryan

We are a private label manufacturer from Germany and want to register in Brazil to sell there. Is it possible given the fact that we are a PLM and are there any thing different in the process.

Click to expand...

Sure it´s possible, however, you need to devise a solution on exactly how you´re planning to "sell" the device. For example, the classic way to register in Brazil from aboard is to have the finished device (meaning, you register the device in your country) ship to Brazil, then the only thing the Brazilian registration holder do it to attach the Brazilian label. If you do not create a finish device (which might be the case for you as a PLM), one solution is to import the device as part, and then the BRH "finishes" the manufacturing process by applying their own label. This might not be a great solution because then you would be something like the PLM for the BHR, but it´s a possibility.

Anyway, it´s possible, but you need to verify the possibilities due to the nature of your work.

Thanks Marcelo for all your feedback. It is greatly appreciated.

Ryan