Brazil - Import Medical Device Spare Parts - Without license

apuigvert

Involved In Discussions
Hello all!,

I was hoping you can help me with a situation. We have a valid license for a device in Brazil. This license will end soon and we are not planning on further market this specific device in Brazil (but a succeeding model).

BUT we already sold some of the devices in Brazil and we are now wondering what will happen to the accessories/disposables which were listed on the license?

Are we still allowed to deliver those accessories/disposable to their clients who bought the main device?

Thank you very much in advance!
 

apuigvert

Involved In Discussions
If the part is not a medical device, it's not regulated by ANVISA, so you would not need an ANVISA permit or anything to do so.
Actually, some consumables could be considered a medical device (i.e. infusion guides). If those consumables were included in the license that expired, should we submit a new license for them? Thanks!
 

Marcelo

Inactive Registered Visitor
Actually, some consumables could be considered a medical device (i.e. infusion guides). If those consumables were included in the license that expired, should we submit a new license for them? Thanks!

When you say license, do you mean product registration (or cadastre in the case of Class I and II), right?

If so, you need to have valid product registrations to sell to Brazil.
 
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