Import of medical devices to Brazil without registration possible ?

Paramedic · Jan 20, 2010

Hallo everyone !
Is there a way that allows to import medical devices without ANVISA-registration to Brazil (for example for demonstration and training purposes) ?

intl1 · Jan 20, 2010

It is possible however it can be very expensive, you have to import on a temporary importation visa for each item which will require you to ship it back out of the country. You need to speak to a freight forwarder that handles shipments to Brazil.

Marcelo · Jan 21, 2010

Hello, it´s possible, there are in the regulations, as generally regulations have, requirements for products which are to be showed at trade shows or for similar purposes (including clinical research), but you have to fulfill those requirements.

The sanitary regulation is RDC 350 (http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=20313&word, in portuguese), but there are also other requirements from brazilian customs.

Paramedic · Jan 22, 2010

Thanks, Marcelo and intl.
I have just followed your posted link to the RDC 350. But the RDC 350 has been revoked by Resolução RDC nº 81, de 05 de novembro de 2008.
And that's the problem I have: In my opinion, RDC81 is a bit confusing due to the large amount of considerations mentioned in this RDC (and due to portuguese language).
I am not in charge with the logistic issues such as consulting a freight forwarder etc., since our brazilian distributor manages this issues. My only concern is: which proof(s) do I need to approve the products here in Germany for delivery ?
So the questions regarding this matter are:
1) Is an import licence always necessary ?
2) Who issues this import licence ?
3) Can anyone give me an example (picture etc.) of such a licence ?
4) If a governmental or public institution requests a "special import": is there also an import licence necessary or is an "official request" sufficient ?

Marcelo · Jan 22, 2010

I have just followed your posted link to the RDC 350. But the RDC 350 has been revoked by Resolução RDC nº 81, de 05 de novembro de 2008.

Yep, sorry for that. We still are used to talk about RDC 350 when talking about importing, even it being revoked. mY bad.

Also, i´ve never been primarly involved with the technical requirements for imports, so theese informations is what i´ve read or been told by friends which import:

1 - a import license is always necessary.
2 - it´s issued by Anvisa
3- i dont have one
4 - i´m pretty sure you still need to follow RDC 81, meaning you still need the import license and everything

More on that, on RDC 81, can be found in the chapter: SEÇÃO II - DA ADMISSÃO TEMPORÁRIA

recruit · Mar 2, 2010

Paramedic said:
Thanks, Marcelo and intl.
I have just followed your posted link to the RDC 350. But the RDC 350 has been revoked by Resolução RDC nº 81, de 05 de novembro de 2008.
And that's the problem I have: In my opinion, RDC81 is a bit confusing due to the large amount of considerations mentioned in this RDC (and due to portuguese language).
I am not in charge with the logistic issues such as consulting a freight forwarder etc., since our brazilian distributor manages this issues. My only concern is: which proof(s) do I need to approve the products here in Germany for delivery ?
So the questions regarding this matter are:
1) Is an import licence always necessary ?
2) Who issues this import licence ?
3) Can anyone give me an example (picture etc.) of such a licence ?
4) If a governmental or public institution requests a "special import": is there also an import licence necessary or is an "official request" sufficient ?

Recent several years, we sent a lot of devices to Brazil for INMETRO test by temporarily importation without anvisa registration. Just contact professional freight company who can handle everything.

Import of medical devices to Brazil without registration possible ?

Paramedic

intl1

Marcelo

Inactive Registered Visitor

Paramedic

Marcelo

Inactive Registered Visitor

recruit

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