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 But the RDC 350 has been revoked by Resolução RDC nº 81, de 05 de novembro de 2008.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