Landing PPE in a regulated market
FDA, CE and ANVISA are three separate routes, and product that satisfies one can be stopped at the border by another.
Registration is per market
The syringe needle in this catalogue carries CE, FDA and ANVISA — three registrations because it is sold into three regulatory regions. A glove carrying only FDA is not thereby cleared for the EU, and a CE-marked glove is not thereby cleared for the US.
ANVISA and Brazil
ANVISA is the Brazilian health regulator, and Brazilian import of medical devices runs through it. If Brazil is your destination, the registration has to exist before the goods sail, not after they land.
CE marking is a self-declaration for some classes
For lower-risk classes, CE marking rests on the manufacturer's declaration of conformity supported by test evidence; for higher-risk classes a notified body is involved. Ask which route was used and, where a notified body was involved, for its number.
Who is the importer of record
The regulatory obligations attach to the importer as well as the manufacturer. Establish who holds that role in your transaction before the container is booked, because it determines who carries the compliance risk.
Where this applies in the catalogue
The guidance above is general. Applied here, it lands hardest on the syringes & needles family.
