September 17, 2025
Luiz Levy, Priscila Sanada and Evangeline Loh
Background
In June 2025, ANVISA published RDC No. 977/2025, formalizing its intent to modernize administrative control in foreign trade. The resolution established the phased integration of import processes.
Single Import Declaration Portal (DUIMP)
The Single Import Declaration (DUIMP) on the new Single Foreign Trade Portal replaced the Siscomex system. The new portal now permits one system for licensing, ANVISA’s authorizations, and customs/tax procedures.
The Brazilian Federal Revenue Service and ANVISA would be able to access documents in real time in DUIMP, which would result in faster regulatory decisions and quicker importation clearance. ANVISA publicized that it required only 10 minutes after registration to release cargo.
DUIMP Manual affirms DDR importation path
ANIVSA published version 1.0 of the Importation Manual for DUIMP (Sept. 16), which was compiled based on RDC 947/2024 and RDC 977/2025 requirements. In Section 8.2.1 on direct importation, ANVISA affirms that the importation by another importer not classified as the Brazilian Registration Holder (BRH) will still be permissible. The Declaration of Registration Holder (DDR) model continues.
Concluding remarks
During the summer, ANVISA hinted that importations would need to be performed by the BRH or Health Unit, removing the importations currently performed by an importer not classified as the BRH. However, based on the DUIMP manual, Emergo by UL is pleased that importation performed by an importer that is not the BRH will still be possible. The professional BRH entities, such as Emergo by UL Brazil, will continue to be able to serve as the BRH, and importation can be performed by another entity, an importer, who is appropriately qualified and located.
There will still need to be an update to the importation regulation, RDC 81/2008, followed by stakeholder discussion.
