Brazil ANVISA Registration — Food, Drug, Cosmetic and Medical Device Imports

HEADLINE: Brazil faced health risks from unregulated imports of food and medical products.

Key Obligations

ANVISA product registration; labelling in Portuguese; GMP compliance; batch release testing

Penalty Ranges

Refusal of entry; fines up to BRL 1.5M; seizure; criminal prosecution

Mandatory Deadline: Ongoing — registration required before import and sale

Affected HS Codes: 0401, 0402, 0403, 0404, 0405, 0406, 1601, 1602, 1603, 1604, 1605, 2101, 2102, 2103, 2104, 2105, 2106, 2201, 2202, 2203, 2204, 2205, 2206, 2207, 2208, 3001, 3002, 3003, 3004, 3005, 3006, 3301, 3302, 33...

Issuing Authority: National Health Surveillance Agency (ANVISA)