Brazil ANVISA Health Product Registration

HEADLINE: Unregulated health product imports posed significant risks to Brazilian public health.

Key Obligations

["ANVISA registration mandatory for health products", "GMP compliance for manufacturers", "Annual renewal of registration"]

Penalty Ranges

Import prohibition; fines up to BRL 1,500,000

Affected HS Codes: ["3001", "3002", "3003", "3004", "3005", "3006", "3307", "3401", "3402", "3403", "3404", "3405", "3406", "3407"]

Issuing Authority: National Health Surveillance Agency (ANVISA)

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