ANVISA Review Process, Timelines & Appeal

Review stages

Stage	Description	Typical duration
Administrative review	Completeness check	30–60 days
Technical review	ANVISA experts evaluate dossier	Varies by class
Exigências	Deficiency questions — clock stops during response	Within stated deadline
Final decision	Grant or rejection	—
DOU publication	Published in Diário Oficial da União	Shortly after approval

Typical timelines

Class	Typical review time
Class I	Days to weeks
Class II	3–6 months
Class III	12–24 months
Class IV	18–36 months

Appeals (recurso)

If ANVISA rejects a registration, applicant may file a recurso (administrative appeal) within the period stated in the rejection notice (typically 10 working days).

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.