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 denies a registration application, the applicant may file a recurso (administrative appeal) within the timeframe specified in the formal rejection notice. The appeal period is typically 10 working days from receipt of the rejection. The applicant should address the specific deficiencies or concerns cited by ANVISA in the appeal submission.

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Official sources

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