Clinical Evidence Overview

Clinical evidence by class

Class	Requirement
Class I	Generally not required for Notificação
Class II	Literature-based summary for Cadastro
Class III	Clinical evaluation report
Class IV	Comprehensive clinical evaluation; may require Brazil-specific clinical data

Routes to clinical evidence

1. Systematic literature review — structured search and critical appraisal of published data
2. Substantial equivalence — demonstrating equivalence to a device with documented clinical data
3. Clinical investigation in Brazil — under RDC 10/2015 for novel high-risk devices

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Official sources

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

Class I devices registered via Notificação are generally exempt from pre-market clinical evidence requirements. However, any claims regarding therapeutic efficacy, diagnostic accuracy, or clinical benefit must be supported by published literature or technical justification; purely descriptive claims (e.g., 'sterile surgical gloves') do not require supporting evidence. Class I devices registered via Cadastro or higher pathways should include appropriate clinical justification.

Class I devices registered via Notificação are generally exempt from clinical evidence requirements, though safety-related claims may require supporting data. Class I devices registered via Cadastro or higher pathways should include appropriate clinical justification.