Device Description & Intended Purpose

The device description section of the ANVISA dossier must include: device name (trade/generic/model), intended purpose, indications for use, contraindications and warnings, principle of operation, physical description (dimensions, materials, components), technical specifications, photographs and drawings for all models, and a complete list of variants and accessories.

ANVISA is strict about alignment between the stated intended purpose and the clinical/performance evidence provided. A broad intended purpose claim must be supported by evidence for all the situations covered.

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Official sources

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