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 requires strict alignment between the stated intended purpose and the clinical/performance evidence provided. Broad intended purpose claims (e.g., "for use in all patient populations") must be supported by evidence demonstrating safety and performance across all claimed populations, indications, age groups, and clinical contexts. Overly broad claims that exceed supporting evidence will result in Requests for Additional Information (RAI), approval delays, or restriction of the approved intended use to populations/indications where evidence exists. Conversely, narrowing the intended use post-approval typically requires a modification dossier.
Verify all information against official ANVISA sources before making regulatory decisions.