Instructions for Use (IFU)
The document that tells patients or clinicians how to use a medical device or product.
What it means
Instructions for Use (IFU) is the document that provides directions for the safe and effective use of a medical device, diagnostic, or product. For regulatory submissions in Latin America, IFUs must be translated into the local language and formatted to match the source, including warnings, contraindications, and device diagrams.
Why it matters for LATAM submissions
IFUs are high-risk documents because they contain safety-critical instructions. A mistranslated warning or incorrect unit of measurement can trigger a regulator query or recall.
Relevant regulators
Related terms
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