Electronic IFU (eIFU) — ANVISA Position
ANVISA's position on electronic IFU (eIFU) — the delivery of the instructions for use electronically rather than in paper form — is evolving.
As of the date of this site (May 2026), ANVISA has not issued a formal regulation equivalent to the EU's Commission Regulation (EU) No 207/2012 on eIFU for medical devices. However, ANVISA has been consulting on digital health and eIFU topics through its audiências públicas process.
Current practice: Paper IFU in Portuguese is required for all devices. Where a manufacturer wishes to supplement with an eIFU (e.g., via QR code), this may be done provided the paper IFU remains available and complete. ANVISA should be consulted if a manufacturer wishes to provide eIFU only.
Monitor What's New for ANVISA updates on this topic.
Verify all information against official ANVISA sources before making regulatory decisions.