Custom-Made & Special Purpose Devices

BR-unique

ANVISA provides a limited exemption from standard registration requirements for devices manufactured specifically for an individual patient, provided strict conditions are met.

A device qualifies as custom-made (sob medida) when it is manufactured specifically for a named individual patient, made to the prescription of a qualified healthcare professional, not manufactured in series, and not intended for supply to anyone other than that named patient.

Even for custom-made devices, manufacturers must hold a valid AFE, comply with GMP requirements, keep records of each device manufactured, and report adverse events via NOTIVISA.

---

Official sources

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