Custom-Made & Special Purpose Devices
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 (CBPF), keep records of each device manufactured, and report adverse events via NOTIVISA.
Verify all information against official ANVISA sources before making regulatory decisions.
Custom-made devices are exempt from standard Registro or Notificação filing requirements; however, this exemption does not waive GMP, AFE, adverse event reporting, or post-market surveillance obligations.