What is an IVD?
Definition​
An in vitro diagnostic device (Produto para Diagnóstico de Uso In Vitro — PDUI) is a reagent, kit, instrument, apparatus, equipment, software or system intended by the manufacturer to be used in vitro for examination of specimens derived from the human body to provide information on physiological or pathological states, congenital disorders, safety and compatibility with potential recipients, or to monitor therapeutic measures.
IVDs in Brazil are regulated under RDC 36/2015 with a separate classification and registration system from other medical devices.
IVD classification overview​
IVDs are classified into four risk-based classes:
| Class | Risk level | Pathway |
|---|---|---|
| Class I | Low | Notificação |
| Class II | Medium-low | Cadastro |
| Class III | Medium-high | Registro |
| Class IV | High | Registro (highest scrutiny) |
See IVD Classification for full details.