IVD Classification (RDC 36/2015)

IVDs are classified under RDC 36/2015 using a separate four-class risk-based system.

IVD classification matrix

Class	Individual risk	Public health risk	Examples
Class I	Low	Low	General chemistry reagents, specimen containers
Class II	Medium	Low–medium	Pregnancy tests, cholesterol tests, urinalysis strips
Class III	Medium–high	Medium–high	HIV confirmatory tests, hepatitis B surface antigen
Class IV	High	High	HIV screening, blood grouping reagents, NAT for blood screening

Classification factors: intended use, risk of false results, technological risk, and population screened.

Registration pathways: Class I → Notificação | Class II → Cadastro | Class III/IV → Registro

• RDC 36/2015

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Official sources

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