Class I · II · III · IV — Overview

Class I — Low risk | Pathway: Notificação

Largely administrative process — no detailed pre-market ANVISA technical review before market placement. Examples: Tongue depressors, non-sterile gauze, examination gloves, cold/hot packs.

Class II — Medium-low risk | Pathway: Cadastro

Abbreviated technical documentation + ANVISA simplified review (3–6 months). Examples: Single-use syringes, sterile examination gloves, manual wheelchairs, manual blood pressure monitors.

Class III — Medium-high risk | Pathway: Registro

Full technical dossier + ANVISA technical review (12–24 months). Examples: Digital X-ray systems, powered wheelchairs, anaesthesia machines, haemodialysis equipment, CT scanners.

Class IV — High risk | Pathway: Registro (highest scrutiny)

Most stringent pathway — substantial clinical evidence and thorough ANVISA review (18–36 months). Examples: Pacemakers, implantable defibrillators, heart valves, drug-eluting stents, cochlear implants.

All registrations are valid for 10 years.

IVDs — separate classification under RDC 36/2015

See IVD Classification.

Class I — Low risk | Pathway: Notificação​

Class II — Medium-low risk | Pathway: Cadastro​

Class III — Medium-high risk | Pathway: Registro​

Class IV — High risk | Pathway: Registro (highest scrutiny)​

IVDs — separate classification under RDC 36/2015​

Class I — Low risk | Pathway: Notificação

Class II — Medium-low risk | Pathway: Cadastro

Class III — Medium-high risk | Pathway: Registro

Class IV — High risk | Pathway: Registro (highest scrutiny)

IVDs — separate classification under RDC 36/2015