| Medical device | Produto para saúde / Produto médico | RDC 751/2022 |
| In vitro diagnostic | Produto para Diagnóstico de Uso In Vitro (PDUI) | RDC 36/2015 |
| Registration | Registro | Required for Class III and IV |
| Cadastre / Listing | Cadastro | Required for Class II |
| Notification | Notificação | Required for Class I |
| Good Manufacturing Practices | Boas Práticas de Fabricação (BPF/GMP) | RDC 752/2022 |
| GMP Certificate | Certificado de Boas Práticas de Fabricação (CBPF) | Issued by ANVISA or state VISA |
| Technical Responsible | Responsável Técnico (RT) | Legally mandatory; registered with professional council |
| Legal Representative | Responsável Legal | Company's legal representative |
| Establishment Operating Authorisation | Autorização de Funcionamento de Empresa (AFE) | Required for all economic operators |
| Operating Licence | Licença de Funcionamento | Municipal-level licence |
| Adverse event | Evento adverso | Any unintended harmful event |
| Technical complaint | Queixa técnica | Device malfunction without harm |
| Tecnovigilância | Tecnovigilância | ANVISA's post-market device surveillance program |
| Adverse event reporting system | NOTIVISA | Online portal for adverse event reports |
| Recall | Recolhimento | Removal of unsafe devices from market |
| Seizure / Interdiction | Interdição / Apreensão | ANVISA/VISA enforcement action |
| Electronic petitioning system | Peticionamento Eletrônico | ANVISA's online submission portal |
| Post-registration change | Petição de Alteração | Application to modify a registered product |
| Infraction notice | Auto de Infração | Formal enforcement notice |
| Fine | Multa | Financial penalty |
| Registration cancellation | Cancelamento de Registro | ANVISA-ordered removal of registration |
| Free Sale Certificate | Certificado de Exportação (CFG) | Document proving product is legally sold in Brazil |
| Instructions for use | Instruções de Uso (IFU) | Must be in Portuguese |
| Label | Rotulagem | Brazilian-Portuguese labelling required |
| Classification enquiry | Consulta de enquadramento | Formal classification opinion from ANVISA |
| Public hearing / consultation | Audiência Pública / Consulta Pública | ANVISA's regulatory consultation process |
| National Surveillance System | Sistema Nacional de Vigilância Sanitária (SNVS) | Federal + state + municipal surveillance |
| MERCOSUL | MERCOSUL / Mercosur | South American customs union |
| GMC Resolution | Resolução GMC | MERCOSUL harmonised resolution |
| ABNT Standard | Norma ABNT NBR | Brazilian national standard (adapted from ISO/IEC) |
| Essential requirements | Requisitos Essenciais | Safety & performance requirements |
| Risk management | Gestão de Riscos | ISO 14971 in Brazil context |
| Combination product | Produto Combinado | Device + drug or biologic |