Key Roles and Responsibilities
Domestic manufacturers
Domestic manufacturers must hold a valid AFE, register their products with ANVISA (Class I–IV pathway), comply with GMP/CBPF requirements (RDC 752/2022), appoint a Responsável Técnico, report adverse events via NOTIVISA, and maintain a post-market surveillance system.
Importers
In Brazil, the importer typically holds the product registration (Registro/Cadastro/Notificação) in their own name — not the foreign manufacturer. This means the importer is legally responsible for the product's compliance throughout its lifecycle in Brazil.
Importers must hold a valid AFE, hold the product registration, appoint a Responsável Técnico, verify the foreign manufacturer's GMP certificate, and report adverse events.
Responsável Técnico (RT)
The Responsável Técnico (RT) is a legally mandated role unique to Brazilian health surveillance law. Every company that manufactures, imports, or distributes medical devices must appoint an RT registered with the relevant professional council (CRM, CRF, CREA, etc.).
The RT is personally responsible for technical decisions about product quality and compliance, signing ANVISA submissions, ensuring NOTIVISA reports are submitted, and representing the company in ANVISA inspections.
Distributors & wholesalers
Distributors must hold their own AFE for distribution activities and comply with storage, transport and recall obligations. They are also required to report adverse events they become aware of via NOTIVISA.
Healthcare facilities
Hospitals, clinics and laboratories are classified as user facilities and must report serious adverse events to NOTIVISA.