Cadastro — Class II Devices
Cadastro — Class II Devices — ANVISA medical device regulation in Brazil.
IVD Registration Pathway (RDC 36/2015)
IVD Registration Pathway (RDC 36/2015) — ANVISA medical device regulation in Brazil.
Notificação vs. Cadastro vs. Registro
Overview of Brazil's three registration pathways and which applies to each device class.
Notificação — Class I Devices
Notificação — Class I Devices — ANVISA medical device regulation in Brazil.
Peticionamento Eletrônico — ANVISA's Online System
Peticionamento Eletrônico — ANVISA's Online System — ANVISA medical device regulation in Brazil.
Post-Registration Changes (Petição de Alteração)
Post-Registration Changes (Petição de Alteração) — ANVISA medical device regulation in Brazil.
Registration Validity — 10 Years & Renewal
Registration Validity — 10 Years & Renewal — ANVISA medical device regulation in Brazil.
Registro — Class III & IV Devices
Registro — Class III & IV Devices — ANVISA medical device regulation in Brazil.
ANVISA Review Process, Timelines & Appeal
ANVISA Review Process, Timelines & Appeal — ANVISA medical device regulation in Brazil.
Technical File / Dossier Requirements
Technical File / Dossier Requirements — ANVISA medical device regulation in Brazil.