Brazil ANVISA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Brazil.
Related services for Brazil:
- Brazil ANVISA Medical Device Registration Holder
- Brazil GMP (B-GMP) Quality System Consulting - RDC 59, RDC 25, RDC 16
- Brazil INMETRO Testing Certification for Medical Devices
- Brazil Medical Device Approval & ANVISA Registration
- Brazilian Medical Device Classification by ANVISA
- Vigilance Reporting for Medical Device Manufacturers in Brazil
Related resources:
- Brazil ANVISA Regulatory Approval Process for IVDs
- Brazil ANVISA Regulatory Approval Process for Medical Devices
- Brazil’s National Health Surveillance Agency
- Medical Device Executive Guide to Brazil
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Manual para Regularização de Produtos para Diagnóstico de uso in vitro | 2016 | ||
| Log in | Manual de Registro e Cadastramento de Materiais de Uso em Saúde | 2011 | ||
| Log in | Cadastro Registration Requirements of Medical Devices | RDC No. 40-2015 | 08/2015 | |
| Log in | GMP Requirements for Medical Devices and IVDs | RDC No. 16-2013 | 03/2013 | English |
| Log in | Registration Requirements of Medical Devices | RDC No. 185-2001 | 2001 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Notification routes for Class I devices and IVDs | RDC No. 270-2019 | 2019 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Rules for Post-approval Modifications | RDC No. 340-2020 | 2020 | |
| Log in | Requirements and procedures of techno-surveillance | RDC No. 67-2009 | 2009 | English |
| Log in | Cadastro registration of IVDs | RDC No. 36-2015 | 2015 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Additional requirements and procedures of techno-surveillance | RDC No. 23-2012 | 2012 | English |
