Medical device registration in Brazil
Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). Brazil's base regulations and medical device classification schemes are similar to those found in the European MDD.
We standout
- Local presence and knowlege of regulations
- Medical Device Classification
- Brazil Local Representation
- Regulatory Support to acquire Brazilian Good Manufacturing Process (BGMP) Certification
- Support for Procuring INMETRO Certification
- Document Compilation for Cadastro and Registro Processes
- Post-market Surveillance
How to register for your medical devicein Brazil
For Class I and Class II (Cadastro pathway)
Class I and II device manufacturers must also compile a comprehensive technical dossier for their Brazilian Registration Holder (BRH) to keep on file, along with proposed labeling and IFU, in case of an ANVISA audit. Registration does not expire.
Class III and Class IV (Registro pathway)
Class III and IV device manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional device information.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
