Market access LATAM
Brazil is the largest medical device market in LATAM, with an established and complex regulatory and compliance system. National Health Surveillance Agency (ANVISA) is responsible for the surveillance of medical devices.
What institution is responsible for the regulation and supervision of medical devices in Brazil?
ANVISA is the authority responsible for medical devices in Brazil. ANVISA is responsible for laws on medical devices, medical device authorizations, monitoring of manufacturers’ quality management systems to ensure compliance with the Brazilian requirements.
How are medical devices classified in Brazil?
Registration medical devices in Brazil requires to determine a risk class. ANVISA differentiates between four classes: from class I (low risk) to IV (high risk).
Annex II of RDC-185/2001 establish 18 rules of classification.
To establish a class you can use the table:
| European Union (2017/745) | Brazil (RDC-185/2001) |
|---|---|
| I | I |
| IIa | II |
| IIb | III |
| III | IV |
What is the registration of medical devices in Brazil?
Registration in ANVISA differentiates two different registration paths in accordance to the classification:
Class I and II devices are notified to ANVISA to obtain a notification number.
Class III and IV devices require a complete authorization and testing procedure.
How can we help?
MDR Regulator will assist your company in complying with regulatory requirements in Brazil. We will prepare the required documents, analyse the registration procedures, check the technical documentation and perform the registration at ANVISA.