ANVISA Brazil Medical Device Registration

The National Health Surveillance Agency (ANVISA) classifies medical devices according to the risk they present. This classification is essential to determine the safety and efficacy requirements that each product must meet. The classification categories are Class I (Low Risk), Class II (Medium Risk), Class III (High Risk) and Class IV (Maximum Risk). Class I and II devices require only notification to ANVISA. With approval, the notification remains in force for an indefinite period. Class III and IV devices require B-GMP certification before a formal registration, with approval the registration is valid for 10 years.

The journey to market medical devices involved comprehensive submissions to ANVISA, including detailed information about the device, clinical data, safety and efficacy studies, among others. This process also includes the marketing approval process and Post-Marketing Surevillance, which involves continous monitoring of the device's performance during its use. Data on adverse events, failures, and patient reactions are collected to ensure the safety, effectiveness, and high quality of medical devices throughout their life cycle.

‍

Local representation is crucial, as it is mandatory to have a company with operating authorization from ANVISA  to commercialize medical devices in Brazil. This authorization is required for processes such as import, export,  manufacturing, distribution, storage, transport, and B-GMP.

‍

Additionally, electromedical equipment must secure INMETRO certification, and devices with  telecommunications features require ANATEL certification, ensuring full compliance with Brazilian  regulations.