Submission File Elaboration
Notification and Registration of Medical Devices in Brazil
Navigating the regulatory landscape for medical device registration in Brazil can be challenging. This service ensures compliance with ANVISA’s requirements, facilitating smooth market entry. ANVISA, the Brazilian National Health Surveillance Agency, governs the classification and regulation of medical devices.
Devices are classified into four risk classes: I, II, III, and IV. Class I and II devices follow a simpler Notificação (Notification) process, while Class III and IV devices undergo the more rigorous Registro (Registration) process. Understanding these classifications is essential for successful registration.
Foreign manufacturers must appoint a Brazil Registration Holder (BRH). The BRH submits the registration application and maintains regulatory compliance, ensuring efficient market entry. This role is crucial for foreign entities to navigate the local regulatory environment.
Key regulatory documents include RDC 751/2022, which details registration requirements and acceptable documentation languages (Portuguese, Spanish, or English). BGMP certification is mandatory for Class III and IV devices, ensuring adherence to Brazil’s Good Manufacturing Practices. Additionally, INMETRO and ANATEL certifications are required for devices using radio frequency or wireless communication.
Utilizing a BRH offers several benefits. It allows manufacturers to enter the market without establishing a local subsidiary, reducing time and complexity. Moreover, it provides flexibility in changing distributors, as the BRH is an independent entity focused on regulatory compliance.
By leveraging expert guidance and understanding ANVISA’s framework, manufacturers can ensure compliance and successful market entry.
Why do you need this service?
Expert Navigation of ANVISA Regulations:
Sobel’s expertise ensures compliance with complex ANVISA requirements, streamlining the registration process
Quality Management Alignment:
Sobel helps harmonize your quality management systems with Brazilian standards, ensuring seamless market entry and regulatory compliance
Local Representation:
Sobel acts as the Brazil Registration Holder, legally representing foreign manufacturers and handling vigilance issues efficiently
Looking for submission file assistance?
Let us guide you through the process and provide you with the necessary guidance to meet regulatory requirements.
