Brazil Medical Device Registration

Brazil Medical Device Registration with Qserve

Streamlined Support for Compliance

Navigating Brazil’s medical device registration process can be challenging, whether Brazil is your first market or part of a broader global strategy. At Qserve, we simplify this process, ensuring compliance with ANVISA RDC 751/2022 while minimizing your time to market.

How Qserve Supports Brazil Medical Device Registration

• Qserve helps you prepare and submit the technical documentation required for ANVISA approval. If you already have documentation from other markets, such as the EU or the US, we conduct a comprehensive gap analysis to identify overlaps and missing elements.

• We analyze your existing materials, compare them with Brazil-specific requirements, and address the differences to ensure your submission meets ANVISA standards.

• With a Brazilian expert on our team, we ensure smooth communication with ANVISA and guide you through the regulatory process efficiently and accurately.

• For foreign manufacturers, we facilitate the appointment of a Brazilian Registration Holder (BRH), who manages compliance and serves as your local point of contact with ANVISA.

• Beyond registration, Qserve supports the maintenance of registered products, including renewals, modifications, and compliance updates, ensuring your devices remain market-ready.