Leveraging Medical Device CE Marking for Faster Entry into Brazil

Regulatory submissions often include many of the same pieces, like device descriptions, risk analyses, and test reports, just presented in different ways. Once you’ve obtained approval in a major market like the US or EU, much of that work can be repurposed, especially as more regulators harmonize with international frameworks (such as the EU MDR, IMDRF, ASEAN, etc.). For example, in Brazil, existing approval under the EU Medical Devices Regulation (MDR 2017/745) can give you a significant head start preparing your ANVISA submission.

How Brazil’s Regulatory Framework Mirrors the EU

Brazil is no longer an emerging market. It imported over $9.33 billion in medical technologies in 2024 alone, an 18% increase from 2023. Opaque requirements and a reputation for meticulous review has made Brazil an intimidating target, even for companies familiar with the regulatory process. But ANVISA has been busy integrating international concepts, which is starting to pay off with a more streamlined process. For example:

Annexed classification rules from EU MDR
RDC 751/2022 adopted the 22 classification rules in the EU MDR (Annex VIII), which means many devices categorized under EU rules will map into similar risk classes in Brazil. Class I and II devices typically follow the Notification route, which involves minimal pre-market review by ANVISA, usually within 30 days. Class III and IV devices must complete the full Registration process, which includes a detailed technical review by ANVISA and Brazil GMP compliance.

Aligned Essential Safety and Performance Requirements
RDC 848/2024 aligns Brazil’s essential safety and performance requirements with international norms by drawing directly from IMDRF guidance. While not identical to the MDR’s General Safety and Performance Requirements (GSPRs), RDC 848/2024 reflects EU principles around lifecycle safety, risk management, performance validation, and software.  

Technical dossier structure
The format of the Brazilian technical dossier under RDC 751/2022 is similar to IMDRF and MDR Technical Documentation formats. Brazil has also adopted a “table of contents” (i.e., required documents and information, and sequence in which they should be presented) consistent with international norms.  

Quality management system (QMS) compliance via MDSAP and ISO 13485
For Brazil’s higher‑risk devices (Class III/IV), your manufacturing site must hold B‑GMP certification (Brazilian GMP). B-GMP is harmonized with ISO 13485, so if your manufacturing site meets the standard’s requirements, you are well on your way to B-GMP compliance (though an ANVISA inspection may still be necessary). ANVISA does accept Medical Device Single Audit Program (MDSAP) certification (if the audit scope includes Brazil’s requirements), which exempts the on-site inspection requirement.

Labeling and UDI
Brazil has adopted UDI-DI requirements and labeling standards in line with EU MDR/IVDR and IMDRF guidance. That means CE-compliant labeling is already close to Brazilian requirements, with localization (Portuguese) being the main difference.

Next steps to be ready for ANVISA submission

These similarities do not mean automatic approval, but they do mean 70-80% of your CE documentation can be repurposed. However, a few more boxes need to be checked before you can submit to ANVISA:

• Local certification requirements: Medical electrical equipment as well as certain other types of devices (e.g., surgical gloves, breast implants, and more) require INMETRO certification, while devices with wireless communication, Bluetooth, or cellular components often require ANATEL certification. If your device requires these certifications, they must be obtained from an accredited body before submitting to ANVISA.  

• Portuguese translations: ANVISA requires most elements of the regulatory submission (i.e., labeling, instructions for use (IFU), risk classification forms, and device descriptions) to be provided in Brazilian Portuguese.  

• Brazil license holder requirement: Brazil requires that all medical device submissions be filed and maintained by a Brazilian Registration Holder (BRH) or license holder, a local legal entity authorized to represent manufacturers to ANVISA.  

Your ANVISA Notification ready in half the time

With Brazil’s device market growing 18% last year, timing matters more than ever. If you’ve already done the work to secure CE Marking, Pure Global can use proprietary AI to turn that dossier into an ANVISA Notification within a week, while our in-house team manages all the local requirements. We submit your Notification as your official Brazil license holder, with a flat annual fee that covers dossier preparation, submission, importation letters, and lifecycle updates. ANVISA Notifications are now faster and simpler. Learn more about AI-Supported ANVISA Submissions.

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