This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class III/IV) pathways. Exporters will receive essential compliance tips for 2025, focusing on re-classification, technical documentation, labeling in Brazilian Portuguese, B-GMP, and e-labeling provisions to successfully navigate the Brazilian market.

Key Questions:

• What are the four risk classes under Brazil's RDC 751/2022?

• How do the 22 new classification rules impact your medical device?

• What are the key differences between Notification and Registration pathways in Brazil?

• Have you updated your device classification and documentation since March 1, 2023?

• What are the specific requirements for SaMD and nanomaterials under the new Brazilian rules?

• What are the crucial labeling and IFU changes, including language requirements?

• Is your B-GMP certification compliant for Brazilian market access?

• How can you leverage e-labeling options under RDC 751/2022?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.