Brazil ANVISA Recognized Technical Standards: New Lists for Medical Devices

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-31

On October 22, 2026, Brazil's ANVISA published three new workbooks of recognized technical standards for medical devices. This episode explores the three new lists—transversal standards, orthopedic implantable materials, and health-use materials—and explains how manufacturers can voluntarily use them to create a presumption of conformity with Brazil's essential safety and performance requirements. We discuss how leveraging these standards can streamline the preparation and review of technical documentation, simplifying market access for new and existing products. Key Questions: - What are ANVISA's newly recognized technical standards published on October 22, 2026? - How do these standards relate to Brazil's core medical device regulation, RDC 751/2022? - Wh...