Brazil - List of Medical Device Technical Standards Recognized by ANVISA

Business description

On September 1, 2026, ANVISA published the list of recognized Technical Standards on medical devices. In specific:

- List of Recognized Cross-Sectoral Technical Standards for Medical Devices (version 1.0)

- Materials for manufacturing implantable medical devices in orthopedics: metallic, ceramic and polymeric materials for implants (version 1.0)

- List of Recognized Technical Standards for Materials Used in Healthcare (version 0.0)

Anvisa has recognized technical standards to improve regulatory predictability, harmonize evaluation criteria, and align with internationally accepted references for medical devices.

These standards support demonstration of compliance with the general safety and performance requirements set out in RDC No. 848/2024. Recognition of a standard does not constitute approval, certification, or endorsement of any specific device.

Use of the recognized standards is voluntary unless otherwise required by regulation.

Source: Brazil - List of Medical Device Technical Standards recognized by ANVISA

Countries:

Brazil

Product categories:

05 Medical Devices

Technical aspects:

Safety

Business fields:

P.05 Medical

Regions:

South-America

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