Brazil: ANVISA Clarifies Use of Recognized Medical Device Standards

Brazil’s National Health Surveillance Agency (ANVISA) published guidance on recognized technical standards on 1 September 2026, explaining how they can support medical device safety and performance evidence under RDC No. 848/2024.

The publication clarifies evidence preparation. Recognition does not constitute product approval, certification, prior authorization, or endorsement. Manufacturers or their legal representatives remain responsible for demonstrating compliance with all applicable requirements.

Check the scope of the published list

As reviewed on 10 September 2026, the page links to a version 1.0 list for materials used in orthopedic implants, covering metallic, ceramic, and polymeric materials. The page’s broader discussion of biocompatibility, sterilization, process validation, mechanical performance, and electromagnetic compatibility should not be read as recognition of every standard in those areas.

What belongs in the technical dossier?

ANVISA says compliance with a recognized standard may reduce additional technical justification for the aspects it covers, provided the manufacturer:

• Confirms that the standard applies to the device;
• Adequately justifies its use; and
• Supplies objective evidence, such as test reports, certificates, validation records, or other appropriate technical documentation.

These conditions also matter when identifying standards for risk management. Recognition alone does not establish that a particular device meets the standard or all regulatory requirements.

Voluntary use and newer editions

Use of recognized standards is generally voluntary, unless an applicable sanitary regulation specifies otherwise. Manufacturers may use alternative methods with sufficient technical and scientific justification showing an equivalent or higher level of evidence, or better suitability for the device’s nature, technology, or specific characteristics.

ANVISA will periodically review the lists. When a listed standard is replaced by an updated edition, that edition may be used before the list is revised. The agency extends the same approach to updated international reference standards underlying Brazilian Association of Technical Standards (ABNT) standards where ABNT has not yet revised its version. The page specifies no new compliance deadline.

Practical implications for manufacturers

Pure Global’s analysis: Before relying on recognition in a Brazilian dossier, check the actual list entry and its applicability, connect each supporting report to the requirements it addresses, and identify requirements that still need separate evidence. This helps distinguish a recognized reference from a complete compliance case. For broader market access requirements, see our Brazil medical device regulatory guide.