ANVISA Publishes List of Recognized Technical Standards for Medical Devices in September 2026: Conformity Evidence Can Reduce Technical Justification, But Recognition Is Not Approval

Published: October 10, 2026, 19:32 | Category: Registration and Market Access

On September 1, 2026, the Brazilian Health Regulatory Agency (ANVISA) published a page titled "List of Technical Standards Recognized by ANVISA for Medical Devices" on its official website. The page was last updated on October 8, 2026. It states that compliance with ANVISA-recognized technical standards can reduce additional technical justification in the technical dossier for the corresponding aspects, provided three conditions are met: the standard is applicable to the device under evaluation; the use of the standard is reasonably justified; and objective conformity evidence is submitted. The use of standards is generally voluntary, with a separate entry for mandatory standards. ANVISA emphasizes that recognition does not constitute approval, certification, prior authorization, or endorsement of a specific device, and the responsibility for demonstrating compliance remains with the manufacturer or its legal representative. The page does not establish any new compliance deadlines.

Sources

• Agência Nacional de Vigilância Sanitária (ANVISA) — Lista de Normas Técnicas Reconhecidas pela Anvisa para Dispositivos Médicos: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/lista-de-normas-tecnicas-reconhecidas (2026-09-01)
• Agência Nacional de Vigilância Sanitária (ANVISA) — Normas compulsórias conforme regulamento Anvisa: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/lista-de-normas-tecnicas-reconhecidas/normas-compulsorias-conforme-regulamento-anvisa
• Agência Nacional de Vigilância Sanitária (ANVISA) — RDC nº 848, de 6 de março de 2024 (essential safety and performance requirements): https://www.gov.br/anvisa/en/rules-and-regulations/arquivos/rdc-848-2024-e.pdf/@@display-file/file (2024-03-06)

An Explanatory Page Published in September 2026

On September 1, 2026, ANVISA published the page "List of Technical Standards Recognized by ANVISA for Medical Devices" on its official website, last updated on October 8, 2026. The page explains that the purpose of recognizing technical standards is to enhance regulatory predictability, harmonize assessment criteria, and adopt internationally accepted technical references in the medical device registration (regularização) process. These standards help demonstrate that products comply with the general safety and performance requirements set out in Collegiate Board Resolution No. 848 of 2024 (RDC 848/2024).

Recognition Is Not Approval

The page states clearly: ANVISA's recognition of a technical standard does not constitute approval, certification, prior authorization, or any form of endorsement of a specific medical device. The responsibility for demonstrating compliance with applicable regulatory requirements remains entirely with the manufacturer or its legal representative. The use of recognized standards also does not exempt companies from ensuring that the device meets all relevant regulatory requirements. In other words, standards are evidence tools, not marketing authorizations.

What Can Be Reduced by Using Recognized Standards

When preparing the technical dossier (Dossiê Técnico) and conducting risk management, companies should first identify the technical standards applicable to the product. Compliance with a recognized standard can reduce additional technical justification for the aspects covered by that standard; however, for this to hold, three conditions must be met simultaneously:

• The standard is applicable to the device under evaluation;
• There is a reasonable justification for using the standard;
• Objective conformity evidence is submitted, such as test reports, certificates, validation records, and other appropriate technical documentation.

Recognition itself does not prove that a given device meets the standard or all regulatory requirements.

Current Three Lists and the Voluntary Principle

The page states that the use of standards on the list is generally voluntary, unless otherwise mandated by applicable health regulations (a separate entry on the page covers "Standards Mandatory under ANVISA Regulations"). Companies may also use alternative approaches, provided they submit sufficient technical and scientific justification demonstrating that the level of evidence is equivalent to or higher than that of the recognized standard, or is more appropriate due to the nature of the product, technology, or specific characteristics. As of the verification date, three lists were publicly available:

• Medical Device Horizontal Recognized Technical Standards (Version 1.0)
• Orthopedic Implant Materials Recognized Technical Standards (Version 1.1)
• Medical Materials Recognized Technical Standards (Version 0.0)

The page also mentions that specific lists may be published for particular product categories when necessary.

What If a New Version of a Standard Is Issued?

ANVISA states that it will periodically review and update the lists based on the publication of new versions or revisions of standards, the evolution of device technology, accumulated regulatory experience, alignment with international regulatory practices and references, and the need to add, remove, or modify standards. Updates will be published on that page along with a revision history. If a standard on the list is superseded by an updated version, the new version may be used directly even if the page has not yet been synchronized. For standards from the Brazilian Association of Technical Standards (ABNT) that are based on international reference standards, if ABNT has not yet revised its version, ANVISA takes the same approach.

Are There Any New Deadlines?

The page does not set any new compliance deadlines or transition periods. It clarifies how evidence from recognized standards can be used under the existing framework; it is an explanatory note and does not introduce new regulatory requirements. RDC 848/2024 itself was published on March 6, 2024. It should be noted that the "reduction of additional justification" mentioned on the page applies to the aspects covered by the standard; for requirements outside that coverage, companies must still provide separate evidence.

Sources and Applicability Notes

Source: Based on the ANVISA webpage "Lista de Normas Técnicas Reconhecidas pela Anvisa para Dispositivos Médicos" (published September 1, 2026; updated October 8, 2026). Original text: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/lista-de-normas-tecnicas-reconhecidas

Also checked the ANVISA page "Normas compulsórias conforme regulamento Anvisa": https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/lista-de-normas-tecnicas-reconhecidas/normas-compulsorias-conforme-regulamento-anvisa

And the English version of RDC 848/2024 (published March 6, 2024): https://www.gov.br/anvisa/en/rules-and-regulations/arquivos/rdc-848-2024-e.pdf/@@display-file/file

Verification scope and access date: The above pages were accessed on October 10, 2026, to verify the publication and update dates, the composition and version numbers of the three lists, the voluntary use principle, the three conditions for conformity evidence, alternative approaches and version update rules, and whether any new deadlines exist.

Applicability note: This article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. The official original text prevails; information may change with subsequent official updates.

Information Sources

• Agência Nacional de Vigilância Sanitária (ANVISA) — Lista de Normas Técnicas Reconhecidas pela Anvisa para Dispositivos Médicos (2026-09-01)
• Agência Nacional de Vigilância Sanitária (ANVISA) — Normas compulsórias conforme regulamento Anvisa
• Agência Nacional de Vigilância Sanitária (ANVISA) — RDC nº 848, de 6 de março de 2024 (essential safety and performance requirements) (2024-03-06)

AIMEILI Regulatory Interpretation and Business Impact

For global medical device manufacturers, distributors, CROs, and regulatory affairs teams, this ANVISA update is primarily a clarification of existing practice rather than a new regulatory hurdle. The key takeaway is that recognized technical standards can serve as efficient evidence tools to reduce the need for extensive additional technical justification in the Brazilian technical dossier—provided that the three conditions are rigorously met. This can potentially streamline submissions and reduce documentation burden, but it does not lower the overall compliance bar under RDC 848/2024.

Business impact:

• Opportunity for efficiency: Companies already using internationally recognized standards (e.g., ISO, IEC) may find it easier to leverage existing test reports and certificates for ANVISA submissions, potentially accelerating time to market if the standards are on ANVISA's recognized lists.
• No automatic approval: Recognition of a standard is not device approval. Manufacturers must still demonstrate full compliance with all applicable regulatory requirements. The responsibility remains with the manufacturer or its legal representative.
• Documentation strategy: Regulatory teams should map their device's applicable standards against ANVISA's three lists, document the justification for using each standard, and ensure objective conformity evidence is readily available. For aspects not covered by a recognized standard, separate evidence is still required.
• Mandatory standards: Companies must check the separate list of mandatory standards under ANVISA regulations. For those, compliance is not optional.
• Version control: Since new versions of standards can be used directly even before the ANVISA list is updated, companies should monitor both ANVISA updates and standards development organizations (e.g., ABNT, ISO, IEC) to ensure they are using the most current and appropriate version.
• No transition period: There are no new deadlines, so existing timelines and requirements remain in force. Companies should continue to comply with RDC 848/2024 and any other applicable regulations.

AIMEILI recommends that manufacturers and their regulatory partners conduct a gap analysis of their current technical dossiers to identify where recognized standards can be leveraged, and to ensure that justifications and evidence are robust. Distributors and CROs can use this clarification to advise clients on optimizing their ANVISA registration strategies while maintaining full compliance.