ANVISA Publishes Three Recognized Device Standards Lists

Regulatory Update

On 22 October 2026 (published at 10:56), Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) published Conheça as normas técnicas reconhecidas pela Anvisa para dispositivos médicos, announcing that its portal now provides three workbooks of recognized technical standards prepared by the Gerência-Geral de Tecnologia de Produtos para Saúde (GGTPS). The underlying landing page, Lista de Normas Técnicas Reconhecidas pela Anvisa para Dispositivos Médicos, was first published on 1 September 2026 (09:39) and modified on 8 October 2026 (16:54). Neither page states a separate effective date, transition period, or submission deadline.

When Pure Global covered the initial launch in Brazil ANVISA Publishes List of Recognized Technical Standards for Medical Devices, the landing page linked only version 1.0 of the orthopedic implantable materials workbook (81 entries across ABNT, ISO, and ASTM). The updated page now links three downloadable workbooks:

• Transversal recognized technical standards, version 1.0 (workbook change-log date: 11 September 2026).
• Recognized technical standards for implantable medical devices in orthopedics, version 1.1 (workbook change-log dates: version 1.0 on 1 September 2026; version 1.1 on 3 September 2026).
• Recognized technical standards for health-use materials (materiais de uso em saúde), version 0.0 (workbook change-log date: 10 September 2026).

What the Three Workbooks Cover

Three structural details in the opened workbooks matter directly for regulatory submissions:

1. Exact delta between orthopedic version 1.0 and version 1.1: Cell-by-cell comparison of ANVISA's version 1.0 and version 1.1 orthopedic workbooks confirms that all 27 ABNT rows, all 24 ISO rows, and the first 30 ASTM rows are unchanged in standard identifier, title, and publication year. Version 1.1 reordered the table columns, inserted the Controle de Alteração sheet, and appended seven general ASTM standards (rows 31 to 37 on the ASTM sheet): ASTM F1980 (2021, accelerated aging of sterile barrier systems), ASTM F2503 (2026, marking of medical devices and other items for safety in the magnetic resonance environment), ASTM F2052 (2021, magnetically induced displacement force), ASTM F2213 (2025, magnetically induced torque), ASTM F2182 (2019, radiofrequency-induced heating on or near passive implants), ASTM F2119 (2024, evaluation of MR image artifacts from passive implants), and ASTM F2129 (2025, cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices).
2. Recent editions in the transversal workbook: The transversal workbook lists 2025 or 2026 editions for ABNT NBR ISO 10993-17 (2026), ABNT ISO/TS 10993-19 (2026), ABNT NBR ISO 10993-23 (2025), ABNT ISO/TS 11137-4 (2025), ABNT NBR ISO 11737-3 (2026), ISO 10993-6 (2026), ISO 11137-1 (2025), and ISO/TS 17664-3 (2026). Its single ASTM entry is ASTM F1980 (2021).
3. Duplicate row in the health-use materials workbook: On the ABNT sheet of the health-use materials workbook (version 0.0), ABNT NBR ISO 25539-4 (2024, cardiovascular implants — endovascular devices, Part 4: application of ISO 17327-1 for coated endovascular devices) is listed twice under the cardiovascular implants and extracorporeal systems category, at item 9 and item 11, producing 32 rows for 31 unique ABNT standards.

Scope of Recognition and Compulsory Standards

The landing page keeps the same legal boundaries reported in September:

• Voluntary presumption of conformity, not a compulsory mandate: Use of the recognized standards is voluntary to support demonstration of the general safety and performance requirements in RDC nº 848, de 2024, unless a specific sanitary regulation makes a standard mandatory. The landing page links directly to ANVISA's Normas Compulsórias conforme Regulamento Anvisa subpage (published 15 September 2026), which indexes eight specific regulations that impose compulsory technical standards: RDC nº 549/2021, IN nº 283/2024, RDC nº 539/2021, RDC nº 540/2021, RDC nº 541/2021, RDC nº 550/2021, RDC nº 554/2021, and RDC nº 825/2023.
• Not a marketing authorization: Inclusion of a standard on ANVISA's recognized lists does not constitute product approval, certification, prior authorization, or endorsement, and does not alter the responsibility of the manufacturer or legal representative in Brazil.
• Newer editions permitted before workbook updates: Manufacturers may rely on a more recent edition of a recognized standard even before ANVISA updates the corresponding workbook, including a newer international ISO or IEC edition underlying an ABNT NBR entry that ABNT has not yet revised.

Practical Implications for Manufacturers

Pure Global analysis:

• Map each device dossier to the specific workbook and version: Regulatory affairs teams preparing Brazil medical device registration and notification dossiers can now cite ANVISA's recognized transversal list (version 1.0) across device classes, the expanded orthopedic implantable materials list (version 1.1) — including the newly added MR safety and corrosion ASTM standards — and the health-use materials list (version 0.0) for cardiovascular, ophthalmic, dental, breast, neurological, catheter, contraceptive, and blood-bag/purification devices. Record the workbook name and version label in the essential-requirements checklist.
• Check compulsory-standard regulations before treating a standard as optional: Before treating any standard in the health-use materials or transversal workbooks as purely voluntary, check whether the device category falls under one of the eight compulsory-standard instruments listed on ANVISA's compulsory-standards subpage (such as orthopedic implants under RDC nº 549/2021 and IN nº 283/2024, surgical gloves under RDC nº 547/2021's related instruments, hip/knee/breast implants, needles/syringes/catheters, blood bags, or condoms).
• Document edition differences explicitly: Where testing was conducted to a newer ISO edition than the year printed in ANVISA's workbook, or where an ABNT standard lags its international parent, document that equivalency in the technical file under the landing page's newer-edition rule. Do not count the duplicated ABNT NBR ISO 25539-4 rows (items 9 and 11) as two separate testing requirements.