ANVISA Issues IVD and Class I/II Materials Notification Manuals

On 25 August 2026 ANVISA announced two manuals for medical-device regularization:

1. Manual para Regularização de Dispositivos para Diagnóstico in Vitro — Gerência de Produtos para Diagnóstico in Vitro (GEVIT), 84 pages.
2. Manual sobre Regularização de Materiais de Uso em Saúde sujeitos ao regime de Notificação — Gerência de Tecnologia de Materiais de Uso em Saúde (GEMAT), Brasília 2026, 105 pages.

The news page says the materials have orientative character (caráter orientativo) and are addressed to manufacturers, importers, and legal representatives. That phrase is on the news page; it does not appear in the PDF bodies. Neither document is a new RDC. They tell companies how ANVISA expects petitions under rules that already exist: RDC 830/2023 for IVDs, RDC 751/2022 for class I/II materials under notification.

They are not the December 2025 Manual para Registro de Materiais de Uso em Saúde (registro of higher-risk materials), and they are not the GQUIP equipment and software-as-medical-device manual.

Both files sit in ANVISA’s Manuais, guias e orientações folder. Bare .pdf URLs on that site often open an HTML viewer; the @@download/file links above return the files.

What the IVD manual actually instructs

The IVD introduction states that notification or registro of IVDs is governed by RDC 830 of 6 December 2023, with complementary norms. A petition is a documentary process that GEVIT’s technical staff will decide, including by issuing technical requirements where needed.

Three clocks in §1.1.1 are easy to mix up:

• Registro is valid for 10 years from publication of the grant in the Diário Oficial da União (DOU). Revalidation must be filed at most 12 months and at least 6 months before expiry. Once granted, the new 10-year period runs from the expiry date of the previous registro, not from the revalidation publication date.
• Notificação has indeterminate validity and is not revalidated.

A petition filed without a required document is summarily refused. The manual says that situation does not generate a technical exigência. It cites RDC 204/2005, Article 2(2)(II), and RDC 830/2023, Article 11(4): a document that needs clarification can generate an exigência; a document that was not sent generates summary refusal.

The table of contents is a map of the rest of the file: company regularization (AFE, licence, good manufacturing practices), risk class, unique product versus family, prior-analysis products, Solicita petitioning, the technical dossier, families (with a chapter on frequent families, including reagents, calibrators and controls), and secondary petitions (change, revalidation, addendum, transfer of ownership, IFU upload, administrative appeal, reclassification from notification to registro, and others). This article does not reproduce those chapters.

What the class I/II notification manual actually instructs

GEMAT’s objective statement is to guide manufacturers, importers, distributors, and other regulated persons on notification of class I and II materials for health use under RDC 751/2022.

Chapter I restates RDC 751: class I (low risk) and class II (medium risk) are exclusively under notification and are exempt from registro (Law 6.360/1976, Article 25(1); RDC 751, Article 6).

RDC 751, Article 10(5), as quoted in the manual, says there is no technical analysis of notification and notification-change petitions for products to be considered regularized. That is without prejudice to documentary or inspection review at any time, or to requests for further information or clarification. The manual adds that submitted files can be audited before or after notification.

If an audit of the notification file finds missing, incomplete, illegible or obsolete instruction documents, a missing conformity certificate where one is required, or missing evidence of safety and efficacy, the petition is summarily refused (Article 10(4)). Complementary documents for technical clarification are, according to the manual, available only in processual re-evaluation.

Other clocks in the same chapter:

• notification is processed routinely within 30 days of protocol (Article 10(6)), and the grant is published in the DOU;
• failure to answer a notificação de adequação within 30 days of its issue leads to cancellation of the notification or of the alteration (Article 38(3)).

Immediately before the processing flowchart, GEMAT lists errors it says the technical area “always” sees: incomplete mandatory documents; missing mandatory documents; forms without electronic signatures; incorrect regulatory classification.

What these manuals are not

The 25 August news presents the manuals as part of a project to improve incoming files and reduce technical requirements, refusals, and analysis queues. That is ANVISA’s stated aim. The PDFs do not report a measured change in queue length or a new statutory deadline. Do not read them as a promise of faster grants.

They do not amend or replace RDC 830 or RDC 751. Applicants should use the orientation manuals together with the current resolutions, petition subject list, forms, and portal checklists.

The earlier Regulatory Update on Solicita subject 80326 is a different event: a petition subject for foreign-manufacturer data, not these two manuals.

What companies should do with the files

1. Use the IVD manual when building or checking an RDC 830 petition — especially the distinction between missing documents (summary refusal) and incomplete documents (possible exigência), and the 10-year registro versus open-ended notification clocks.
2. Use the GEMAT manual for class I/II notification petitions — especially Article 10(5) (no technical analysis) together with the audit and summary-refusal rules, the 30-day processing expectation, and the 30-day clock on adequacy notices.
3. Do not treat either PDF as a substitute for the RDC, the current Solicita subject list, or the notification form.
4. Keep class I/II notification work separate from class III/IV registro and from the GQUIP equipment/SaMD path.

Brazilian market-access context is on Pure Global’s Brazil page. The manuals themselves are the two download links above.