IVD risk classification in Brazil: why RDC 830 class decides the rest

Many companies start their IVD entry into Brazil with the dossier, the validation plan or the choice of distributor. The question that should come before all of these is simpler: which class does the product fall into? IVD risk classification in Brazil, as set out in RDC 830/2023, decides whether the route is notification or registration, whether an ANVISA Good Manufacturing Practice certificate (CBPF) is required, how deep the dossier must go and whether reliance is an option. In other words, it decides the timeline and cost of the entire market entry.

This article explains the four classes, shows where the rules sit and points out the classification mistakes that most often delay projects.

Four classes, two regulatory routes

RDC 830/2023 has been in force since 1 June 2024 and repealed RDC 36/2015. It sorts in vitro diagnostic medical devices into four risk classes, I to IV (arts. 5 to 8). Classes I and II follow the notification route (art. 6); classes III and IV follow the registration route (art. 7).

The table summarises what changes from one end to the other.

Class	Route	Technical dossier	ANVISA CBPF	Reliance (IN 290/2024)	Renewal
I	Notification	Kept by the company, not submitted (art. 57, §1)	Not required	Not applicable	Exempt (art. 28)
II	Notification	Submitted, with the information required for the class (art. 13)	Not required	Not applicable	Exempt (art. 28)
III	Registration	Full (Chapter VII and Annex II)	Required (art. 14, VIII)	Possible for initial registration	Every 10 years (art. 12)
IV	Registration	Full (Chapter VII and Annex II)	Required (art. 14, VIII)	Possible for initial registration	Every 10 years (art. 12)

Between class II and class III there is an entire regulatory step. It is not simply “more paperwork”: it is a different route, with a factory certificate and a technical review of a full dossier.

Where the rules are: Annex I of RDC 830 itself

The classification rules are in Annex I of RDC 830/2023. There is no separate normative instruction for classifying IVDs. The normative instructions linked to RDC 830 deal with other matters: product families (IN 320/2024), changes (IN 74/2020) and reliance (IN 290/2024).

The starting point is art. 9: the application of the classification rules is governed by the device’s intended purpose. Not the technology, not the price, and not the class the product holds in another country. The same article states that, when several rules apply to the same product, the one leading to the highest class prevails (art. 9, §4).

Annex I contains eight rules. Some examples of what they say:

• Rule 1 (class IV): detecting the presence of, or exposure to, a transmissible agent in blood and blood components to determine suitability for transfusion or transplantation; and detecting a transmissible agent that causes a potentially life-threatening disease with a high or presumed high risk of propagation.
• Rule 2: blood grouping. The rule places products for the ABO, Rhesus, Kell, Kidd and Duffy systems in class IV.
• Rule 3 (class III): covers, among other purposes, sexually transmitted agents, infectious diseases where an erroneous result creates a significant risk of death, human genetic testing, certain cancer-related purposes and companion diagnostics for therapy selection.
• Rule 4 (self-testing): class III, except where the result does not determine a critical medical status, in which case the product is class II.
• Rule 5 (class I): buffer solutions, diluents, ready-to-use culture media and materials for collecting, containing and preserving specimens, among others.
• Rule 6 (class II): the residual rule for anything not covered by the previous rules.
• Rule 8: products for notifiable diseases fall into class III, unless another rule already places them in class IV.

These examples are summaries. What counts is the full text of the rule, applied to your product’s exact intended purpose.

The official list of technical names that changed class

When RDC 830 came into force, some IVD technical names moved to a different class compared with the previous rules. ANVISA published an official list of these reclassified technical names, currently in version 4.

The list matters in two situations. The first is a company with a product authorised before June 2024 that needs to know whether its current classification still holds. The second is a company planning a new product and using, as a benchmark, a competitor registered under the old regulation. In both cases, the “old” class may no longer apply.

What the class decides in practice

CBPF

The CBPF issued by ANVISA is required only for registration, that is, for classes III and IV (art. 14, VIII). Proof that the certification request has been filed is enough to submit the application, but registration is granted only once the CBPF has been published. Under notification (classes I and II), no CBPF is required.

For a manufacturer, this reshapes the whole timeline: in classes III and IV, factory certification runs in parallel with the dossier and may become the critical path.

Dossier and validation

For class I, the technical dossier is not submitted to ANVISA, but the company must keep it for health surveillance purposes. For class II, the dossier is submitted with the information required for that class. For classes III and IV, the dossier is complete and includes the performance studies listed in Annex II: trueness, precision (repeatability and reproducibility), analytical sensitivity and specificity, prozone effect, measuring interval, and clinical sensitivity and specificity, where applicable.

A validation plan designed for the wrong class creates one of two problems: missing studies, which turn into a deficiency letter, or unnecessary studies, which consume months for no benefit.

Reliance

Reliance under IN 290/2024 applies only to the initial registration of class III and IV products already approved by one of the reference authorities: TGA (Australia), Health Canada, FDA (510(k), PMA or De Novo) and MHLW (Japan). CE marking does not qualify. Reliance speeds up the technical review, but it does not change the product’s place in the queue and does not waive the CBPF.

Timeline

An ABIIS study released in February 2026, covering July 2024 to June 2025, reported an average of around 200 days for ANVISA’s review of IVDs, without separating classes III and IV. That figure describes the review only. The total time to market also depends on the CBPF, dossier preparation and the quality of any response to a deficiency letter, and all of these depend on the class.

Common classification mistakes

In consulting work and in day-to-day laboratory practice, a few mistakes come up again and again:

1. Classifying by technology rather than purpose. A PCR assay can fall into different classes depending on the analyte, the population and how the result is used. The rules look at what the product claims, not at how it works.
2. Stopping at the first rule that fits. Art. 9 requires all rules to be considered and the highest class to be kept. A product that looks like class II under the residual rule may end up in class III because it is a self-test or because it detects the agent of a notifiable disease.
3. Writing the intended purpose too broadly. Generic wording in the instructions for use, such as “aid to diagnosis” without defining population and context, can trigger stricter rules than the product actually needs.
4. Copying the class from another market. The class assigned in the European Union, the United States or elsewhere does not carry over automatically. Classification in Brazil follows the rules in Annex I of RDC 830.
5. Relying on RDC 36/2015. That regulation has been repealed. Classifications based on it, including in older internal documents, need to be reviewed.

How to reach the right class with confidence

The route we recommend is short and documented:

1. Write the complete intended purpose: analyte, specimen type, population, user (professional or lay person) and how the result will be used.
2. Go through the eight rules in Annex I one by one and record which apply.
3. Keep the highest class among the applicable rules.
4. Check the technical name against the official list of reclassified names.
5. Keep the rationale in writing. It guides the validation plan, the CBPF application and the reliance strategy, and it helps when answering a deficiency letter.

Only then does it make sense to budget the validation, choose the route and build the timeline.

Next step: confirm the class before investing in the dossier

For a quick first reading of what your product needs to enter Brazil, try ANVISA Readiness, one of our free tools (currently available in Portuguese only).

If the decision involves investment, timelines and choice of partners, the Go-to-Brazil Program delivers a complete market entry assessment in 6 to 10 weeks: regulatory, technical and commercial gaps, with an entry plan, timeline and next steps. To discuss your case, get in touch.

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Sources

• ANVISA — RDC 830/2023 (LegisWeb) (Portuguese)
• ANVISA — RDC 830/2023: technical names reclassified (version 4) (Portuguese)
• ANVISA — Questions and answers on RDC 830/2023 (Portuguese)
• ANVISA — IN 290/2024 (reliance) (Portuguese)
• CBDL — ABIIS study on ANVISA review times for medical devices (Portuguese)