Entering Brazil with a Molecular Diagnostic Product: Where to Start?

An introductory guide for manufacturers and biotechs who want to understand the path before taking the first step.

Brazil is big — but getting in the wrong way is expensive

If you have a molecular diagnostic product and are thinking about entering the Brazilian market, you have probably heard that Brazil is the largest diagnostics market in Latin America. That is true. What is not always said is that entering it without a plan is one of the most efficient ways to waste time and money in healthcare.

This article is for those at the start of that journey: you have not submitted anything to ANVISA yet, you have no distributor in Brazil, and you want to understand — clearly and without excess jargon — what actually has to happen for a molecular diagnostic product to be sold legally and successfully in Brazil.

What is an in vitro diagnostic (IVD) product?

Before talking about the market, it is worth aligning on the concept. An in vitro diagnostic product — IVD — is any product used to run tests on samples taken from the human body, such as blood, urine, swabs or tissue, without those samples being put back into the body.

Everyday examples include:

• A qPCR kit that detects a virus in a nasal swab sample
• A lateral-flow rapid test for dengue or HIV
• A genetic sequencing panel that identifies mutations in tumour cells
• A DNA extraction reagent used as part of a diagnostic workflow

To be sold legally in Brazil, all of these products must be regularised with ANVISA — the Brazilian Health Regulatory Agency — either by notification or by registration, depending on their risk class. That process has its own rules, timelines and requirements, which differ from what the manufacturer may already have done to place the product in Europe (CE Mark) or the United States (FDA).

Why does Brazil not simply accept the CE Mark?

It is one of the most frequent questions from international manufacturers. The short answer: ANVISA carries out its own assessment of the dossier, and Brazil has a population with its own epidemiological profile — prevalences, genotypes and circulating variants that can change a test’s performance compared with what was measured in Europe or the United States.

That does not mean the CE Mark has no value in Brazil — much of the technical documentation can be reused. But it does not give access to the reliance pathway under IN 290/2024, which accepts decisions from the FDA, Health Canada, the TGA (Australia) and the MHLW (Japan), not from the European Union. Nor does it replace:

• Performance data that represents the Brazilian population, where performance may vary locally
• Documentation translated into Portuguese and adapted to Brazilian requirements
• The specific requirements of RDC 830/2023 — the resolution that has governed IVD notification and registration in Brazil since June 2024

What is RDC 830/2023?
Collegiate Board Resolution No. 830 of 2023, in force since 1 June 2024, is ANVISA’s regulation for in vitro diagnostic products — it replaced the former RDC 36/2015. It sorts products into four risk classes (I to IV): classes I and II go through notification; classes III and IV through registration, with heavier requirements.
A qPCR kit for infectious diseases, for example, usually falls into Class III — which means the manufacturer must submit analytical and clinical performance data, the Good Manufacturing Practice Certificate (CBPF) and complete manufacturing documentation and labelling in Portuguese.

What has to happen before you can sell in Brazil?

Put simply, bringing an IVD product into Brazil runs through three major stages:

1. Strategic assessment

Before any document is submitted, you need to understand: which market segment suits the product best? Which competitors are already registered? What is the product’s correct risk class under ANVISA’s rules? Are there gaps in the performance data that must be closed before moving forward?

This stage prevents the most expensive mistake in the sector: building the dossier in the wrong direction and only finding out after months of work.

2. Scientific validation

For Class III and IV products, RDC 830/2023 requires analytical and clinical performance data — including clinical sensitivity and specificity. Data generated with Brazilian samples strengthens the dossier, especially where performance may vary with local genotypes or prevalences. These studies usually follow internationally recognised methods, such as the CLSI guidelines, with 95% confidence intervals.

This is the stage that most surprises international manufacturers — and the one that causes the most delay when it is not planned ahead.

3. Dossier submission and ANVISA registration

With the data in hand, the dossier is built to the requirements of RDC 830/2023, filed through ANVISA’s Solicita system and followed throughout the review. ANVISA’s review alone took about 200 days on average for IVD products between July 2024 and June 2025, according to a study by ABIIS — not counting the time to generate the data, obtain the CBPF and answer any deficiency letters.

How long does it take in practice?

ANVISA’s review is only part of the road. For a Class III product, once you add data generation, the CBPF and dossier preparation, the full journey is measured in years, not months — and what weighs most on the timeline is reaching submission with the right data.
Class I and II products go through notification and do not require a CBPF: the road is much shorter.
A technical deficiency letter pauses the review until the manufacturer responds — and responding well depends on having the right data from the start.

And after registration?

ANVISA registration is an important milestone — but it is the start of the commercial phase, not the end of the process. After registration, the manufacturer needs a technically qualified distributor, technical material adapted to the Brazilian buyer, reference healthcare professionals (KOLs) who know and recommend the product, and a clear segment strategy.

Many companies reach registration after years of work only to find that none of this is ready — and many more months go by before the first meaningful sales.

Conclusion: what should you do first?

Before investing in validation, a dossier or a distributor, the smart first step is a complete strategic assessment that maps your product’s regulatory, technical and commercial gaps specifically for the Brazilian market. That assessment defines the most efficient path, avoids rework and grounds the decision on how much to invest and where.

Want to know exactly what your product is missing to enter Brazil? Start with the Go-to-Brazil Program, or run the free ANVISA Readiness assessment (in Portuguese).

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Sources

• RDC 830/2023 — full text (LegisWeb, Portuguese)
• ANVISA — Q&A on RDC 830/2023 (Portuguese)
• IN 290/2024 — regulatory reliance (AnvisaLegis, Portuguese)
• ABIIS study on ANVISA review times for medical devices (CBDL, Feb 2026, Portuguese)