Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of a class III or IV in vitro diagnostic device

Brazil · Brazilian Health Regulatory Agency · Diagnostics (IVD)

Device: registration or licence with the regulatorHigh confidenceLast verified October 3, 2026

Review target

365 days

regulation

Legal time limit

Not published

Steps

9 requirements

What is the Registration of a class III or IV in vitro diagnostic device in Brazil?

IVDs in classes III and IV need registration after a technical review, with a response target of 365 days. The dossier covers performance studies, stability on at least three lots and clinical performance where relevant. Registration waits for an Anvisa GMP certificate and lasts 10 years. IVDs, including instruments, that fall in class III or IV under the IVD classification rules.

How long does the Registration of a class III or IV in vitro diagnostic device take?

The official review target is 365 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the Registration of a class III or IV in vitro diagnostic device cost?

The registration fee, ivds and other health products (not large equipment) is R$15,619 for Fee table in force when checked (2026-10-03). A reduced fee of R$1,562 applies in some cases (Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 780.96).

What are the steps of the Registration of a class III or IV in vitro diagnostic device?

1. File registration and pay fee; 2. Technical review (365 days); 3. Additional information (clock stopped); 4. Registration published.

Outcome: Registration published in the Official Gazette, valid for 10 years. Valid for 10 years.

Legal basis: Lei 6.360/1976; Anvisa RDC 830/2023

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 365 days end to end with the official step targets. Targets, not actual times.

Approvals per year, device: registration or licence with the regulator in Brazil

From the official approvals data of this market, all products of this pathway type and segment

Steps

In order, with the official target for each step

1. File registration and pay feeForm, labels, instructions, technical dossier, manufacturer declaration for imports and GMP certificate or request.
2. Technical review365 daysResponse target of 365 days.
3. Additional information (clock stopped)clock stopped, only in some casesThe company answers technical requirements.
4. Registration publishedGranted only after a valid GMP certificate is published.

Requirements

What the applicant must provide or meet

Performance evaluation

Analytical performance studiesAccuracy, precision, analytical sensitivity and specificity, measuring range, cut-off and assay validation, as applicable.

Clinical evaluation

Clinical performance(in some cases)Where applicable, a summary of clinical evidence with clinical sensitivity and specificity, and expected values.

Quality and manufacturing

Stability on at least three lotsShelf life from real time studies, or accelerated with real time ongoing, on at least 3 lots.

Other

Prior laboratory analysis when required(in some cases)When required, a satisfactory prior analysis report from a national public health laboratory.

Inspection

Anvisa GMP certificateApproval depends on publication of a valid Anvisa GMP certificate.

Local presence

Brazilian holder (maker or importer)The notification or registration holder is a company in Brazil, the manufacturer or importer, responsible for the device in the country. For imported devices, the foreign legal manufacturer gives a legalized declaration, no older than two years, authorizing the company to represent and sell its products in Brazil.

Language

Portuguese labeling and instructionsPetition forms, instructions for use and labels must be in Portuguese. Other documents may be in Portuguese, Spanish or English.

Labeling

Instructions for use uploaded to the agency repositoryThe holder uploads the instructions for use within 30 days after publication.

After approval

Technovigilance reportingDeaths, serious threats to public health and counterfeits in Brazil are reported within 72 hours; serious adverse events without death within 10 calendar days.

Official time targets

Targets, not actual review times

Review targetregulation. Official response target, not an observed time.

365 days

Fees

Official amounts in the local currency

Fee	Amount
Registration fee, IVDs and other health products (not large equipment)Application · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 780.96.	R$15,619reduced R$1,562

Fee

Amount

Registration fee, IVDs and other health products (not large equipment)Application · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 780.96.

R$15,619reduced R$1,562