IVD registration in Brazil depends first on the risk class. ANVISA, the Brazilian Health Regulatory Agency, sorts every in vitro diagnostic (IVD) device into Class I, II, III or IV. Classes I and II are notified. Classes III and IV are registered. RDC No. 830/2023, in force since 1 June 2024, sets these rules.
The class also decides the documents ANVISA reviews, the Good Manufacturing Practices (GMP) evidence needed and how long the authorization lasts. So manufacturers must confirm the class before preparing the dossier, label or filing, because a wrong class can lead to cancellation.
This article covers ANVISA IVD classification, IVD technical dossier requirements, labeling and post-market duties.
Brazil’s IVD Regulatory Framework
ANVISA decides whether an IVD can be sold in Brazil. It regulates and inspects health products and grants their registration or notification. Under Law 6.360/1976, Art. 12 no health product may be made or sold in Brazil before it is registered, unless it is exempt.
Key regulations governing IVDs in Brazil
RDC 830/2023 is the main rule, but it does not work alone. Manufacturers also meet these:
- RDC 830/2023: classification, notification, registration, labeling, dossier, changes, validity and cancellation
- IN 320/2024: grouping IVDs into families
- RDC 665/2022 and RDC 687/2022: GMP and GMP certification
- RDC 67/2009 and RDC 551/2021: adverse events and field actions
- RDC 591/2021: Unique Device Identification, or UDI
RDC 830/2023 is in force and covers IVDs used on human samples. It was published on 11 December 2023, took effect on 1 June 2024 (Art. 71) and replaced RDC 36/2015. The rule covers reagents, calibrators, controls, sample collectors, software and instruments used to analyze human samples in vitro.
Some laboratory products sit outside it:
- research-use-only (RUO) products
- in-house reagents used in the same laboratory
- proficiency-testing and general laboratory materials
- products for non-human samples
Products made in Brazil only for export need no notification or registration.
IVD Risk Classification Under ANVISA
ANVISA divide IVDs into four classes, I to IV, based on the risk to the patient and to public health. The class decides the pathway.
| Class | Risk | Pathway |
| I | Low individual risk, low public health risk | Notification |
| II | Medium individual risk and/or low public health risk | Notification |
| III | High individual risk and/or medium public health risk | Registration |
| IV | High individual risk, high public health risk | Registration |
Class I is for laboratory support products: buffers, diluents, stains, culture media, sample collection materials and DNA/RNA extraction products. Class II is the default class. It holds devices no other rule covers, instruments that produce results and controls without assigned values.
Class IV covers tests that screen blood, cells, tissues or organs for transmissible agents, and tests for agents that cause potentially lethal, fast-spreading disease . ABO, Rhesus, Kell, Kidd and Duffy typing is also Class IV. Class III includes tests for sexually transmitted agents, cancer, genetic conditions, companion diagnostics and congenital disease screening. Compulsory-notification diseases fall in Class III unless an earlier rule gives Class IV.
Classification rules based on intended purpose and public health risk
The intended purpose sets the class. If a device has several purposes or fits several rules, the higher class applies, and ANVISA decides doubtful cases . For example, the same hCG test is Class II for pregnancy detection and Class III for assessing congenital disorder risk (ANVISA’s manual). Classes can change when notifiable-disease or WHO priority lists change.
Self-tests are the exception to watch. They are Class III, or Class II when the result does not point to a critical clinical state. ANVISA does not allow self-test status for many purposes, including infections, blood typing and genetic testing.
ANVISA Notification vs. Registration Requirements
Notification requirements for Class I and Class II IVDs
Notification is the lighter procedure, and it applies to Class I and II devices. IVD notification in Brazil means filing the form, product and label images, instructions for use, the legal manufacturer’s authorization for imports, any family indication and the fee. Class II also files the technical dossier. ANVISA does not run a technical review before the product counts as regularized. It processes the filing within 30 days, but it can audit a notification at any time.
Registration requirements for Class III and Class IV IVDs
Registration is the full review, and it applies to Class III and IV devices. It adds the complete dossier and either a GMP certificate (CBPF) or proof that the CBPF was requested. ANVISA reviews the file and may issue technical requirements. The grant depends on a valid CBPF.
| Notification (Classes I, II) |
Registration (Classes III, IV)
|
|
| ANVISA review | None before regularization; later audits | Document review |
| Technical dossier | Class I: kept, not filed. Class II: filed | Filed |
| Clinical performance data | Not required in Annex II |
Required when applicable
|
| GMP evidence | No CBPF filing; GMP duty still applies | CBPF or CBPF request |
| Validity | No expiry |
10 years, then revalidation
|
| Changes | Applied on filing, unless non-reportable |
Approval, immediate or non-reportable
|
| Review time | Processed within 30 days | No fixed time |
Product grouping and family applications, where applicable
Several IVDs can share one application, but only within limits. Under IN 320/2024, the products must come from the same legal manufacturer, use similar technology and share an indication, and the group must match one of the listed grouping options. Instruments and reagents cannot sit in the same family. A single-product application cannot be turned into a family later. If ANVISA cancels one product for irregularity, the others in the family are cancelled too. Similar names or intended uses do not qualify products on their own.
Requirements for IVD Market Entry in Brazil
Market entry in Brazil depends on four things: a Brazilian holder, local licenses, the manufacturer’s authorization and GMP compliance.
Brazilian applicant and local regulatory responsibilities: Every IVD sold in Brazil needs a Brazilian company responsible for it. ANVISA calls this company the holder. The holder can be the manufacturer or an importer. It appoints a legal representative and a technical manager, and it answers to ANVISA for the product.
A foreign manufacturer without a Brazilian entity must sign an agreement with a Brazilian company that accepts this role. That company does not have to be a subsidiary.
Company licensing and applicable operating authorization: The Brazilian company needs two licenses before it can file. The first is the Company Operating Authorization (AFE) from ANVISA, which only companies established in Brazil can request. The second is the sanitary license from the local state or municipal health authority.
Foreign manufacturer documentation and authorization: For imported IVDs, the legal manufacturer must issue a declaration authorizing the Brazilian company to represent and sell the product. The declaration is apostilled or consularized and written in Portuguese, English or Spanish, or sent with a sworn translation. If it shows no validity date, it must be no more than two years old. The foreign manufacturer also needs a record with ANVISA. For Class I and II devices, including IVDs, this request goes through Solicita.
Applicable Good Manufacturing Practices (GMP) requirements: GMP applies to every company that makes, imports or sells IVDs. Class III and IV products also need a GMP certificate (CBPF) for the plant, in Brazil or abroad, and the certificate class must match the product class. Notified products need no CBPF filing, but the GMP duty still applies. A product may be made or imported for sale only after its number is published.
Step-by-Step ANVISA IVD Submission Process
The ANVISA submission process has six steps. Each step must be complete before you submit, because a petition missing a required document is rejected.
Step 1: Determine product classification and intended use.
Write the intended-use statement, apply Annex I, and record the class and rule number.
Step 2: Identify the appropriate regulatory pathway.
Class I and II means notification. Class III and IV means registration. Decide between a single product and a family.
Step 3: Prepare the technical and administrative documentation.
Use the document list for your petition subject in the ANVISA subject query. The legal and technical managers sign digitally.
Step 4: Submit the notification or registration application.
File through Solicita. Filing is electronic only.
Step 5: Pay applicable fees and address regulatory queries.
The fee depends on the petition subject and company size. The largest company tier pays R$ 15,619.20 for registration, R$ 21,274.80 for a family registration and, apparently, R$ 3,514.32 for notification. Smaller companies get discounts of 15% to 95%.
Pay within 30 days, and confirm the amount in Solicita because fees can be updated. Answer technical requirements within 120 days. Payment does not guarantee approval.
Step 6: Verify the published regulatory status before commercialization.
Authorization is published in the Diário Oficial da União (DOU). Confirm it on the ANVISA product consultation page before shipping.
Technical Documentation and Performance Evidence
The technical dossier proves that the IVD is safe and performs as claimed. ANVISA’s rules (RDC 830/2023) set what it must contain, and the requirements change with the product’s risk class. A complete dossier covers the following areas:
- Product description, components, and specifications: The dossier describes the analyte, function, intended user, sample types, composition, packaging, accessories, and software. If the product is already authorized in other countries, those are listed too.
- Analytical and clinical performance evidence: Analytical studies must cover accuracy, precision, sensitivity, specificity, measuring range, and cut-off. Clinical performance data is required only for Class III and IV products.
- Risk management, verification, and validation: The manufacturer must document hazard identification, mitigation measures, and acceptance criteria. ANVISA recommends ISO 14971:2020. That is guidance, though, not a legal rule.
- Stability and shelf-life data: Data from at least three lots is expected. Real-time data is accepted, as is accelerated data backed by ongoing real-time studies. In-use and transport stability must be included, while instruments are excluded.
- Manufacturing and quality-system documentation: The manufacturer must lists every manufacturing site and subcontractor, then describes the process and its controls and includes a flowchart.
IVD Labeling Requirements in Brazil
Every IVD sold in Brazil must carry its labels and instructions for use in Portuguese. Forms, instructions, manuals, and label mock-ups must all be in Portuguese. Other dossier documents may be in Portuguese, Spanish, or English. Standard ISO 15223 symbols may be used on labels, but products meant for lay users must include an explanation of each symbol.
Outer label must show:
- Trade name
- Legal manufacturer’s name and address
- Holder’s name, address, and CNPJ (the Brazilian company tax number)
- Technical manager and council number
- ANVISA number
- IVD statement
- Lot number
- Expiry date
- Storage conditions
- Warnings
- Components
Primary labels carry a shorter set of details, while instrument labels must be indelible.
The instructions for use must be thorough. They must explain the intended purpose, who the user is, how the test works, which substances can interfere, how the product performs, what risks remain and how to dispose of it. For lay-user products, there is one extra requirement. The instructions must also tell people when to see a health professional.
Among Brazilian companies, only the legal manufacturer and the holder may appear on the label, and a customer service contact should be added.
Storage and expiry information goes on both outer and primary labels, while in-use stability belongs in the instructions. The UDI is added alongside these fields.
Post-Market Obligations for IVDs in Brazil
Getting an IVD approved in Brazil is only the start. Holders must manage changes, renew registrations, report adverse events, carry out field actions, and keep their status active.
Changes to registered or notified products
Not every change is handled the same way. RDC 830 sorts changes into three types:
- Approval-required changes: apply only after ANVISA publishes the decision in the DOU.
- Immediate-implementation changes: apply as soon as they are filed. Class I and II changes follow this route unless they are non-reportable.
- Non-reportable changes: stay in the manufacturer’s quality system.
Old labels may be used up within 120 days, but not when the change is a safety fix. Updated instructions for use must be uploaded within 30 days of publication.
Registration validity and revalidation
A registration lasts 10 years. Revalidation must be filed 12 to 6 months before expiry, together with the manufacturer’s declaration and a valid CBPF (Brazil’s GMP certificate. Notifications do not expire.
Adverse-Event Reporting and Post-Market Surveillance
Holders must appoint a technovigilance manager. The reporting deadline starts when the holder learns of an event in Brazil:
- 72 hours: death, serious public health threat, or counterfeiting
- 10 days: serious adverse event without death, or a non-serious event that could recur seriously
- 30 days: certain technical complaints
ANVISA treats notification holders like registration holders, so these duties also cover Class I and II products. Reports go through Notivisa.
Field actions follow RDC 551/2021, and the holder must notify ANVISA within 3 days when the action involves media use or a serious threat. The deadline is 10 days when a serious event is a risk, and 30 days in all other cases. IVD notices are filed in Solicita.
A product keeps its status only while it meets GMP, safety, and performance requirements. Ignoring an ANVISA request for adjustments for 30 days risks cancellation. A holder that stops selling the product must request cancellation. ANVISA can also cancel for false information, health risk, missing documents or misclassification.
Conclusion
Entering Brazil is a step-by-step process. It starts with classification, because everything else depends on it. After that come the route, the holder, the GMP evidence, the dossier, and the label. Get it wrong, and it can cost you the registration. Even after approval, post-approval duties must be met to keep it valid.
If you need support with ANVISA IVD classification, regulatory submissions, technical documentation or Brazilian market-entry planning, explore Artixio’s regulatory services in Brazil or contact our experts at info@artixio.com for guidance tailored to your product and market-entry timeline.
FAQs
Q1. How are IVDs classified in Brazil?
By intended purpose and risk, into Classes I to IV, using eight rules in Annex I of RDC 830/2023. Several purposes or rules give the higher class.
Q2. Which IVD classes require notification or registration?
Classes I and II require notification. Classes III and IV require registration.
Q3. Can a foreign manufacturer apply directly to ANVISA?
No, not without a Brazilian company. ANVISA’s manual says only companies established in Brazil can obtain the AFE, and a foreign company needs an agreement with a Brazilian company that takes responsibility.
Q4. What documents are required for IVD registration?
The form, label images, instructions for use, the technical dossier, any family indication, the manufacturer’s authorization declaration for imports, a CBPF or CBPF request, and the fee. Class II notification needs a similar set without the CBPF.
Q5. Are Portuguese labels required for IVDs?
Yes. Label and instruction information must be in Portuguese.
Q6. How long is ANVISA IVD registration valid?
Ten years from DOU publication, renewable by revalidation filed 12 to 6 months before expiry. Notifications do not expire.
Q7. How can manufacturers verify an IVD’s regulatory status?
Check the DOU publication or search the ANVISA product consultation.
