Classification, the notification and registration routes, the Brazilian holder requirement, BGMP certification, INMETRO, timelines, fees, reliance, and UDI/SIUD — one complete map of Brazil's device pathway.
October 1, 2026
14
min read
By
BioAccess Editorial Team
Brazil
ANVISA
medical device registration
market access
Latin America
registro ANVISA
RDC 751/2022
**Key takeaways**
- • Two routes by risk class. Class I/II devices use notificação — a simplified petition ANVISA does not technically review, with indeterminate validity. Class III/IV use registro — a full dossier review, with 10-year validity.
- • No direct foreign registration. The filing must be held by a Brazilian-domiciled detentor (Brazilian Registration Holder, BRH) with an ANVISA operating authorization.
- • BGMP certification (CBPF) is required for Class III/IV — the manufacturer's facilities must hold ANVISA's good manufacturing practices certificate (MDSAP audit reports are accepted).
- • Plan for 6–18 months in practice for a Class III/IV registration; notifications publish within weeks. Confirm the timeline at the proposal stage.
- • Reliance is real but narrow. IN 290/2024 gives Class III/IV devices approved by TGA, Health Canada, FDA, or Japan's MHLW an optimized review — CE mark alone does not qualify.
**Who is this for?**
This guide is for regulatory affairs directors, market access managers, and MedTech executives planning to commercialize medical devices in Brazil — from Class I accessories to Class IV implants — who need the full ANVISA pathway mapped before they commit budget and timelines.
The short answer
Every medical device marketed in Brazil must be regularized with ANVISA before import and sale. The route depends on risk class: Class I and II devices follow notificação (notification) — a simplified petition that ANVISA does not technically review, published in the Diário Oficial da União (DOU), with indeterminate validity (no revalidation). Class III and IV devices follow registro (registration) — a full technical-dossier review with rounds of technical questions, valid for 10 years and revalidatable for equal periods. In both cases the filing is made in the name of a Brazilian-domiciled holder (detentor / BRH), never directly by the foreign manufacturer. For the commercial model that works best in Brazil — your distributor as holder and importer, bioaccess® as your registration processor — see the bioaccess® market access services.
What is ANVISA and which law requires registration?
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's federal health surveillance agency, created by Law 9.782/1999 and linked to the Ministry of Health. It regulates medical devices, drugs, foods, cosmetics, and sanitizing products. The legal framework for devices rests on:
- Law 6.360/1976 — the sanitary-surveillance framework law: commercialization of products under health surveillance requires registration or notification with ANVISA; Law 13.097/2015 amended it to set registration validity at up to 10 years
- Law 9.782/1999 — creates ANVISA and institutes the TFVS (taxa de fiscalização de vigilância sanitária), the government fee levied on regulated activities
- RDC 751/2022 — the consolidated device regulation: risk classification rules (aligned with EU MDR), the notificação and registro regimes, post-registration changes, technical dossier structure, labeling and IFU requirements; published September 21, 2022, in force since March 1, 2023; revoked RDC 185/2001, RDC 40/2015, and RDC 15/2014
- RDC 665/2022 — Brazilian Good Manufacturing Practices (BGMP) standards for medical devices (harmonized update of RDC 16/2013); RDC 687/2022 governs the CBPF certification process
- Law 6.437/1977 — the sanitary-infractions law: the penalties for non-compliance
- IN 290/2024 — the optimized (reliance) analysis procedure for Class III/IV devices approved by equivalent foreign regulators
Under this framework, no medical device may be imported or commercialized in Brazil without a valid notificação or registro — the obligation attaches to the product, not to how or where it was first cleared.
How are devices classified, and which route applies?
RDC 751/2022 classifies devices into four risk classes — I (low), II (medium), III (high), IV (maximum) — using 22 classification rules harmonized with the EU MDR model. The rules account for intended use, invasiveness, duration of body contact, and contact with the central circulatory or nervous systems — not simply on implantability. The resolution also added specific rules for software as a medical device (SaMD) and nanomaterials. Because the rules changed from RDC 185/2001, devices classified under the old regime can sit in a different class today — ANVISA required companies to re-enframe products whose regime changed at their first secondary petition after RDC 751/2022 took effect.
| Route | Risk classes | What ANVISA does | Validity |
|---|---|---|---|
| Notificação | Class I and II | Simplified petition; no technical review by ANVISA; publication in the DOU | Indeterminate — never revalidated; can be cancelled on audit |
| Registro | Class III and IV | Full technical-dossier review with rounds of technical questions (exigências) | 10 years from DOU publication; revalidatable for equal periods |
Illustrative examples (confirm the classification of your device by applying RDC 751/2022's rules): Class I — non-invasive accessories, simple manual instruments. Class II — peripheral diagnostic catheters, guidewires, introducer sheaths. Class III — coronary catheters, neurovascular devices, short-term implants. Class IV — pacemakers, drug-eluting implants, devices incorporating medicinal substances. Getting the class right at the start determines the route, the dossier depth, and whether BGMP certification is required.
Important: notification is not a waiver of technical substance. RDC 751/2022 requires the holder to maintain the complete technical dossier (per the resolution's Chapter VII structure, aligned with the IMDRF table of contents) on file for Class I/II products — ANVISA does not review it upfront, but it is subject to review on audit, and non-compliance can lead to cancellation.
Can a foreign manufacturer register directly with ANVISA?
No. The notificação or registro is granted in the name of the detentor — a Brazilian-domiciled company, known internationally as the Brazilian Registration Holder (BRH). The BRH:
- Holds the ANVISA notification or registration in its name
- Acts as the regulatory liaison with ANVISA (petitions, exigência responses, secondary petitions such as changes, revalidation, and transfer of ownership)
- Manages post-market duties — tecnovigilância: field safety notices, corrective actions, and UDI/SIUD transmission obligations
- Must hold an Autorização de Funcionamento de Empresa (AFE) — ANVISA's company operating authorization for health-product activities
The foreign manufacturer authorizes the BRH in writing to petition in its name. Separately, the company that physically imports the goods — the importer of record — also needs an AFE and must operate through Brazil's single-window trade systems (see the import section). INMETRO certification, where required, is likewise held in the name of the Brazilian entity.
**Holder choice is a commercial decision, not just a regulatory one**
Changing the detentor later is a formal secondary petition (transfer of ownership) requiring manufacturer consent — a frequent commercial friction point when a third party holds the registration. Our recommended model for Brazil: your Brazilian distributor serves as the detentor/BRH and importer of record, while bioaccess® acts as the third-party registration processor — preparing the dossier, managing translations, liaising with ANVISA, and supporting tecnovigilância. Build registration-transfer clauses into your distribution agreement — reviewed by Brazilian counsel to ensure they are locally enforceable — so the regularização can move to a replacement distributor if the first one fails to meet expectations. (Argentina is the exception: it is a large enough market that bioaccess® provides full titleholder and importation services there directly.)
What is BGMP (CBPF) certification and when is it required?
For Class III and IV devices, ANVISA requires proof of compliance with Brazilian Good Manufacturing Practices — the CBPF (Certificado de Boas Práticas de Fabricação). Per RDC 687/2022, the manufacturing units subject to certification are those of risk classes III and IV that produce the final product (on their own behalf or for another company), perform the final release of the final product combined with at least one production stage, or manufacture medical software (SaMD). The BGMP standards themselves are set by RDC 665/2022.
Practical points that commonly surprise first-time filers:
- ISO 13485 alone does not replace the CBPF — but ANVISA is a member of the Medical Device Single Audit Program (MDSAP), and MDSAP audit reports can be used to issue the CBPF without a full ANVISA inspection
- The registro petition can move while the BGMP certification is in process, but the certification must be in place — sequence it early, since it is frequently the long pole
- Sterilization contractors whose packaging is a sterile barrier system count as a production stage and can fall within the certification scope
What does the ANVISA dossier require?
All petitions are filed in Brazilian Portuguese through ANVISA's petitioning system, and the technical dossier follows the structure in RDC 751/2022's Chapter VII — modeled on the IMDRF table of contents so dossiers built for multiple jurisdictions can be reused. The depth differs by route, but the structure is the same.
Administrative documents
- BRH's AFE (company operating authorization) and CNPJ registration
- Written authorization from the legal manufacturer appointing the BRH
- List of devices, models, components, and variants — devices must be correctly grouped into families per ANVISA's family rules
- Proof of payment of the TFVS government fee (GRU)
- CBPF (or equivalent BGMP proof) for Class III/IV manufacturers — RDC 687/2022
- INMETRO certificate where the device is subject to compulsory certification
Technical dossier
- Detailed device description, fundamentals of operation, packaging and presentation forms
- Intended purpose, indications, contraindications, intended user and use environment
- Global market history of the device
- Risk management per ISO 14971; list of essential safety and performance requirements and applicable technical standards
- Physical, mechanical, and material characterization; biocompatibility assessment per ISO 10993; pyrogenicity assessment
- Electrical safety, mechanical protection, and electromagnetic compatibility (for active/electrical devices)
- Software/firmware description and validation (for devices with software, including SaMD)
- Sterilization validation and residual toxicity; packaging and shelf-life validation
- Usability / human factors evidence
- Clinical evidence: general summary of clinical data plus relevant clinical literature — expected in full for Class III/IV
- Manufacturing information: manufacturing unit addresses and process flowcharts
- Labeling and Instructions for Use in Portuguese (non-printed IFU formats are permitted under RDC 751/2022)
**Portuguese and family-grouping rule of thumb**
Every document in the filing must be in Brazilian Portuguese — sworn or certified translations where the original is foreign. And family grouping is where many filings go wrong: ANVISA's family rules are strict about which models share one petition, and mis-grouping is one of the most common causes of exigências. Confirm the grouping strategy before the filing is protocolled.
Do electromedical devices need INMETRO certification?
Yes, if the device is subject to compulsory conformity assessment. Medical electrical equipment covered by the IEC 60601 family of standards (ABNT NBR IEC 60601 series) must obtain INMETRO certification through an accredited certification body before ANVISA registration — some non-electrical devices (e.g., sterile syringes, surgical gloves, certain implants) are also on the compulsory list. INMETRO assesses technical safety and construction against the applicable standards — product testing plus factory quality-system audit — while ANVISA separately evaluates safety, efficacy, and quality for market authorization. INMETRO certification is held in the name of the Brazilian entity (your BRH), typically carries a five-year validity with annual factory audits, and must be in place before the ANVISA filing for devices on the list — so confirm compulsory-list status and sequence certification early. bioaccess® confirms the INMETRO applicability and the sequencing at the proposal stage.
How long does ANVISA registration take?
Notificação (Class I/II): there is no ANVISA technical review — once the petition is protocolled and the fee is paid, ANVISA publishes the notification. In practice this is commonly a matter of weeks. Note that RDC 751/2022 gives ANVISA up to 30 days from protocol to publish immediate-implementation changes — an indication of the cadence for non-reviewed petitions, not a guarantee for initial filings.
Registro (Class III/IV): a substantive technical review with rounds of exigências (technical questions), each round with a fixed response period — a petition that accumulates exigências stops the clock and must be answered within the deadline or risk refusal. In practice, first registrations commonly take 6–18 months, and industry sources report some Class III/IV filings running 9–20 months, depending on the device class, dossier quality, BGMP certification status, and the number of exigência rounds. Revalidations and changes are usually faster when the file is clean.
| Phase | Typical duration | Key activities |
|---|---|---|
| Classification and dossier build | 2–4 months | RDC 751/2022 classification, family grouping, translations, gap analysis |
| BGMP/CBPF certification (Class III/IV) | 4–12 months | ANVISA inspection or MDSAP-report route; run in parallel with the dossier |
| INMETRO certification (if applicable) | 3–12 months | Product testing + factory audit through an accredited body |
| Filing and technical review | 6–18 months | Protocol, exigência rounds, resolution and DOU publication |
| UDI/SIUD readiness (before market placement) | Parallel | UDI assignment, SIUD transmission before commercialization |
Sequence the long poles — BGMP and INMETRO — in parallel with the dossier build rather than after it; waiting for the ANVISA filing to start them is the most common timeline error. bioaccess® confirms the expected timeline at the proposal stage based on the device's class and dossier readiness.
What does ANVISA registration cost?
ANVISA government fees are the TFVS (taxa de fiscalização de vigilância sanitária), instituted by Law 9.782/1999. The fee values are set in the law's Annex II, updated by Portaria Interministerial MF-MS 45/2017 and regulated by RDC 198/2017, and are collected via GRU (Guia de Recolhimento da União) through ANVISA's petitioning system. Fees scale with the company's size tier, and separate fees apply to each petition type (notification, registration, revalidation, changes, CBPF certification, import licenses). Because the table is updated by interministerial ordinance, confirm the current TFVS values at the proposal stage — never budget from a published table without checking its date.
The real budget drivers, as with every LATAM market, are the dossier build, certified Portuguese translations, BGMP/INMETRO certification, and the regulatory filing work itself — government fees are the smaller line item. bioaccess® quotes the full registration-processing scope (dossier preparation, translations, agency liaison, tecnovigilância support) while your distributor holds the regularização as detentor and importer of record. See the bioaccess® market access hub for current commercial terms.
Is there a fast track for FDA-cleared or CE-marked devices?
Yes — narrow, and FDA-cleared qualifies while CE-marked alone does not. Under IN 290/2024 (published April 8, 2024, applicable from June 3, 2024), ANVISA runs an optimized analysis procedure for Class III and IV devices already approved by an Equivalent Foreign Regulatory Authority (EFRA):
| EFRA | Accepted evidence of approval |
|---|---|
| Australia — TGA | Australian Register of Therapeutic Goods (ARTG) |
| Canada — Health Canada | Medical Device Licence |
| United States — FDA | 510(k) clearance, PMA, or De Novo |
| Japan — MHLW | Premarket approval (Shonin) |
Conditions: the device must be essentially identical to the foreign-approved version — same indications and intended use, same manufacturers — and the company must submit the foreign documentation demonstrating it. The procedure is an abbreviated review, not an automatic approval: ANVISA keeps the final decision and can still require Brazil-specific data. The European Union is not on the EFRA list, so a CE mark alone does not qualify a device for this pathway.
Strategy note: a Brazil registration earned through reliance also unlocks regional leverage — Mexico's abbreviated route (operational since June 2026) lets COFEPRIS build on ANVISA's prior assessment with a maximum decision timeframe of 45 business days. See Brazil's 2026 regulatory reset for the full reliance-plus-UDI playbook.
What are the UDI and SIUD obligations?
Brazil's unique device identification system is live. RDC 591/2021 established UDI, and IN 426/2026 (published February 13, 2026) is the operating rulebook for SIUD — Brazil's UDI database. The obligations sit squarely on the registration holder:
- UDI data (the UDI-DI component) must be transmitted to SIUD before the device is placed on the Brazilian market, and must match ANVISA-approved product information — equivalence is the holder's responsibility
- The holder may authorize a third party to transmit, but remains responsible for the data
- Corrections are permitted within 60 calendar days after publication; changes requiring a new UDI-DI must be processed within 30 days; discontinued or cancelled devices must be inactivated within 30 days
This makes holder selection more consequential: your BRH now needs SIUD transmission capability, not just filing capacity. Assign the UDI workstream an owner before launch, device model by device model, and keep ANVISA-approved data and SIUD data synchronized. Full detail — including the grace-period status and the risk-class sequencing — is in Brazil's 2026 regulatory reset.
How does import licensing work?
Registration alone does not clear goods. Brazil's import of health products is governed by RDC 81/2008 (the import technical regulation) through the Portal Único de Comércio Exterior:
- Each shipment needs an import license (LI) registered in Siscomex, plus ANVISA's clearance (anuência) requested as an LPCO in the Portal Único — for medical devices, filed under Chapter XXXIX of RDC 81/2008 (procedures 4 or 5.5)
- The LI/LPCO data — product identification, legal manufacturer, manufacturing unit, sterility, labeling — must match the ANVISA regularização exactly; divergences are grounds for denial
- The importer needs its own ANVISA AFE (company operating authorization) for health-product import, and the bonded terminal/warehouse needs an AFE for storage
- Devices exempt from regularization are also handled in the same LPCO flow — but a commercial device that should be registered cannot clear as exempt
Make your distributor the importer of record: it already holds the AFE, operates in the Portal Único, and — under our recommended model — is the detentor of the regularização, so the product, the filing, and the shipment all line up under one Brazilian entity.
What happens if you import without registration?
The shipment does not clear, and the attempt is a sanitary infraction. ANVISA does not grant anuência for a product without a valid notificação or registro, and without the LPCO the shipment cannot be released. Beyond the hold, Brazil's enforcement is formal:
- Importing products subject to sanitary surveillance without the required non-automatic licensing is a <strong>sanitary infraction under Law 6.437/1977</strong> — penalties include fines, product seizure (apreensão), and interdiction of the establishment
- Commercialization of a health product without the required registration is prohibited under <strong>Law 6.360/1976</strong>
- ANVISA's fiscalização units can audit the BRH's premises, review the held dossier (including for notified Class I/II products), and cancel a notificação found non-compliant
- Public procurement (SUS tenders) and large private hospital networks require a valid regularização in bids — increasingly the strongest commercial driver
**No 'ship first, register later' strategy**
The LPCO will not clear an unregistered device, and there is no compliant workaround — the exemption routes (donations, clinical-investigation imports, single-patient use) are narrow, case-specific, and require their own authorizations. Budget the regularização into your launch timeline from day one.
Frequently Asked Questions
Sources and basis of this article
This article is based on the Brazilian regulatory framework as of October 2026: ANVISA's official Perguntas & Respostas on RDC 751/2022 (gov.br); RDC 687/2022 (CBPF certification, English, gov.br); IN 290/2024 (reliance pathway, English, gov.br); ANVISA's 2024 import workshop presentation on medical-device importation (gov.br); the ANVISA TFVS framework (Law 9.782/1999, Portaria Interministerial MF-MS 45/2017, RDC 198/2017); Law 13.097/2015's 10-year validity framework; and regulatory analysis with Mike Legal AI (decision support, not a licensed attorney). Practice timelines (notification weeks, registration 6–18 months) and INMETRO process details reflect industry sources rather than ANVISA-published service standards — confirm current figures with your holder at the proposal stage. This article is general information, not legal advice.
BA
bioaccess® · An Americas company operating from Canada to Argentina — end-to-end medical device registration and market access services, including ANVISA (Brazil), COFEPRIS (Mexico), DIGEMAPS (Dominican Republic), INVIMA (Colombia), and ANMAT (Argentina).
Market Access Services
Brazil's 2026 Regulatory Reset
Ready to register your device with ANVISA?
Brazil is the largest device market in the Americas south of the Rio Grande — but entry runs through an ANVISA regularização held by a Brazilian detentor, a Portuguese dossier, and for Class III/IV, BGMP certification and a 10-year registration cycle. bioaccess® prepares and prosecutes your ANVISA filing as your third-party registration processor — classification, family grouping, dossier, translations, BGMP and INMETRO sequencing, agency liaison, and tecnovigilância support — while your Brazilian distributor holds the notificação or registro as detentor and importer of record, with transfer clauses in your distribution agreement protecting you if the commercial relationship changes.
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Related resources:
- Brazil's 2026 Regulatory Reset: Reliance, UDI & Clinical Evidence — /blog/brazil-2026-regulatory-reset
- Market Access Services — /market-access
- COFEPRIS medical device registration in Mexico — /blog/cofepris-medical-device-registration-mexico
- U.S. MedTech LATAM market-entry strategy — /blog/us-medical-device-latam-market-entry-strategy-sequence