Brazil Medical Device Registration: 27 FAQs on ANVISA, BRH, BGMP and UDI

Brazil is Latin America’s largest medical device market. Industry estimates place its value above USD 10 billion, with imports supplying roughly 80% of products, and China has been one of the largest sources of new registration applications for several years. The regulatory framework is also undergoing extensive modernisation: RDC 751/2022 fully took effect in March 2023, replacing RDC 185/2001 after 22 years; the IVD-specific RDC 830/2023 and new essential safety and performance requirements under RDC 848/2024 followed in 2024; and UDI requirements are being phased in.

These 27 questions explain the core requirements for medical device registration in Brazil. The key points have been checked against regulations published by ANVISA and in Brazil’s Official Federal Gazette (DOU), current through October 2026. A list of the principal regulations is included at the end for reference and verification.

1. Regulatory authority and legal framework (Q1-Q3)

Q1. Which authority regulates medical devices in Brazil, and what is its legal basis?

Medical devices in Brazil are regulated by ANVISA (Agencia Nacional de Vigilancia Sanitaria), the National Health Surveillance Agency. It was established by Federal Law No. 9,782 of 26 January 1999. Although administratively linked to the Ministry of Health, it is a special autonomous agency with independent technical decision-making authority under law. Its remit covers the full medical device lifecycle: pre-market review, manufacturing and distribution oversight, adverse event monitoring, recalls and enforcement, and international regulatory coordination.

At the statutory level, Law No. 6,360/1976 is Brazil’s principal health surveillance law, Law No. 9,782/1999 defines ANVISA’s powers, and Law No. 6,437/1977 establishes penalties for violations. Within this framework, ANVISA regulates through technical instruments including Collegiate Board Resolutions (RDCs) and Normative Instructions (INs).

Q2. What is the current core regulation, and how does it relate to RDC 185/2001?

The current core regulation is RDC 751/2022, signed on 15 September 2022, published in the DOU on 21 September 2022 and effective from 1 March 2023. Its full title is the Resolution on Risk Classification, Notification and Registration Regimes for Medical Devices, and Labelling and Instructions for Use Requirements. A single instrument covers risk classification, notification (Notificacao), registration (Registro), variations, renewals, cancellations, labelling and instructions for use (IFU).

When it took effect, RDC 751/2022 repealed RDC 185/2001 and other instruments, including RE 1554/2002, RDC 207/2006, certain provisions of IN 4/2012, RDC 15/2014 and RDC 40/2015. Other current regulations directly relevant to medical device oversight in Brazil include:

• RDC 830/2023: the dedicated regulation for in vitro diagnostic devices (IVDs), effective from 1 June 2024;
• RDC 848/2024: essential safety and performance requirements, effective from 4 September 2024, replacing RDC 546/2021 and aligning with IMDRF principles;
• RDC 665/2022: Good Manufacturing Practices for medical devices (BPF);
• RDC 591/2021, as amended by RDC 884/2024: the Unique Device Identification (UDI) system;
• RDC 67/2009 and RDC 551/2021: post-market vigilance and field actions, including recalls.

Q3. How many medical device classes does Brazil have, and what determines classification?

Brazil divides medical devices into four risk classes under Article 5 of RDC 751/2022: Class I for low risk, Class II for medium risk, Class III for high risk and Class IV for the highest risk.

Classification is based on the device’s intended purpose and the 22 classification rules in Annex I of RDC 751/2022, which broadly move towards the EU MDR approach. Key considerations include:

• Invasiveness: whether and to what extent the device enters the body, including through a body orifice or by surgical implantation;
• Duration of use: transient use of less than 60 minutes, short-term use from 60 minutes to 30 days, or long-term use exceeding 30 days;
• Active status: whether the device depends on electrical or another energy source, and whether it delivers energy or medicinal products to the body;
• Special rules: dedicated provisions apply to software as a medical device (SaMD), nanomaterials, substances of biological origin, contraceptive devices and disinfectants for invasive devices, among others.

Three practical rules deserve particular attention. Accessories are classified separately from the parent device. Software controlling hardware follows the hardware’s classification, while standalone software (SaMD) is classified independently. If several rules apply to the same product, the strictest rule prevails under Article 8. ANVISA decides any unresolved classification question.

2. Registration and notification: the two market access pathways (Q4-Q5)

Q4. Which products require registration, and which need only notification?

This is the dividing line between Brazil’s market access pathways under Articles 6 and 7 of RDC 751/2022:

• Class I and Class II (low to medium risk): notification (Notificacao), covering products such as ordinary gauze, examination gloves, basic surgical instruments, and certain infusion and home-use products;
• Class III and Class IV (high to highest risk): registration (Registro), covering products such as intraocular lenses, dialysers, interventional catheters, cardiac stents, pacemakers and high-risk IVD reagents.

Classification directly affects compliance costs and timelines. Class III/IV registration requires the manufacturing site to hold a Brazilian GMP certificate (CBPF), whereas Class I/II notification does not. Classification should therefore be settled before the project starts; an incorrect decision can require the entire application to be reworked.

Q5. What are the main differences between registration and notification, and how long does each remain valid?

The pathways differ in four respects: depth of review, documentation, quality system requirements and validity.

Under either pathway, the approved notification or registration must be published in the DOU and become searchable on ANVISA’s website. Before publication, the product may not be manufactured, imported, displayed for sale or distributed in Brazil under Article 60. No fixed validity for a notification does not mean no continuing obligations: essential safety and performance requirements, retention of the technical dossier and post-market reporting remain in force, and ANVISA may review the documentation at any time.

3. Brazil Registration Holder (BRH) and import clearance (Q6-Q9)

Q6. Can a Chinese manufacturer apply directly to ANVISA for registration?

No. Brazilian law requires a local Brazilian entity to hold the registration or notification. A foreign manufacturer must appoint a qualified Brazilian company as the registration holder (detentor de registro or titular), commonly known in the industry as a Brazil Registration Holder (BRH). The holder submits the application to ANVISA and bears legal responsibility for the product’s compliance in Brazil. The foreign manufacturer authorises it to represent and sell the products through a letter of authorisation (LOA).

Three structures are used in practice: a manufacturer-owned Brazilian subsidiary, an importer or distributor acting as holder, or an independent third-party registration holder. They differ significantly in control, flexibility and exit costs, as discussed in Q8.

Q7. What qualifications must a Brazil Registration Holder have?

A qualified holder is much more than a mailing address. Its legal qualifications include:

1. A legally established Brazilian legal entity with a CNPJ number, the national legal entity registration identifier;

2. An ANVISA Company Operating Authorisation (AFE, Autorizacao de Funcionamento de Empresa), which permits the company to conduct regulated activities in Brazil. If the holder is responsible for imports, the scope of its AFE must include import activities;

3. A state or municipal health licence (Licenca Sanitaria or Alvara), issued for the operating premises by the local health surveillance authority (VISA);

4. A Technical Responsible Person (Responsavel Tecnico) with an appropriate professional qualification, such as pharmacy, engineering or biomedical sciences, registered with the relevant professional council. This person bears individual responsibility for the company’s technical compliance, and their name must appear on the product label under Article 47.

Two common questions arise regarding the AFE. First, it takes effect on DOU publication and has no statutory expiry date; the annual renewal requirement was removed by legislative changes in 2014 and 2015, but the company must maintain compliance and promptly report changes to its information. Second, an AFE is issued for each operating establishment identified by a CNPJ, so medical device businesses generally need one authorisation per site. The statutory response period for an AFE application is 60 days under RDC 416/2020.

Q8. What are the BRH’s specific responsibilities, and why can choosing the wrong holder be so costly?

The holder’s responsibilities span the product lifecycle. It holds the registration or notification and serves as the sole regulatory interface with ANVISA; ensures that labels and IFUs are in Portuguese and that holder and Technical Responsible Person details are accurate; coordinates manufacturing-site GMP certification; reports adverse events and field actions through NOTIVISA; retains the technical dossier for inspection; and issues authorisations to distributors and importers.

The key risk is that the registration certificate belongs to the holder. If the commercial relationship changes, transferring the registration requires the incumbent holder’s cooperation and completion of ANVISA’s transfer procedure. If the relationship breaks down, imports and sales can be frozen for months while costs and timelines are reassessed. If the holder is also the exclusive distributor, a commercial dispute can directly become a regulatory risk.

For manufacturers, an independent third-party holder combined with manufacturer-controlled distribution generally offers greater control and exit flexibility than distributor-held registration. A manufacturer-owned subsidiary provides the strongest control but entails company formation, AFE applications, tax obligations and ongoing maintenance costs. Before selecting a holder, verify its AFE status and authorised scope, medical device registration track record, Technical Responsible Person’s experience and post-market team.

Q9. What additional conditions apply to import clearance after registration?

At product level, registration or notification must be complete and published in the DOU under Article 60. At company level, the following are also required:

1. Importer qualifications: the actual importer must be the registration holder or an entity authorised by it, and its AFE scope must cover imports;

2. Customs qualifications: the importer must be registered for RADAR/Siscomex with the Brazilian Federal Revenue Service (Receita Federal) before it can file import declarations itself;

3. Fully electronic clearance: from 27 April 2026, imports of health-regulated products must use the DUIMP (Declaracao Unica de Importacao), the single import declaration processed through the Single Foreign Trade Portal (Portal Unico de Comercio Exterior), replacing the former LI/DI system. From 25 May 2026, ANVISA also requires a mandatory Import Purpose (Finalidade de Importacao) field. Declaration data must match the registration or notification, or the system will block the entry and route it for inspection.

In practice, customs data including product name, model, registration number and import purpose must align exactly with the registration record. Any inconsistency can cause port delays, storage charges and late-declaration costs.

4. Registration documents: CFS, LOA, GMP and technical dossier (Q10-Q14)

Q10. What core documents are required for a registration (Registro) application?

Article 14 of RDC 751/2022 provides a clear list. An application for an imported product must include:

1. The registration application form, completed electronically using the form on ANVISA’s website under Article 45;

2. The technical dossier (Dossie Tecnico), structured under Chapter VII and Annex II, as discussed in Q14;

3. The manufacturer’s letter of authorisation (LOA), as discussed in Q12;

4. A certificate of free sale (CFS) or equivalent evidence of marketing authorisation, as discussed in Q11;

5. An ANVISA-issued GMP certificate (CBPF) or the receipt for a GMP application. Article 14(2) and (3) allows registration to be submitted and technical analysis to begin on the basis of the GMP application receipt, but approval depends on formal publication of the GMP certificate. GMP certification and registration can therefore proceed in parallel rather than sequentially;

6. An SBAC conformity certificate for products subject to mandatory certification on ANVISA’s list, as discussed in Q21;

7. Evidence of conformity with specific technical regulations, where applicable.

After submission, ANVISA may issue a deficiency request (Exigencia). Applications with incomplete information, expired documents or missing required declarations may be rejected outright under Article 10(4).

Q11. What is a certificate of free sale (CFS), and why is it unavoidable for Class III/IV registration?

A certificate of free sale (Certificado de Livre Comercializacao, CFS) is an official document confirming that a product is legally marketed in its country of manufacture or sale. Article 14(IV) of RDC 751/2022 expressly requires an imported-product registration application to include evidence of marketing authorisation or a CFS issued by the competent authority in the country where the product is manufactured or sold.

Several practical points matter:

• The CFS is mandatory only for Class III/IV registration, not for Class I/II notification;
• If the certificate states no expiry date, it must have been signed within the previous two years;
• Consular legalisation or a Hague apostille is required. Versions not in Portuguese, English or Spanish must be accompanied by a sworn translation;
• The issuing body is normally the competent authority in the exporting country, such as the medical products regulator, or another recognised institution. Chinese companies generally apply to their provincial medical products administration.

Q12. What mandatory requirements apply to the manufacturer’s letter of authorisation (LOA)?

The LOA formally authorises the Brazilian holder to act for the foreign manufacturer. Articles 13 and 14 impose strict requirements on its content and form:

• Language: Portuguese, English or Spanish; any other language requires a sworn translation;
• Signature date: if no validity period is stated, the LOA must have been signed within the previous two years;
• Required content: the names and full addresses of the manufacturer and applicant company; express authorisation for the applicant to represent and sell the manufacturer’s products in Brazil; and a declaration acknowledging and committing to the Good Manufacturing Practice requirements of RDC 665/2022;
• Authentication: consular legalisation or a Hague apostille is required. Brazil and China are parties to the Hague Apostille Convention, which took effect for China on 7 November 2023. Chinese-issued documents can therefore now receive an apostille instead of undergoing traditional consular legalisation.

Q13. What are Brazil’s ISO 13485 and GMP requirements, and can MDSAP replace an on-site inspection?

Brazilian Good Manufacturing Practices for medical devices, known locally as BPF and often abbreviated BGMP in English, are governed by RDC 665/2022. Manufacturers of Class III/IV products, whether domestic or foreign, must obtain an ANVISA-issued GMP certificate (CBPF). This is a prerequisite for registration and renewal under Articles 14(V) and 27(II).

There are two routes to a CBPF:

1. The MDSAP route, generally preferable: ANVISA is a founding regulatory participant in the Medical Device Single Audit Program (MDSAP) and accepts valid audit reports issued by MDSAP Auditing Organisations (AOs) for CBPF issuance without an ANVISA on-site inspection;

2. ANVISA on-site inspection: sites without MDSAP must undergo an on-site audit by ANVISA inspectors. Waiting times for initial inspections have historically been long and can often be measured in years in practice.

A CBPF is generally valid for two years, although industry practice under the MDSAP route can support validity of up to four years. It must be updated on expiry, when manufacturing sites change and in other relevant circumstances. Adding or changing a manufacturing site after Class III/IV registration also depends on publication of the GMP certificate under Article 24.

Two misconceptions need clarification. First, ISO 13485 certification alone does not establish compliance with Brazilian BPF. MDSAP audits incorporate both ISO 13485 and Brazil-specific requirements, which is why ANVISA accepts them. Second, although Class I/II notification does not require a CBPF, the LOA must still contain a BPF compliance declaration, so quality system responsibilities are not waived.

Q14. How should the technical dossier be structured, and can documents be in Chinese or English?

The technical dossier follows Chapter VII and Annex II of RDC 751/2022 and uses the IMDRF Table of Contents (ToC) structure. It is closely aligned with EU MDR technical documentation, with progressively detailed information by device class covering device description, safety and performance studies including risk management, biocompatibility and clinical evidence, manufacturing information and labelling. For Chinese manufacturers, this means technical documentation prepared for the EU or other markets can be reused extensively, creating regulatory synergies across multi-country submissions.

Language requirements differ by document under Article 10(9) and (10):

• Application forms, instructions for use or manuals, and label artwork must be in Portuguese;
• Other technical documents may be in Portuguese, Spanish or English;
• LOAs, CFSs and similar documents not issued in one of these three languages require a sworn translation.

For Class III/IV registration, the technical dossier is submitted with the application for review. Class I/II notification uses simplified documentation, but a genuine technical dossier must still exist and be retained by the holder. ANVISA can request it during a documentation review or inspection at any time.

5. Process, timelines, fees and regulatory reliance (Q15-Q18)

Q15. What are the steps in the registration process from project start to certification?

The standard process for a Class III/IV product is as follows:

• Determine classification: establish the class and pathway using the 22 rules, preferably with a written classification rationale;
• Settle the holding structure: select or establish the Brazilian holder and execute the LOA;
• Start GMP work: plan the MDSAP or ANVISA inspection route and obtain the CBPF or application receipt;
• Prepare documentation: the IMDRF ToC technical dossier, Portuguese labels and IFU, CFS and certification documents;
• Submit electronically: file through the ANVISA SOLICITA system and pay the TFVS fee by GRU;
• Review and deficiencies: undergo ANVISA technical review and respond to each Exigencia round;
• Publication and certification: the registration or notification is published in the DOU and becomes searchable on ANVISA’s website;
• IFU upload: upload the instructions for use to ANVISA’s document library within 30 days of publication under Article 33;
• Post-market maintenance: vigilance reporting, change management, renewals and UDI data maintenance.

Q16. What are the official and practical timelines?

• Notification (Class I/II): the standard statutory processing period is within 30 days of submission under Article 10(6). Including document preparation, translation and authentication, the overall process usually takes one to three months;
• Registration (Class III/IV): RDC 751/2022 sets no fixed review period; Article 10(2) simply requires review within the statutory periods and conditions. In practice, including GMP certification, dossier preparation and one or two deficiency rounds, the overall process commonly takes 8-14 months. Sites with MDSAP can significantly shorten the GMP stage;
• Acceleration initiative: ANVISA Call Notice No. 22/2025 opened an expedited route for pending applications marked aguardando analise where the product is identical to one already approved. Existing review conclusions are used to reduce waiting time, so applicants should check ANVISA’s database for approvals of the same product when planning their strategy.

Q17. What are the approximate costs, and how are official fees paid?

Brazilian registration-related costs fall into two categories:

• Official fees (TFVS): the health surveillance inspection fee applies to every application, including notifications, and is paid through a GRU federal payment slip. Rates depend on company size, with tiers for large, medium, small and micro enterprises, and on application type, including notification, registration, renewal, variation and GMP certification. Use ANVISA’s published fee table for the applicable year to confirm current amounts;
• Third-party costs: translation and sworn translation, notarisation and apostille, MDSAP audit fees, testing fees including INMETRO or ANATEL where applicable, registration holder services and post-market maintenance.

For budgeting, Class III/IV projects should separately allocate funds for GMP, registration and maintenance, and include the time cost of deficiency rounds. Class I/II projects are more cost-controlled, but the authentication chain and labelling compliance should never be omitted to reduce expense.

Q18. Can an existing FDA, CE or TGA approval provide access to a fast-track pathway?

A regulatory reliance pathway (Confianca Regulatoria) may be available. Under RDC 741/2022 and IN 290/2024, effective from 3 June 2024, applicants for Class III/IV medical device registration, including IVDs, can request Optimised Analysis. If the product has been approved by an Equivalent Foreign Regulatory Authority (AREE) recognised by ANVISA and is identical to the product proposed for Brazil in manufacturing characteristics, indications and intended use, evidence of the AREE approval can be submitted with the request.

ANVISA’s current list of recognised AREEs under IN 220/2024 comprises Australia’s TGA, Health Canada, the US FDA and Japan’s MHLW.

Three qualifications apply. First, Optimised Analysis does not alter ANVISA’s final decision-making authority or guarantee approval. Second, if the AREE itself granted its approval through an abridged procedure, Optimised Analysis is unavailable and the ordinary route applies. Third, EU CE marking is not on the AREE list: a CE certificate supports dossier preparation and evidence organisation but cannot directly trigger the reliance procedure.

In practice, ANVISA’s approvals still predominantly follow the ordinary process. Where timing is a priority, however, regulatory reliance can be considered as a potential route to earlier certification.

6. Maintaining registrations: renewal, variations and labelling (Q19-Q21)

Q19. How long is a registration valid, and what should be considered for renewal (Revalidacao)?

• Registration (Class III/IV): valid for 10 years from DOU publication, with successive renewals for the same period permitted under Article 11;
• Renewal window: Article 27(2) refers to RDC 250/2004, as amended by RDC 212/2018. Renewal must be filed between 12 and 6 months before expiry, neither earlier than 12 months nor later than 6 months. If ANVISA has not decided before expiry, the registration is automatically renewed by operation of the regulation, but ANVISA retains the power to review and cancel it later;
• Renewal documents: the manufacturer’s LOA and a valid GMP certificate. A GMP application receipt can likewise be used to start analysis under Article 27(3);
• Notification (Class I/II): no fixed validity period and exempt from renewal under Article 28, but variations must be reported when the product, holder or regulatory conditions change.

Q20. How are post-registration product changes (Alteracao) managed?

RDC 751/2022 divides changes into three categories under Article 16, with a detailed list in IN 74/2020:

• Changes requiring prior approval: major changes, such as design or manufacturing-site changes affecting safety and performance, require ANVISA approval before implementation and may be implemented only from the date of approval publication in the DOU under Article 21;
• Immediately implementable changes: moderate changes may be implemented once the application is submitted and must be published within up to 30 days after processing, whether or not ANVISA has completed its documentation review under Article 22. If inconsistencies are found, ANVISA may suspend sales, imports or use;
• Changes not requiring notification: low-risk changes, such as contact details, layout and non-technical adjustments, are controlled through the holder’s quality system and reflected in subsequent applications.

Two supporting rules are worth remembering. For inventory run-down, where a change creates inconsistent versions of finished products, packaging, labels or IFUs, packaging materials, labels and IFUs have a 120-day transition period from publication of the change, while finished products may be used until their expiry or shelf-life date under Articles 25 and 26. This transition does not apply to changes made to resolve a safety or performance problem. Changes arising from a field safety action or recall can also request priority analysis under Article 20.

Q21. What are the mandatory labelling and IFU requirements, and why must the IFU be uploaded to ANVISA’s website?

Labels must be in Portuguese and include the following under Article 47: the manufacturer’s name and address; the holder’s name and address; product identification and package contents; where applicable, a Sterile marking and sterilisation method; lot or serial number; manufacturing and expiry dates; single-use marking; storage, transport and handling conditions; special instructions for use; all warnings and precautions; the Technical Responsible Person’s name; and the ANVISA registration or notification number.

The IFU must accompany the package or state how it can be obtained, although Class I/II devices may be exempt from including a copy where safety is assured. Content covers intended use, side effects, compatibility with combinations, installation, maintenance and calibration, implantation risks, interference risks, handling of damaged sterile barriers, and reprocessing or resterilisation procedures, among other matters under Articles 46 and 48.

The IFU upload obligation appears in Articles 33-36. For newly registered or notified products and their variations, the IFU must be uploaded to ANVISA’s Medical Device Document Library within 30 days of DOU publication. If a change not requiring notification affects the IFU, the updated document must be uploaded within 180 days of implementation. The library displays only the latest version publicly, while historical versions are retained for reference. Failure to upload, or a mismatch between versions, can lead ANVISA to suspend sales, imports and use of the product.

Products on the mandatory certification list under the Brazilian Conformity Assessment System (SBAC), including certain electromedical devices, must also hold a conformity certificate issued by INMETRO or another designated body. Only products manufactured during the certificate’s validity period may be imported and sold under Article 12. Devices with wireless functions such as Wi-Fi, Bluetooth or cellular connectivity must separately obtain ANATEL type approval. These certifications are independent of ANVISA registration, and each applicable requirement must be satisfied.

7. Post-market obligations: vigilance, advertising and UDI (Q22-Q24)

Q22. What are the deadlines for adverse event reporting (Tecnovigilancia)?

Post-market vigilance reports in Brazil are submitted through NOTIVISA. The core rules in Articles 6-8 of RDC 67/2009 set deadlines according to event severity:

Where a field safety corrective action or recall is required, RDC 551/2021 governs notification, safety alerts to users, progress reports and closure reports. For Chinese manufacturers, the 72-hour deadline is a distinctive and strict Brazilian requirement that must be managed alongside the EU’s 2-calendar-day and US 5-working-day reporting windows. Only the Brazilian registration holder can submit the report. Manufacturers therefore need an internal service-level agreement requiring immediate escalation to the holder, because missing the deadline is itself a violation.

Q23. What restrictions apply to medical device advertising in Brazil?

Brazil does not require prior approval of device advertising, but the compliance boundaries are clear:

1. Precondition for promotion: the product must have completed registration or notification and been published in the DOU;

2. Consistency requirement: all marketing communications and advertising must strictly match the information submitted to ANVISA by the holder under Article 32 of RDC 751/2022. Claims may not exceed the registered intended use and indications or imply unregistered models or functions;

3. General legal constraints: advertising is also governed by Law No. 6,360/1976 and the Consumer Defence Code (CDC). The strict rules for medicinal product advertising in RDC 96/2008 are applied by analogy to devices, including prohibitions on promotional inducements and misleading representations;

4. Industry self-regulation: Brazilian medical device industry associations maintain codes of conduct, and the CONAR advertising self-regulatory system can investigate non-compliant advertisements.

Before releasing promotional materials such as websites, exhibition content, brochures and social media posts, a compliance review should compare every statement against the registered information.

Q24. What is the implementation status of UDI, and what should Chinese companies do?

Brazil’s UDI system was established by RDC 591/2021, effective from 10 January 2022 and amended by RDC 884/2024, with mandatory implementation phased in by risk class. The deadlines for UDI on labels, based on manufacturing date, are:

• Class IV: 10 July 2025, already in effect;
• Class III: 10 January 2026, already in effect;
• Class II: 10 January 2027;
• Class I: 10 January 2028.

Reusable devices generally have approximately two additional years before UDI must be directly marked on the device itself. Certain implants, including coronary stents, drug-eluting stents and hip or knee replacements, have been subject to earlier requirements since 20 June 2020.

A UDI consists of a UDI-DI, the model-level identifier, and a UDI-PI, the production identifier covering information such as lot number, serial number, expiry date or software version. Labels must carry both an automatic identification and data capture carrier (AIDC) and human-readable interpretation (HRI). Recognised issuing agencies include GS1, HIBCC and ICCBBA. Holders must also submit core data to ANVISA’s National UDI Database (SIUD). The Class III deadline has now passed and the Class II countdown is underway, so affected companies should incorporate UDI into label revisions and export production planning immediately.

8. IVDs, common pitfalls and selecting a compliance provider (Q25-Q27)

Q25. Which regulations apply to IVDs in Brazil?

IVDs are governed not by RDC 751/2022 but by RDC 830/2023, published on 6 December 2023 and effective from 1 June 2024. Their classification rules, notification and registration pathways, and labelling and IFU requirements form a separate framework. The essential safety and performance requirements of RDC 848/2024 also apply, and UDI requirements apply in parallel.

IVD companies should note that certain high-risk products may require analysis by INCQS, the National Institute for Quality Control in Health. These include immunohematology reagents related to blood screening; screening assays for hepatitis B, hepatitis C, syphilis, HIV, Chagas disease and HTLV; and self-tests for dengue, chikungunya and COVID-19. The associated timelines and costs should be assessed separately.

Q26. What are the most common pitfalls for Chinese manufacturers?

Ranked by how frequently they appear in project reviews, the following eight issues are the most typical:

• Misclassification: failure to document classification according to intended use and the 22 rules, resulting in the wrong pathway, rejection or a later requirement to reapply;
• Incomplete authentication chain: a CFS or LOA without an apostille, signed more than two years ago, or lacking the BPF compliance declaration; these three issues frequently trigger deficiency requests;
• Waiting for GMP before registration: overlooking that a GMP application receipt permits registration submission and the start of analysis under Article 14(2), wasting months through unnecessary sequential processing;
• Non-compliant labels: using European rather than Brazilian Portuguese, omitting holder or Technical Responsible Person information, or failing to show the ANVISA registration number;
• Late IFU upload to the document library: overlooking the 30-day post-approval window and creating a direct risk of sales suspension;
• Overlooking parallel certifications: failing to start INMETRO certification for electromedical devices or ANATEL approval for wireless devices alongside ANVISA registration, extending the overall timeline;
• Neglecting maintenance after approval: missing renewals, failing to report variations, reporting adverse events late or missing UDI labelling deadlines;
• Loss of control over the holding structure: placing the certificate with a distributor, creating dependence during channel changes and potentially requiring a new registration.

Q27. How should exporters to Brazil select a compliance service provider?

Due diligence should cover five dimensions:

• Whether the local entity is directly operated: a provider’s own Brazilian subsidiary and AFE, rather than subcontracted arrangements, affect holding stability and communication efficiency;
• Class III/IV track record: experience with registrations using MDSAP or BGMP pathways and the ability to manage GMP certification and registration in parallel;
• Technical capability: experience in IMDRF ToC dossier preparation, classification and clinical evidence organisation;
• Post-market system: team capacity for Portuguese-language vigilance reporting, change management, renewals, and UDI and document library maintenance;
• Commercial terms: transparent fees, a clear exit mechanism, and written arrangements for certificate ownership and transfer.

Annex: Principal Brazilian medical device regulations

Disclaimer: This article is based on publicly available Brazilian regulatory information current through October 2026 and is provided for general industry reference only. It does not constitute legal or regulatory advice. Regulations may be amended; for specific projects, consult ANVISA’s latest requirements, the texts published in the DOU and official interpretations.