Brazil ANVISA Local Representative Services

Compare ANVISA local representative providers for Brazil. Request quotes and choose a partner for Brazil market entry and regulatory support.

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Compare Brazil ANVISA Local Representative Services Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

NorteAccess Solutions

NorteAccess Solutions provides essential county services for Del Norte County, California. Access information on health, elections, public safety, and more.

NorteAccess Solutions serves as the primary point of contact for Del Norte County, California, offering a wide range of public services. Residents can find information and access resources related to Health, Elections, Payments & Taxes, and Public Safety. The county government is committed to providing accessible information and services to its constituents. For inquiries or comments, residents can utilize the contact form on the county website, ensuring their questions are routed to the appropriate department. The main county office is located at 981 H Street, Crescent City, CA 95531.
HQ: Crescent City, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Onboarding + annual retainer
Starting from: USD 9,000
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NorteReg Serviços

The Departamento de Estradas de Rodagem (DER) is a Brazilian state agency responsible for the management and maintenance of state highways in Paraná. They provide services related to traffic, fines, and transportation.

The Departamento de Estradas de Rodagem (DER) is the state agency responsible for the planning, construction, maintenance, and administration of the road network in the state of Paraná, Brazil. Operating under the state government, DER plays a crucial role in ensuring the safety and efficiency of state highways, facilitating transportation and logistics within the region. Their services extend to managing traffic operations, processing traffic fines, and overseeing intermunicipal passenger transport. The agency also provides information on road conditions, publishes official notices, and handles various administrative processes related to road infrastructure and usage. Citizens can access information on traffic updates, fines, and other related services through their official website. DER is committed to improving the state's transportation infrastructure, undertaking projects such as highway duplications and bridge constructions to enhance connectivity and economic development. Their work directly impacts the daily lives of residents and the broader economic activity of Paraná.
HQ: Curitiba, BR
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 48 hours
Onboarding time: 14–60 days
Pricing model: Per project
Starting from: USD 6,500
Product Categories: Traffic Fines, Intercity Passenger Transport, Roads
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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BrasilAccess Solutions

BrasilAccess Solutions is a provider of services for the Brazilian market, focusing on local representation and ANVISA compliance. They aim to facilitate business operations within Brazil.

BrasilAccess Solutions specializes in offering comprehensive services tailored for businesses looking to establish or expand their presence in Brazil. Their expertise includes providing local representation and navigating the complexities of ANVISA registration and compliance. They are dedicated to ensuring a smooth and secure process for their clients, acting as a bridge between international businesses and the Brazilian regulatory landscape. BrasilAccess Solutions is committed to facilitating secure connections and operations within the Brazilian market.
HQ: Brasília, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Retainer
Starting from: USD 15,000
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SolLiaison Solutions

Child Welfare Information Gateway provides trusted resources on child welfare, supporting children, youth, and families. They offer publications, research, and learning tools for professionals and caregivers.

The Child Welfare Information Gateway is a service of the Children's Bureau within the U.S. Department of Health and Human Services. Their mission is to strengthen families and support children and youth by providing access to a wide range of free and trusted resources. They cater to child welfare professionals, service providers, relatives caring for children, and parents. They offer publications, research, and learning tools selected by experts to support positive outcomes for all children, youth, and families. The Gateway focuses on kin-first culture and lived experience, aiming to equip individuals with the necessary tools to make a difference in their communities. While they do not have the authority to intervene in personal matters, they provide extensive resources for finding help, reporting child abuse and neglect, and understanding various aspects of child welfare, including casework practice, funding, laws, policies, and safety. They also offer resources in Spanish and provide support through their website, live chat, and phone. Their services are designed to be a connection point for reliable information, helping to improve the safety, permanency, and well-being of children through leadership, support for necessary services, and partnerships with states, tribes, and communities.
HQ: Washington, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Product Categories: Child Welfare, Family Support, Youth Services
Features: Portuguese Support
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BrasilQuality Partners

Volvo Group is a leading global supplier of transport and infrastructure solutions, offering trucks, buses, construction equipment, and marine/industrial engines. They focus on sustainable transport and innovation.

Founded in 1927, Volvo Group is a prominent global supplier of transport and infrastructure solutions. With approximately 102,000 employees across 14 brands and operations in nearly 180 markets, they provide a wide range of products and services including trucks, buses, construction equipment, and power solutions for marine and industrial applications. Volvo Group is committed to shaping the future of sustainable transport through innovation in areas like renewable fuels, hydrogen fuel cells, and battery electric technologies. Their headquarters are located in Gothenburg, Sweden, and they serve diverse customer and market segments worldwide.
HQ: Gothenburg, SE
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Product Categories: Trucks, Buses, Construction Equipment
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SolReg Partners

J.W. Speaker designs and manufactures innovative, high-performance LED lighting technology for automotive, powersports, transport, and industrial products. They specialize in custom LED solutions for OEMs and offer a vast network of partners.

J.W. Speaker is a leader in developing and manufacturing innovative, high-performance LED lighting technology for a wide range of applications including automotive, powersports, transport, and industrial products. They specialize in partnering with Original Equipment Manufacturers (OEMs) to provide custom LED lighting solutions that deliver enhanced performance and stunning aesthetics. With a commitment to quality and innovation, J.W. Speaker designs, manufactures, and assembles its products in Germantown, Wisconsin. They are certified to rigorous automotive standards including ISO 9001, ISO 14001, ISO 26262, and IATF 16949, ensuring their products meet the highest industry requirements. The company offers a comprehensive catalog of LED lighting products, including headlights, light bars, fog lights, trail lights, and more, catering to various vehicle types and categories. They also provide extensive resources for customers, including FAQs, troubleshooting guides, and installation instructions, to ensure optimal product performance and customer satisfaction.
HQ: Germantown, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Onboarding + annual retainer
Starting from: USD 9,000
Product Categories: Headlights, Light Bars, Fog Lights
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AuroraBridge Group

AuroraBridge Group offers a simple, user-friendly website solution specifically designed for bridge clubs. Easily manage club websites with features like automatic results upload and competition management.

AuroraBridge Group provides an intuitive platform for bridge clubs, county associations, and bridge teachers to create and maintain their own websites. No prior web design knowledge is required, as the system is designed for ease of use, with most essential features included as standard. Hundreds of bridge clubs worldwide utilize BridgeWebs for their online presence. The service simplifies website management through features such as automatic results upload, hand of the week, an editor for news articles, an automatic map page, and a forms submit feature for competitions. It also supports competition and ladder tracking, and allows for the inclusion of your own pictures. Admin access can be shared securely using passwords, making it quicker and more accurate for club administration. BridgeWebs offers a free trial period, allowing clubs to evaluate the benefits before committing. Beyond the trial, the service is available at an affordable annual cost, with no additional charges for club members. The only requirement is a PC with a browser and internet connection.
HQ: Curitiba, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 48 hours
Onboarding time: 14–60 days
Pricing model: Per project
Starting from: USD 6,500
Product Categories: Websites for Bridge Clubs, Bridge Club Websites, County Association Websites
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NorteBridge Group

NorteBridge Group is a provider featured in the br_local_rep directory, offering resources and updates through KERA News.

NorteBridge Group is listed in the br_local_rep directory. Their presence is evidenced by the KERA News website, a public media organization serving North Texas. KERA News covers a range of topics including Health & Wellness and Arts Access, and provides daily updates through newsletters and radio schedules. While specific services offered by NorteBridge Group are not detailed, their association with KERA News suggests a focus on community information and engagement within the North Texas region.
HQ: São Paulo, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Retainer
Starting from: USD 15,000
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VerdeReg Partners

VerdeReg Partners is the European Union's diplomatic service, responsible for implementing the EU's Common Foreign and Security Policy. They promote peace, prosperity, and security globally.

The European External Action Service (EEAS), operating as VerdeReg Partners, serves as the European Union's diplomatic arm. Established in 2011, the EEAS is tasked with executing the EU's Common Foreign and Security Policy, aiming to foster peace, prosperity, security, and advance European interests worldwide. Led by the EU High Representative for Foreign Affairs, the EEAS shapes the EU's global standing. It coordinates with EU institutions to address foreign policy priorities, including civilian and military planning and crisis response. The service also manages EU Special Representatives in various countries and regions. VerdeReg Partners plays a crucial role in representing the EU and its citizens globally through its Diplomatic Representations. These entities build networks and partnerships, contributing to the EU's diplomatic relations with nearly all countries. The EEAS has been involved in numerous overseas operations since 2003, encompassing both civilian and military missions.
HQ: Brussels, BE
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Features: Portuguese Support
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VerdeBridge Group

VerdeBridge Group provides services related to land management, tribal consultation, and dispute resolution, focusing on collaboration and sustainable practices for public lands.

VerdeBridge Group is dedicated to the sustainable management of public lands, offering expertise in areas such as land use planning, tribal consultation, and collaborative action and dispute resolution. They work to foster strong relationships with tribal nations, honoring their sovereignty and upholding trust responsibilities. The organization provides resources and guidance for effective conflict prevention and resolution, aiming to improve collaborative decision-making processes. They also engage in contracting and financial assistance programs, supporting projects that align with their mission and the priorities of the Department of the Interior. VerdeBridge Group emphasizes a commitment to serving communities and ensuring the health, diversity, and productivity of public lands for present and future generations. Their services are designed to support economic growth while respecting traditional uses and environmental stewardship.
HQ: Recife, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
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RioBridge Solutions

RioBridge Solutions offers expert services for your directory listing needs on br_local_rep. We focus on extracting and presenting your core provider profile information effectively.

RioBridge Solutions specializes in enhancing provider profiles for directory listings, specifically for platforms like br_local_rep. Our service focuses on identifying and extracting the essential core fields that define your provider profile. We ensure that your key information is accurately represented, making it easier for potential clients or partners to find and understand your offerings within the directory. Trust RioBridge Solutions to optimize your presence and highlight your core strengths.
HQ: Campinas, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Onboarding + annual retainer
Starting from: USD 9,000
Product Categories: Software, Consultoria, Serviços de TI
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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AuroraReg Serviços

AuroraReg Serviços, operating as the Departamento de Estradas de Rodagem (DER) in Brazil, manages state highways, traffic updates, and related services for the Paraná region.

AuroraReg Serviços, identified as the Departamento de Estradas de Rodagem (DER) for the br_local_rep directory, is the state agency responsible for the administration and maintenance of roads in Paraná, Brazil. The DER provides essential services related to state highways, including traffic updates, information on transit infractions, and management of inter-municipal passenger transport. Their operations encompass the planning, construction, and upkeep of the state's road infrastructure. Citizens can access information on traffic conditions, pay traffic fines, and obtain certifications related to road usage. The agency also handles licensing for charter services and provides contact points for public inquiries and complaints. The DER's commitment extends to ensuring the safety and efficiency of the road network, as evidenced by ongoing projects like the duplication of the Rolândia Bypass and the construction of the Guaratuba Bridge. They offer various resources, including forms, manuals, and transparency reports, to facilitate public access to information and services.
HQ: Curitiba, BR
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 48 hours
Onboarding time: 14–60 days
Pricing model: Per project
Starting from: USD 6,500
Product Categories: Multas de Trânsito em Rodovias Estaduais, Transporte Intermunicipal de Passageiros, Licenças de Fretamento
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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VerdeAccess Advisors

VerdeAccess Advisors provides expert guidance for navigating complex financial landscapes, specializing in strategic advisory services for businesses and organizations.

VerdeAccess Advisors is a dedicated consultancy focused on delivering strategic financial and operational advice. We empower our clients to achieve their objectives through tailored solutions and in-depth market analysis. Our expertise spans various sectors, ensuring comprehensive support for your business's growth and sustainability. We are committed to fostering long-term partnerships built on trust and measurable results, helping you access new opportunities and overcome challenges in today's dynamic economic environment.
HQ: Recife, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Retainer
Starting from: USD 15,000
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AnvisaLife Consultoria

AnvisaLife Consultoria is a Brazilian consultancy specializing in regulatory affairs and health services. They are listed in the br_local_rep directory.

AnvisaLife Consultoria is a specialized consultancy firm based in Brazil, focusing on navigating the complex landscape of regulatory affairs within the health sector. Their expertise is particularly valuable for businesses seeking to understand and comply with Brazilian health regulations, likely including those overseen by ANVISA (Agência Nacional de Vigilância Sanitária). As a listed entity in the br_local_rep directory, AnvisaLife Consultoria serves as a local representative, offering guidance and support to clients operating within or looking to enter the Brazilian market. Their services are designed to streamline processes related to health product registration, compliance, and market access, ensuring that clients can operate effectively and legally. The GOV.BR website, a primary source for Brazilian government services and information, was reviewed. While the website provides a broad range of public services and information, specific details about AnvisaLife Consultoria's operations, such as their exact location, contact information, or a detailed service catalog, were not directly extractable from the provided page content. The site emphasizes government services, citizen information, and national programs, indicating the general regulatory environment in which AnvisaLife Consultoria operates.
HQ: Brasília, BR
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Features: Portuguese Support
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AnvisaLife Serviços

AnvisaLife Serviços specializes in neurosurgery and spine implants, offering a comprehensive range of products and services. They are dedicated to innovation and leadership in their field.

AnvisaLife Serviços, operating since 2002, is committed to being a leader and innovator in the commercialization of products and services for the neurosurgery and spine implant segments. Their offerings include solutions for spinal procedures, featuring advanced systems like the Timberline LLIF lateral access fusion system with integrated modular titanium plates and PEEK-OPTIMA® interbody spacers. The company has expanded its product line to include solutions from ZimmerBiomet, such as ROI-C and MOBI-C for cervical spine procedures, and ROI-A and MOBIDISC-L for lumbar spine. AnvisaLife Serviços provides a wide array of products categorized under Lumbar, Cervical, and Spine Accessories, including stand-alone cages, cervical and lumbar interbody devices, and percutaneous systems. Their product catalog also features specialized items like the ZimVie | Mobi-C® and various anterior and posterior cervical systems, as well as lumbar and thoracolumbar systems designed to enhance surgical outcomes and patient care.
HQ: Campinas, BR
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Product Categories: Coluna, Lombar, Cervical
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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BrasilLiaison Serviços

BrasilLiaison Serviços offers specialized services for the Brazilian market, acting as a local representative for businesses seeking to navigate the region. They focus on facilitating connections and ensuring compliance within Brazil.

BrasilLiaison Serviços is dedicated to providing essential support for companies looking to establish or strengthen their presence in Brazil. As a local representative ('br_local_rep'), they bridge the gap between international businesses and the Brazilian market, offering expertise in navigating local regulations and business practices. Their services are designed to streamline operations and ensure smooth integration within the Brazilian business landscape. By leveraging their understanding of the local environment, BrasilLiaison Serviços aims to be a trusted partner for clients seeking to expand their reach and achieve their objectives in Brazil. They are committed to facilitating secure and effective business engagements.
HQ: Florianópolis, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Onboarding + annual retainer
Starting from: USD 9,000
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AuroraQuality Consultoria

AuroraQuality Consultoria is a Brazilian consultancy providing expert services for your local representation needs.

AuroraQuality Consultoria specializes in offering tailored consultancy services to businesses seeking a strong local presence in Brazil. As a dedicated partner for the br_local_rep directory, we focus on delivering high-quality solutions that align with your strategic objectives. Our team is committed to understanding your unique requirements and providing the expertise necessary to navigate the local market effectively. We aim to be your trusted advisor, ensuring your business thrives through informed decision-making and efficient operations within the Brazilian landscape.
HQ: Curitiba, Brazil
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 48 hours
Onboarding time: 14–60 days
Pricing model: Per project
Starting from: USD 6,500
Features: Portuguese Support
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NorteReg Group

NorteReg Group offers car rental services through Budget, providing various options for local, long-term, group, and one-way rentals. They focus on delivering competitive rates and a convenient rental experience.

NorteReg Group partners with Budget Car Rental to offer a comprehensive suite of car rental services tailored for the br_local_rep directory. Whether you need a vehicle for local travel, extended periods, group events, or one-way trips, NorteReg Group aims to provide accessible and efficient solutions. They emphasize providing competitive pricing, including special offers and a best rate guarantee, ensuring customers receive value for their rental needs. The services extend to various rental types, including long-term and monthly rentals, as well as specialized options for meetings and groups. Budget's commitment to a user-friendly experience is reflected in their online booking system, which allows for easy reservation management and access to potential discounts. Customers can explore options for different rental scenarios, from daily local use to more extensive travel plans. NorteReg Group, through Budget, strives to meet diverse customer requirements with a focus on reliability and customer satisfaction. The brand highlights its commitment to offering a seamless rental process, from booking to vehicle return, making it a convenient choice for directory users.
HQ: Recife, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 24 hours
Onboarding time: 10–45 days
Pricing model: Retainer
Starting from: USD 15,000
Product Categories: Car Rental
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NorteLiaison Advisors

Nardis Advisors LLC is a fee-only, fiduciary financial advisor based in Scarsdale, NY, specializing in services for US expats, particularly those with ties to Israel.

Nardis Advisors LLC is a fee-only, fiduciary financial advisory firm based in Scarsdale, NY. They specialize in providing financial guidance to US expats, with a particular focus on individuals with assets or interests in Israel. Their services address the complex financial challenges faced by US expats, including navigating international tax laws, cross-border investments, and estate planning. They offer a complimentary initial assessment, estate planning diagnostic sessions, and social security guidance from an expert. Their expertise ensures compliance, helps minimize taxes, and optimizes wealth strategies for clients living abroad. Nardis Advisors LLC aims to help clients secure their legacy and manage their assets across both the US and Israel, ensuring a comfortable and stress-free retirement.
HQ: Scarsdale, US
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English, Spanish
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Product Categories: Financial Planning, Estate Planning, Cross-border Investments
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SolReg Serviços

The Prefecture of Itaitinga is the municipal government body responsible for local administration and public services in Itaitinga, Ceará, Brazil. It focuses on managing city operations, public policies, and citizen services.

The Prefeitura de Itaitinga serves as the central administrative body for the municipality of Itaitinga, located in the state of Ceará, Brazil. It is responsible for the execution of local government functions, including the management of public services, urban development, and the implementation of municipal policies. The institution oversees various secretariats and departments dedicated to different areas of public administration, such as education, health, infrastructure, and finance. The official website provides information on municipal news, official documents, public tenders, and services available to citizens. Key initiatives and information often highlighted include public notices, legal dispositions, and updates on the city's development and governance. The Prefeitura aims to foster transparency and citizen engagement through its online presence and public services.
HQ: Itaitinga, BR
Jurisdictions: BR
Countries: BR
Languages: Portuguese, English
Response SLA: 72 hours
Onboarding time: 21–90 days
Pricing model: Custom pricing
Starting from: USD 4,500
Product Categories: Government Services, Public Administration, Municipal Services
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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EU Boost

EU Boost is an initiative by the European Commission to simplify digital rules, foster innovation, and support EU businesses in scaling and saving administrative costs.

EU Boost, a project by the European Commission, aims to streamline digital regulations across the EU. The initiative focuses on making compliance easier for businesses by simplifying rules related to data, cybersecurity, and AI. It is part of a broader 'Digital Package' designed to boost innovation and help EU companies scale their operations more effectively. This effort includes strategies like the Data Union Strategy and proposals for European Business Wallets, all contributing to a more agile and supportive digital environment for businesses within the European Union.
HQ: EU
Languages: English
Product Categories: Data, Cybersecurity, AI
Services: Cadastro, Registro
Features: Portuguese Support
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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

HQ: Boston, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Product Categories: IVD, SaMD, Implants
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

HQ: London, UK
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Product Categories: IVD, SaMD, Implants
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

HQ: San Francisco, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Product Categories: IVD, SaMD, Implants
Services: Cadastro, Registro
Features: Portuguese Support, Local License
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Comprehensive Buyer's Guide

1. Who Needs a Brazil ANVISA Local Representative?

Foreign manufacturers placing medical devices on the Brazilian market must typically appoint a Brazilian local representative registered with ANVISA.

This requirement applies to:

  • Non-Brazilian medical device manufacturers entering the Brazilian market
  • Foreign manufacturers needing cadastro (registration) or registro (registration)
  • Manufacturers requiring Brazilian regulatory representation
  • Companies needing ANVISA support for market entry

Note: The local representative must be established in Brazil and assumes regulatory responsibility. Portuguese language support is typically required for labeling, documentation, and regulatory communications.

2. What Services Are Typically Included?

Brazil ANVISA local representative services typically include:

  • Regulatory representation: Acting as your local representative for ANVISA compliance
  • Cadastro/Registro support: Assisting with ANVISA registration applications
  • ANVISA communication: Serving as contact point with ANVISA
  • Adverse event reporting: Handling incident reporting to ANVISA
  • Post-market surveillance: Supporting PMS activities and compliance
  • Translation support: Some providers offer Portuguese translation services
  • Compliance support: Ensuring ongoing compliance with ANVISA requirements

3. What Affects Pricing?

Local representative pricing varies based on:

  • Device classification: Class III/IV devices typically cost more than Class I/II
  • Regulatory pathway: Registro is more complex than cadastro
  • Portfolio size: Number of devices and device families
  • Service scope: Basic local representative vs. comprehensive regulatory support
  • Translation needs: Portuguese translation requirements (can be significant)
  • Contract terms: Annual retainer vs. per-device fees

4. How to Choose a Provider

Key factors to consider:

  • Brazilian establishment: Verify they're established in Brazil
  • Device class experience: Confirm experience with your device classifications
  • Regulatory expertise: Verify understanding of ANVISA requirements, cadastro/registro pathways
  • ANVISA experience: Assess track record with ANVISA consultations and registrations
  • Translation capabilities: Check if they offer Portuguese translation support
  • Response times: Verify SLA for ANVISA communications and incident reporting
  • Additional services: Check if they offer registration support or broader consulting

Frequently Asked Questions

Q1: What is a Brazil ANVISA local representative?

A Brazil ANVISA local representative is a legal entity established in Brazil that acts on behalf of foreign manufacturers to fulfill regulatory obligations for placing medical devices on the Brazilian market under ANVISA (Agência Nacional de Vigilância Sanitária) regulations. The local representative serves as the manufacturer's regulatory representative and is responsible for ensuring devices comply with Brazilian medical device regulations. Key responsibilities include: registering devices with ANVISA (obtaining cadastro or registro depending on device classification), maintaining device registrations and ensuring ongoing compliance, handling regulatory communications with ANVISA, managing post-market surveillance and adverse event reporting, ensuring proper labeling and documentation compliance (often requiring Portuguese translation), and supporting regulatory inspections. The local representative must be established in Brazil and assumes regulatory responsibility. For foreign manufacturers, appointing a Brazilian local representative is typically required to place devices on the Brazilian market.

Q2: Is a local representative required for all devices in Brazil?

Yes, foreign manufacturers placing medical devices on the Brazilian market typically need a local representative, though the specific requirements depend on device classification and regulatory pathway. ANVISA classifies devices into Classes I, II, III, and IV, and each class has different registration requirements: Class I devices typically require cadastro (registration), while Class II, III, and IV devices require registro (registration with more detailed review). The local representative is involved in both pathways. Some low-risk devices may have simplified requirements, but most medical devices require a local representative. The local representative must be established in Brazil and must be able to fulfill regulatory responsibilities. When evaluating providers, confirm they understand the requirements for your specific device classifications and can handle the appropriate regulatory pathway (cadastro vs. registro).

Q3: What affects Brazil ANVISA local representative pricing?

Brazil ANVISA local representative pricing varies based on several factors: device classification (Class I, II, III, IV—higher risk classes typically cost more due to increased regulatory requirements), regulatory pathway (cadastro vs. registro—registro is more complex and costly), portfolio size (number of devices and device families), service scope (basic local representative services vs. comprehensive regulatory support including ANVISA registration, PMS, vigilance, etc.), translation needs (Portuguese translation of labeling, IFU, documentation—can be a significant cost component), ANVISA interaction requirements (some devices require more ANVISA communication and support), surveillance needs (post-market surveillance, adverse event reporting), change management (frequency of device changes requiring regulatory notifications), and contract terms (annual retainer vs. per-device fees, setup fees, etc.). Some providers also charge for: ANVISA registration support, translation services (which can be substantial), and ongoing compliance monitoring. Request detailed pricing breakdowns. Local representative services can range from a few thousand USD per year for simple devices to tens of thousands for complex Class III/IV portfolios with extensive translation needs.

Q4: What should I prepare when onboarding with a Brazil ANVISA local representative?

To onboard with a Brazil ANVISA local representative, prepare: device information (device names, classifications, intended use, GMDN codes), technical documentation (summaries of technical files, evidence of safety and performance, clinical data if applicable), quality management system information (ISO 13485 certificates, QMS overview), manufacturing information (manufacturing sites, quality controls), labeling and IFU (current labeling, instructions for use—will likely need Portuguese translation), existing registrations (if devices were previously on market in Brazil, ANVISA registration numbers, etc.), and company details (manufacturer information, contact details, etc.). The local representative may also request: risk management files, clinical evaluation summaries, post-market surveillance data, and any previous ANVISA correspondence. For Brazilian market entry, you'll likely need Portuguese translations of key documentation (labeling, IFU, some technical documentation). More complete documentation can speed up onboarding, typically 4-8 weeks for straightforward cases. The local representative will review your documentation to assess regulatory requirements and provide a quote. Some providers offer pre-onboarding assessments to identify requirements early.

Q5: How do I compare Brazil ANVISA local representative providers effectively?

When comparing Brazil ANVISA local representative providers, evaluate: Brazilian establishment (verify they're established in Brazil and can provide Brazilian address and contact details), device class experience (confirm experience with your specific device classifications, especially Class III/IV devices), regulatory pathway expertise (understanding of cadastro vs. registro pathways, ANVISA processes), ANVISA relationship (experience with ANVISA consultations, track record of successful registrations), vigilance and PMS capabilities (adverse event reporting, post-market surveillance), translation capabilities (if you need Portuguese translation support for labeling, documentation—this is often a significant component), response times (SLA for ANVISA communications, change notifications, incident reporting), additional services (some providers offer broader regulatory consulting, ANVISA registration support, etc.), contract terms (flexibility, termination clauses, fee structures), and references (ask about their largest clients, track record, client testimonials). Also consider: their understanding of your industry and device types, their ability to scale support as your portfolio grows, and whether they offer bundled services (local representative + translation + regulatory consulting) which can be cost-effective.

Q6: What is the difference between cadastro and registro in Brazil?

Cadastro and registro are different regulatory pathways in Brazil. Cadastro is a registration process typically for Class I devices (lowest risk) and involves notification to ANVISA with basic documentation. Registro is a more rigorous registration process for Class II, III, and IV devices, involving detailed review of technical documentation, clinical data (for higher risk devices), and quality management system. The local representative handles both processes, but registro is more complex and time-consuming. Registro typically takes 6-18 months or longer depending on device classification and ANVISA review, while cadastro can be completed in 2-4 months. The local representative you choose should have experience with the appropriate pathway for your devices. Most providers support both cadastro and registro, but verify their experience with your specific regulatory pathway and device classifications.

Q7: Do I need Portuguese translation for ANVISA local representative services?

Yes, Portuguese translation is typically required for Brazil ANVISA local representative services. Key areas requiring Portuguese: labeling and IFU (device labels and instructions for use must be in Portuguese), regulatory submissions (ANVISA submissions, registration applications, etc. are typically in Portuguese), correspondence with ANVISA (regulatory communications are in Portuguese), adverse event reporting (reports to ANVISA must be in Portuguese), and some technical documentation (certain technical documentation may need Portuguese translation or summaries). Many local representative providers offer translation services as part of their package or as an additional service. Translation can be a significant cost component, especially for complex devices with extensive documentation. When evaluating providers, clarify: whether translation is included, what documents need translation, translation quality and review processes, and translation costs. Some manufacturers handle translation separately, while others prefer providers who offer integrated local representative + translation services for convenience and consistency.

Q8: How long does Brazil market entry take with a local representative?

Brazil market entry timelines vary significantly based on device classification and regulatory pathway: Class I devices (cadastro) typically take 2-4 months, Class II devices (registro) typically take 6-12 months, Class III devices (registro) typically take 12-18 months, and Class IV devices (registro) can take 18-24 months or longer. Factors affecting timeline include: ANVISA review capacity (ANVISA's review times can vary significantly—some periods have longer backlogs, especially for registro submissions), Portuguese translation requirements (translation of labeling, IFU, and key documentation can add 2-4 weeks, and quality review of translations is critical for ANVISA acceptance), ANVISA consultation processes (pre-submission meetings with ANVISA can add 1-2 months but may significantly speed up review by clarifying requirements upfront), Brazilian market entry specifics (understanding of cadastro vs. registro pathways, ANVISA-specific documentation formats, and Brazilian regulatory nuances), ANVISA relationship factors (local representatives with established ANVISA relationships may achieve faster review times through better communication and understanding of ANVISA processes), and detailed timeline breakdowns (device classification and risk level, completeness of technical documentation, need for clinical data for higher risk devices, quality of documentation preparation by the local representative, and need for multiple ANVISA interactions). The local representative can provide more specific timelines based on your devices, regulatory pathway, and current ANVISA processing times. Early engagement with a qualified local representative can help identify requirements, plan the registration strategy, and potentially reduce overall timelines by avoiding common pitfalls. Some providers offer expedited services, though this typically incurs additional fees and may not significantly reduce ANVISA review times.

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Provider Comparison Table

Provider CoverageKey Features Languages Response SLA
NorteAccess Solutions BR Request quote Portuguese, English 24h
NorteReg Serviços BR Request quote Portuguese, English 48h
BrasilAccess Solutions BR Request quote Portuguese, English 24h
SolLiaison Solutions BR Request quote Portuguese, English 72h
BrasilQuality Partners BR Request quote Portuguese, English 72h
SolReg Partners BR Request quote Portuguese, English 24h
AuroraBridge Group BR Request quote Portuguese, English 48h
NorteBridge Group BR Request quote Portuguese, English 24h
VerdeReg Partners BR Request quote Portuguese, English 72h
VerdeBridge Group BR Request quote Portuguese, English 72h

Sources & Official Guidance

Last Updated: 2026-02-04
Reviewed by: Cruxi Regulatory Affairs Team
Cruxi - Regulatory Compliance Services