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Brazil Authorized Representative Services
Brazil stands as one of the world’s largest and fastest-growing economies, with a GDP increase of 2.9% in 2023 and a promising outlook for continued expansion. However, entering this dynamic market requires navigating complex regulatory frameworks, particularly in the healthcare and cosmetics industries.
The Brazilian healthcare sector faces structural challenges, evolving technologies, and economic-industrial complexities, demanding compliance with stringent regulations. Meanwhile, the country’s booming cosmetics industry, the third largest globally, presents immense opportunities with a strong demand for personal care, makeup, and perfumery products.
Taevas Life Sciences offers comprehensive Brazil Authorized Representative services to help medical device, pharmaceutical, food, and cosmetic companies achieve seamless compliance and successful market entry in Brazil. Our expertise ensures adherence to ANVISA regulations, allowing you to focus on business growth while we handle the complexities of local representation.
Who is a Brazil Authorized Representative?
A Brazil Authorized Representative is a legally recognized entity, represented by an individual residing in Brazil, that serves as the official representative of foreign businesses in the country. Acting as an extended arm for international companies, they ensure seamless operations by handling regulatory compliance and business facilitation.
Why Choose Taevas for Brazil Authorized Representative?
When expanding into Brazil, partnering with the right Authorized Representative is crucial to navigating the complex regulatory landscape. Taevas Life Sciences brings years of expertise and a deep understanding of Brazil’s legal and market frameworks to support your business in a seamless market entry.
- Act as your Brazil Authorized Representative before health authorities, ensuring full compliance for product approvals.
- Serve as the liaison between your team and health authorities, handling all communications.
- Coordinate and attend health authority meetings as required.
- Submit product applications/dossiers for seamless market entry.
- Manage health authority fee payments with precision.
- Provide consistent follow-ups on submissions to keep projects on track.
- Address queries and secure approvals with expertise.
- Handle product lifecycle management, including variations and renewals.
- Trusted by 258+ global clients for regulatory compliance and market entry success.
- With extensive knowledge across 23 markets, we ensure seamless compliance with international regulations.
- Our strong relationship with global regulatory authorities expedites the approval process, facilitating quicker market access.
- We mitigate delays in market entry that can lead to financial losses.
- We minimize the risk of non-compliance, preventing costly recalls and penalties.
- We offer end-to-end support that encompasses all aspects of regulatory compliance, from product registration to market entry, distribution, warehouse & inventory management in global markets.
- We deliver customized strategies that address the unique regulatory needs of each market, ensuring optimal outcomes.
- Act as your Brazil Authorized Representative before health authorities, ensuring full compliance for product approvals.
- Serve as the liaison between your team and health authorities, handling all communications.
- Coordinate and attend health authority meetings as required.
- Submit product applications/dossiers for seamless market entry.
- Manage health authority fee payments with precision.
- Provide consistent follow-ups on submissions to keep projects on track.
- Address queries and secure approvals with expertise.
- Handle product lifecycle management, including variations and renewals.
- Trusted by 258+ global clients for regulatory compliance and market entry success.
- With extensive knowledge across 23 markets, we ensure seamless compliance with international regulations.
- Our strong relationship with global regulatory authorities expedites the approval process, facilitating quicker market access.
- We mitigate delays in market entry that can lead to financial losses.
- We minimize the risk of non-compliance, preventing costly recalls and penalties.
- We offer end-to-end support that encompasses all aspects of regulatory compliance, from product registration to market entry, distribution, warehouse & inventory management in global markets.
- We deliver customized strategies that address the unique regulatory needs of each market, ensuring optimal outcomes.
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Brazil Authorized Representative Services for Medical Devices
Entering the Brazilian market with medical devices requires strict adherence to the regulatory framework set by the National Health Surveillance Agency (ANVISA). Taevas Life Sciences offers comprehensive Brazil Authorized Representative services to help medical device companies navigate these regulations and ensure compliance at every step.
Roles & Responsibilities:
Obtaining necessary licenses, including Authorization of Operation (AFE) from ANVISA.
Registration or notification of medical devices with ANVISA, which is mandatory for Class III/IV devices and optional for Class I/II.
Managing product recalls, if necessary, ensuring consumer safety and compliance with ANVISA’s guidelines.
Ensuring Good Manufacturing Practices (GMP) Certification for higher-risk devices.
Staying updated on regulatory changes and providing ongoing compliance support for the entire lifecycle of your product.
Brazil Authorized Representative Services for Cosmetics
Brazil’s personal care and beauty industry is governed by strict regulatory standards to ensure the safety and efficacy of cosmetic products. The National Health Surveillance Agency (ANVISA) is the primary regulatory authority responsible for overseeing the approval, registration, and compliance of cosmetics in Brazil.
Expanding your cosmetic products into Brazil requires navigating a highly regulated environment. Taevas Life Sciences provides expert Brazil Authorized Representative services to help cosmetic brands comply with local regulations set by the ANVISA. We ensure that your products meet all legal and safety requirements, allowing you to focus on growth in this dynamic market.
Roles & Responsibilities:
Obtaining necessary licenses, including an Authorization of Operation (AFE) from ANVISA.
Registration or notification of cosmetics, with registration required for Grade 2 products and notification for Grade 1 products.
Ensuring compliance with local good manufacturing practices (GMP) guidelines for safety and quality.
Managing imports and customs clearance to ensure smooth product delivery into Brazil.
Handling product recalls, if necessary, in accordance with ANVISA’s regulations.
Ensuring label compliance, making sure that all packaging and labeling meet Brazilian standards and guidelines.
Brazil Authorized Representative Services for Food & Dietary Supplements
- Food Supplements
- Novel Foods and Ingredients
- Foods with Functional or Health Claims
- Food for Infants and Young Children
- Enteral Nutrition Products
- Food Contact Materials with New Technologies (e.g., recycled PET-PCR food grade)
Roles & Responsibilities:
Obtaining necessary licenses, including Authorization of Operation (AFE) from ANVISA.
Managing communication, notification, and registration of food and dietary supplements according to IN 281/2024.
Ensuring compliance with all regulatory requirements, including category-specific regulations for food and dietary products.
Managing imports and customs clearance when required for the smooth introduction of your products into the Brazilian market.
Staying updated on regulatory changes and ensuring your products remain in compliance as laws evolve.
Brazil Authorized Representative Services for Pharmaceuticals
The Brazilian pharmaceutical industry is governed by ANVISA, which oversees the regulation of various types of medicines, including:
- New Medicines
- Innovator Medicines
- Similar Medicines
- Generic Medicines
- Biological Medicines
- Notified Medicines
- OTC Drugs
- Potentized Medicines
- Specific Medicines
- Herbal Medicines
- Medicinal Gases
- Radiopharmaceuticals
Each classification has its own specific regulatory requirements, making compliance essential for market success.
Navigating Brazil’s pharmaceutical regulations requires a comprehensive understanding of the local legal framework and a strong partnership with a trusted Authorized Representative. Taevas Life Sciences offers expert services to help pharmaceutical companies comply with the National Health Surveillance Agency (ANVISA) and ensure a smooth market entry.
Roles & Responsibilities:
Holding the necessary local and federal licenses, including the Local Health Authority (HA) and ANVISA licenses, to conduct importer and distributor activities, as well as operate warehouses and QC laboratories.
Ensuring compliance with Law 6360/76 and Decree 8077/2013, which govern the registration of medicines in Brazil.
Submitting registration applications to ANVISA to obtain the required registration certificate for your product.
Managing post-approval changes (variations), ensuring that ANVISA is informed of any updates or modifications.
Assisting with adverse event reporting and product recalls, ensuring swift actions in line with regulatory requirements to protect public health.
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Our global presence
Taevas helps global life sciences innovators with global expansion strategies to connect with audiences worldwide and make it accessible for millions of people around the world.
Our global presence
Taevas helps global life sciences innovators with global expansion strategies to connect with audiences worldwide and make it accessible for millions of people around the world.
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Frequently Asked Questions
Who is a Brazilian Legal Representative (LR/MAH)?
The Brazilian local representative or marketing authorization holder is a locally registered entity with the ANVISA, authorized to submit registration applications on behalf of foreign manufacturers and serve as a liaison between ANVISA and the foreign manufacturer.
Which are the prerequisites to be a Brazilian Legal Representative (LR/MAH)?
It is necessary to be a company with a national registration of legal entities (CNPJ) and for that the Brazilian company needs to have a legal representative person resident in Brazil. It is also necessary to have the heath authority licenses granted in order to be a MAH of the products subjected to the health surveillance in Brazil. Licenses needs to follow the rule CVS 01 of 2024 that discipline, within the scope of the State Health Surveillance System – Sevisa, the health licensing of establishments of health interest and provides related measures.
Which products import would require a LR/MAH?
LR/MAH is required for any foreign company that wants to launch its products in Brazil.
How I will be benefitted to appoint you/Taevas as my legal representative instead of my existing distributor in Brazil?
Foreign manufacturers have the option to designate importers as their LR. Nonetheless, opting for an independent LR service provider is strongly advised as their legal representative in the Brazilian market. Choosing an independent agency offers the manufacturer the flexibility to appoint multiple importers under their LR for different categories of products to be registered.
Is it possible to appoint more than one LR/MAH for the same product?
It is depending on the registration category of the product since a product registered as a new product with a brand name cannot be registered as a new product with the same brand name by another LR/MAH. So, in this case it is necessary to request the transfer of titularity in order to allow the Foreign Manufacturer to point out a different LR/MAH. On another hand, if the product already registered will be registery in another registration category as a generic product the foreign company can have another LR/MAH for the same product.
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