Regulatory Affairs Consulting Services in Brazil

We help you stay on track with the right documentation, timelines, and strategies to meet ANVISA and other authority requirements, across product categories.

Services We Offer

Brazil-Specific Regulatory Affairs Solutions

Brazil is a high-potential market for companies looking to launch their products, but meeting the country’s regulatory requirements is key to a successful entry.

ANVISA (Agência Nacional de Vigilância Sanitária) is the regulatory authority of Brazil, regulates the registration and product approval in Brazil that are in compliance with local laws and regulations. ANVISA operates independently from the Ministry of Health and is authorized to issue legally binding decisions. ANVISA has gained global recognition as a Regulatory Reference Authority. As of 2016, it is a full member of the International Council for Harmonisation (ICH), and it has aligned many of its rules with global standards, though it still applies its own strict national procedures.

With an increased market potential, the regulatory laws are rigid with strict GMP compliance aligned to the Brazilian local laws. Artixio provides regulatory affairs consulting services to help companies to bring regulatory clarity and to enter the market without any hassle and delays.

Regulatory Authorities in Brazil

Authority	Area of Oversight	Role
ANVISA	All life sciences sectors	Reviews, authorizes, and monitors products including drugs, medical devices, cosmetics, nutritionals, and biologics.
MAPA	Veterinary & Agricultural Products	Regulates animal health products, veterinary medicines, and food of animal origin.
INMETRO	Medical Devices & Equipment	Certification body for regulated device classes requiring quality and safety labels.
CONCEA	Biologics & Research Use	Regulates use of animals in scientific research and supports ethical standards in preclinical trials.

Regulatory Affairs Lifecycle in Brazil

ANVISA follows a well-defined multi-step process for product approval and market entry with a set of regulatory requirements.

Step 1 - Pre-Submission Process

RDC – Specific Product Classification: The applications should be classified based on the ANVISA’s classification system, which is RDC (Collegiate Board Resolution or Resoluções da Diretoria Colegiada) specific which further determines the regulatory pathway of the product. The classification is done on the basis of intended use, risk class (for medical devices), composition and dosage form.
Appoint a Local Partner: Make sure to enter the market through a Brazil based local entity who holds a valid AFE (Business Operating Authorization or Autorização de Funcionamento de Empresa). They help with the complete process of product life cycle and acts as a Point of Contact (POC) between the company/manufacturer and the ANVISA.
Apply for company operation authorization (AFE). Also, initiate the process of GMP certification (CBPF) if manufacturing or importing is involved.

Step 2 - Prepare Technical Dossier

ANVISA uses a hybrid dossier compilation format and does not fully accept ICH CTD, integrating both administrative and technical modules. Dossiers should include:

All documents must be formatted and indexed according to IN 2/2020 or latest applicable standard. Submit the dossiers via Peticionamento Eletrônico, however, some categories still require hardcopy filing depending on the type of submission.

Step 3 - ANVISA GMP Inspection of Manufacturing Sites

The dossier is not reviewed until the foreign GMP certification (FDA, EMA) is not accepted by ANVISA or ANVISA conducts a direct site inspection in the facility and approves it. For products such as sterile drugs, biologics, and high-risk devices, it always requires direct site inspections.

Step 4 - ANVISA Technical Review and Exigências

ANVISA uses a centralized digital queue system (Fila Única) to submit the application. A formal request (Exigência Técnica) is sent by the regulatory authority in case of any additional requirements or data incompleteness, which requires a response within 120 days. If there is no response, the application could be closed or rejected.

Step 5 - Sanitary Registration and Product Launch

ANVISA issues a sanitary registration which is valid for 10 years (may vary with the type of product such as controlled substances or orphan drugs). Before launching the product in the market, the companies should follow the below:

Step 6 - Post Marketing Compliance Requirements

ANVISA requires companies to be regulatory compliant after the product is launched in the market. It includes:

Why Artixio for Brazil Regulatory Services?

FAQs

Q1. What is the role of ANVISA in regulatory approvals?

ANVISA is Brazil’s primary authority for regulating pharmaceuticals, medical devices, cosmetics, food supplements, and biologics. It oversees the safety, efficacy, labeling, and licensing of products before they enter the market.

Q2. Is a local representative required for registration in Brazil?

Yes, foreign companies must appoint a local MA holder or authorized representative to register and maintain product licenses.

Q3. What are the timelines of ANVISA GMP inspection?

ANVISA schedules a manufacturing site inspection about six months after receiving the inspection request. If the inspection is successful, the Good Manufacturing Practice (GMP) certificate is issued within 45 to 60 days of inspection.

Q4. Are global CTDs or dossiers accepted in Brazil?

While global formats are a starting point, dossiers must be adjusted to local structure and submitted in Portuguese.

Q5. Do medical devices need INMETRO certification before submission?

Yes, for certain classes of medical devices, INMETRO certification is a prerequisite and must be secured before or during the registration process.

Q6. How long is a CBPF (GMP certificate) valid in Brazil?

A CBPF is valid for two years (the validity varies depending on product type and risk). Initiate a new inspection request or updated documentation from recognized authorities for renewal.

Q7. What happens if there's a company ownership change after registration?

In this case, notify ANVISA and initiate a transfer of ownership petition which includes legal documentation, updated MAH information, and formal amendment of the Registro Sanitário.