Brazil Product Registration Certification
Important Notes
- ANVISA as the Central Regulatory Authority: All pharmaceuticals, medical devices, health products, cosmetics, foods (including supplements), and sanitizers require marketing authorization from ANVISA, involving complex and stringent processes.
- Stringent Regulation of Dietary Supplements & Functional Foods: These products are strictly regulated under specific food regulations. All functional health claims must be based on pre-approved ingredient lists and supported by robust scientific evidence.
- Brazilian Local Registration Holder Requirement: A foreign manufacturer must appoint a legal entity established in Brazil as the Registration Holder, assuming full lifecycle legal responsibility for the product.
- Mandatory Portuguese Documentation & Labeling: All technical dossiers, labels, and instructions must be in Brazilian Portuguese. Labeling regulations are extremely detailed, with non-compliance risking registration failure or penalties.
- Localized Good Manufacturing Practice Inspections: ANVISA conducts rigorous and frequent GMP inspections for both domestic and foreign manufacturing sites, with standards considered among the world’s toughest.
- Deep Integration with MERCOSUR Technical Regulations: As a key driver of MERCOSUR, Brazil’s regulations for devices and cosmetics are deeply harmonized with regional resolutions, making it central to any regional strategy.
Brazil Specific Requirements
- Massive but High-Barrier Primary Latin American Market: Brazil offers the largest healthcare consumption market in Latin America, coupled with some of the world’s most complex, stringent, and costly regulatory hurdles.
- Unified Health System as Market Foundation & Major Payer: The public SUS is the largest single purchaser of medicines and essential health products, its tender rules profoundly shaping market dynamics and pricing.
- Strong Preference for Local Clinical Trial Data: For innovative products, ANVISA typically requires local clinical trial data involving Brazilian populations, often becoming the most time-consuming step for market entry.
- Mature & Booming Demand for Beauty & Wellness Products: Brazil has one of the world’s largest cosmetics and beauty markets, with immense demand for cosmeceuticals, skincare, and supplements, albeit in a hyper-competitive landscape.
- Regional Regulatory Beacon & Manufacturing Hub: ANVISA is a benchmark for regulatory capacity in Latin America, and Brazil’s advanced chemical and pharmaceutical industry makes it a key regional manufacturing and export center.
Medical Devices Registration
Regulatory Requirements
- Product Registration (Cadastro/Registro de Produto)
- Risk-based classification system (Class I-IV) according to RDC 185/2001
- Brazilian Good Manufacturing Practices (BGMP) certification for Class II-IV devices
- Complete technical documentation and test reports
- Portuguese labeling and instructions for use
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing per ISO 10993 (where applicable)
- Electrical safety and electromagnetic compatibility testing
- Risk management documentation according to ISO 14971
Main Process
- Product classification determination
- Technical documentation preparation
- BGMP certification acquisition
- ANVISA review submission
- Product registration certificate acquisition
Registration Timeline
8-24 months
Official Fees
BRL 5,000 - 80,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
ANVISA
Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária)
Responsible for medical devices, cosmetics, dietary supplements, herbal medicines, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Brazil, operating under national regulatory framework. Regulatory scope includes: medical device registration, cosmetic notifications, dietary supplement filings, herbal medicine registration, and more.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-IV) and applicable registration pathway according to ANVISA RDC 185/2001
BGMP Certification
Obtain Brazilian Good Manufacturing Practices certificate (mandatory for Class II and above devices)
Technical Documentation Preparation
Prepare comprehensive technical documentation including test reports and Portuguese labeling
ANVISA Application Submission
Submit product registration application through Brazilian local representative (Detentor)
Post-Market Surveillance
Establish technical complaints, adverse event reporting, and vigilance system as per ANVISA requirements
Cosmetic Products Registration
Regulatory Requirements
- Cosmetic Notification (Notificação de Cosméticos)
- Ingredient formulation safety assessment
- Portuguese labeling requirements compliance
- Good Manufacturing Practices certification
- Restricted ingredients compliance
- Product safety data and toxicological information
- Microbiological quality specifications
- Stability study documentation
- Manufacturing process description
- Quality control procedures
Main Process
- Ingredient formulation assessment
- Label review preparation
- Cosmetic notification submission
- GMP system establishment
- Technical documentation maintenance
Registration Timeline
3-7 months
Official Fees
BRL 500 - 5,000
Service Fees
$6,000 - $18,000
Regulatory System Overview
ANVISA
Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária)
Responsible for medical devices, cosmetics, dietary supplements, herbal medicines, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Brazil, operating under national regulatory framework. Regulatory scope includes: medical device registration, cosmetic notifications, dietary supplement filings, herbal medicine registration, and more.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and ensure compliance with ANVISA permitted lists and usage limits
Portuguese Labeling Review
Prepare Portuguese labeling compliant with ANVISA requirements including claims and warnings
Cosmetic Notification
Submit notification through Brazilian Cosmetic Notification System (Sistema de Notificação de Cosméticos)
GMP System Implementation
Establish Good Manufacturing Practices system and quality control procedures
Technical Documentation Maintenance
Maintain complete product technical file and update notifications as required
Dietary Supplements & Herbal Medicines Registration
Regulatory Requirements
- Dietary Supplement Notification (Notificação de Suplementos Alimentares)
- Herbal Medicine Registration (Registro de Fitoterápicos)
- Simplified registration for traditional herbal medicines
- Ingredient compliance assessment and maximum usage limits
- Scientific evidence requirements for health claims
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Traditional use evidence (for herbal medicines)
- Portuguese labeling compliance
Main Process
- Product classification confirmation (supplement/herbal medicine)
- Ingredient and dosage compliance assessment
- Scientific evidence preparation (if applicable)
- ANVISA notification or registration submission
- Labeling and claims review
Registration Timeline
2-14 months
Official Fees
BRL 300 - 25,000
Service Fees
$4,000 - $30,000
Regulatory System Overview
ANVISA
Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária)
Responsible for medical devices, cosmetics, dietary supplements, herbal medicines, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Brazil, operating under national regulatory framework. Regulatory scope includes: medical device registration, cosmetic notifications, dietary supplement filings, herbal medicine registration, and more.
Dietary Supplements & Herbal Medicines Registration Process
Regulatory Classification
Determine product classification as dietary supplement or herbal medicine under Brazilian regulatory framework
Ingredient Compliance Assessment
Evaluate ingredient compliance with ANVISA permitted lists and dosage limitations
Regulatory Pathway Determination
Dietary supplements - notification system; Herbal medicines - registration system
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, Portuguese labeling, and supporting documentation
ANVISA Submission
Submit notification or registration application through local representative