Brazil's pharmaceutical market is valued at USD 34.66 billion in 2024, expected to reach USD 48.6 billion by 2030. With 93,700 pharmacies operating nationwide and R$ 158.4 billion in retail pharmacy revenue, Brazil represents the largest healthcare software market in Latin America.
Brazilian Healthcare Software Market
Key Regulatory Bodies
- ANVISA: National Health Surveillance Agency - regulates pharmaceuticals and medical devices
- SUS: Sistema Único de Saúde - largest government-run public healthcare system globally (220 million covered)
- SBIS: Brazilian Society of Health Informatics - certifies EHR systems
- CFM: Federal Council of Medicine - co-certifies healthcare software
Market Leaders
- Raia Drogasil (RD Saúde): Largest in Latin America, 3,000+ pharmacies, 15.5% market share
- Pague Menos: 1,650 stores, strong in North/Northeast
- Coopidrogas equivalent: Large cooperative networks
- 50,000+ independent pharmacies
Local Brazilian Competitors
Pharmacy Software
Hospital Management Systems
ANVISA Regulatory Requirements
Software as Medical Device (RDC 657/2022)
- Classification rules per Annex I of Resolution RDC 751/2022
- Design verification documentation
- Cybersecurity assessment requirements
- Adopted from European MDR standards
Digital Submission Requirements (2025)
- SEI Platform: Mandatory for all new submissions
- eCTD Tools: Required for compliant dossier preparation
- Electronic Adverse Event Reporting
Traceability and Serialization
- Unique identification codes and serial numbers required
- Detailed data submission at supply chain stages
- Non-compliance: fines and product recalls
- Regular inspections and audits
SUS Integration Requirements
RNDS (National Health Data Network)
Decree No. 12,560/2025 launched RNDS as the SUS data integration platform:
- FHIR mandated as national interoperability standard
- 1.4 billion vaccine registries
- 74 million COVID/Monkeypox exam results
- 84.4 million primary care encounters
Conecte SUS / Meu SUS Digital
Central platform storing lifetime health data:
- Medical history tracking
- Vaccination records
- Test results
- Medication history
- Transplant queue position
Farmácia Popular Program Integration
- Up to 90% discount on prescribed drugs
- Free hypertension, diabetes, and asthma medications
- Software must integrate with this program
SNGPC Controlled Substance Requirements
Sistema Nacional de Gerenciamento de Produtos Controlados - mandatory return in 2025:
Required Software Capabilities
- Automated SNGPC reporting to reduce human error
- Storage of dispensing data for controlled substances
- Prescription data capture from qualified professionals
- Invoice tracking for supplier purchases
- Real-time inventory management
- XML data format for ANVISA submissions
Compliance Roles Required
- Responsável Legal (RL): Official business representative
- Responsável Técnico (RT): Licensed pharmacist for technical compliance
- Representante Legal para SNGPC (RepL): Specific SNGPC representative
Data Requirements
- Batch numbers
- Expiration dates
- Quantities
- Input/output movements
- Compliance with RDC 586/2022
BRL Pricing Overview
Market Context
- Retail pharmacy market: R$ 158.4 billion (2024)
- Top 5 chains: 33% market share (vs 81% in US)
- Independent pharmacies: 17% market share
PharmaPOS for Brazil
Payment Methods - PIX Dominance
PIX Statistics
- 175+ million users (May 2025)
- 93% of Brazilian adult population
- 62% use it as most frequent payment method
- 47% of all financial transactions (end 2024)
- Over 6.2 billion monthly transactions
PIX Cost Advantage
PIX 2025 New Features
- Pix por Aproximação (NFC): Launched February 28, 2025
- Pix Automático (recurring): June 16, 2025 - ideal for software subscriptions
- Pix Parcelado (installments): September 2025
Boleto Bancário
- Traditional barcode payment slips
- Payable at banks or convenience stores
- Still relevant for B2B and unbanked populations
- Boleto Flash confirms payments within one hour
SBIS Certification
Partnership between Brazilian Society of Health Informatics and Federal Council of Medicine (since 2002):
Certification Categories
- Clinic/outpatient EHR
- Individual practice EHR
- Inpatient EHR
- Emergency care EHR
- Information security
- Telehealth/teleconsultation
Voluntary but considered first criteria for reliable local systems.
NF-e (Nota Fiscal Eletrônica) Integration
- Mandatory for B2B transactions
- XML file with up to 450 data points
- Digital certificate (e-CNPJ) required
- Real-time SEFAZ validation
- Fines up to 100% invoice value for non-compliance
- New VAT codes (CBS, IBS, IS) mandatory from January 2026
Why Choose PharmaPOS for Brazil
PharmaPOS offers advantages for Brazilian pharmacies:
Key Benefits
- SNGPC-Ready: Controlled substance tracking and XML exports
- Offline Operation: Works without internet - critical for rural Brazil
- BRL Pricing: One-time payment, no ongoing subscription fees
- Portuguese Interface: Full Portuguese language support
- PIX Integration: Native support for Brazil's dominant payment method
- NF-e Compatible: Electronic invoicing ready
- Farmácia Popular: Subsidy program integration
Digital Health Strategy 2020-2028 (ESD28)
Public initiative guiding digital health actions through 2028:
- RNDS as premier digital platform for innovation
- SEIDIGI (Secretariat of Information and Digital Health) coordination
- UBS+Digital Project for telehealth primary care
Getting Started
PharmaPOS provides complete pharmacy management for Brazilian pharmacies with SNGPC compliance and offline capability. HospitalOS offers comprehensive hospital management ready for RNDS integration.
Contact us for a demonstration with Portuguese language support and BRL pricing.
