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Regulatory Excellence

Navigate ANVISA with 30 Years of Proven Expertise

Complete regulatory support from product classification to post-market compliance. Our BRHS (Brazil Registration Hosting Service) through BIHS enables foreign manufacturers to register products while maintaining full ownership and control.

100%

Approval Rate 2025

2,600+

Devices Registered

600+

Clients Served

30

Years Experience

Regulatory Excellence

ANVISA Registration is too Complex?

Brazil's ANVISA regulatory framework aligns with world-leading agencies like FDA and CE. If your company already holds registrations in reference markets, your Brazilian registration journey will be smooth when guided by an experienced partner.

World-Class Standards

ANVISA follows international best practices aligned with FDA, CE Mark, and ISO standards. Your existing regulatory documentation provides a strong foundation for Brazilian approval.

Proven Pathways

With 30 years of experience and 2,600+ successful registrations, we've established efficient processes that leverage your existing certifications to accelerate ANVISA approval.

Strategic Navigation

The right regulatory partner transforms complexity into opportunity. We handle classification, documentation, certifications, and compliance so you can focus on market strategy.

Continuous Support

From initial submission through post-market obligations, our team ensures ongoing compliance with ANVISA requirements, technovigilance protocols, and regulatory updates.

Our Services

Complete Regulatory Solutions

From initial classification to ongoing compliance management, we handle every aspect of Brazilian regulatory requirements.

ANVISA Registration

ANVISA Registration

Expert navigation of notification and registration pathways with proven track record of approvals.

  • Product classification and risk assessment
  • Technical documentation preparation
  • Notification process (3-6 months)
  • Full registration process (12-18 months)
  • Regulatory strategy and planning
BIHS Hosting

BIHS Hosting Service

Brazil Import Healthcare Solutions enables foreign manufacturers to register products while maintaining ownership.

  • Legal holder for ANVISA registration
  • You retain economic ownership
  • Full control over commercial strategy
  • Technovigilance and compliance management
  • UDI and traceability support
Certifications

Multiple Certifications

Beyond ANVISA, we coordinate all required certifications for your product category.

  • GMP/CBPF manufacturing certification
  • INMETRO metrology certification
  • ANATEL telecommunications approval
  • INCQS quality control certification
  • ISO and international standards alignment
BIHS Hosting Service

Register Products Without Establishing a Brazilian Entity

Our Brazil Registration Hosting Service (BRHS) through BIHS enables international manufacturers to access the Brazilian market efficiently.

How BIHS Hosting Works

BIHS (Brazil Import Healthcare Solutions) acts as the legal registration holder with ANVISA, allowing you to register medical devices in Brazil without establishing a local subsidiary or hiring a local responsible technical manager.

You maintain complete economic ownership and control over your products, pricing, distribution strategy, and market approach. We handle the regulatory compliance, technovigilance, and all ANVISA-related obligations.

Key Benefits:

  • No need to establish Brazilian legal entity
  • You retain full ownership of registration
  • Control your commercial strategy completely
  • Proven compliance and risk management
  • 30+ years regulatory expertise backing you
  • Seamless integration with Alliance Club distribution
BIHS Partnership
Our Process

ANVISA Registration Process

A proven six-phase approach that ensures regulatory approval while optimizing timeline and investment.

1

Product Classification & Assessment

Comprehensive review of product specifications, intended use, and clinical characteristics to determine correct ANVISA classification and registration pathway (notification vs. full registration). Includes commercial proposal approval and project kickoff.

2-4 weeks
2

Documentation Preparation

Compile and prepare all required technical documentation, clinical evidence, quality certificates, manufacturing compliance proof, and labeling requirements according to ANVISA standards.

15 days - 4 weeks
3

Certification Coordination

Parallel processing of required certifications (GMP/CBPF, INMETRO, ANATEL, INCQS) based on product requirements. These certifications are prerequisites for ANVISA submission. Schedule audits, coordinate inspections, manage certification timelines.

Varies by certification type
4

ANVISA Submission

Submit complete registration dossier through BIHS as legal holder. Track submission status, respond to ANVISA queries, provide additional documentation as requested.

Notification: 3-6 months | Registration: 12-18 months
5

Approval & Publication

Receive ANVISA approval and registration number. Product published in official registry. Coordinate UDI registration and DOU publication if required. Delivery of complete technical dossier E-book for your records.

1-2 weeks post-approval
6

Post-Market Compliance

Ongoing technovigilance, adverse event reporting, product tracking, regulatory renewals, and compliance monitoring. BIHS handles all ongoing ANVISA obligations.

Continuous
Certifications We Handle

Beyond ANVISA: Complete Certification Support

Medical devices in Brazil often require multiple certifications beyond basic ANVISA registration.

🏥

GMP/CBPF

Good Manufacturing Practices certification for manufacturers. Required for Class III and IV devices. Plant inspection and quality system audit.

📏

INMETRO

National Institute of Metrology certification for measurement devices, diagnostic equipment, and products requiring calibration standards.

📡

ANATEL

Telecommunications certification for devices with wireless connectivity, Bluetooth, WiFi, or any RF transmission capability.

🔬

INCQS

Quality control certification from National Institute of Quality Control in Health for specific product categories requiring additional validation.

30
Years Experience
2,600+
Devices Registered
600+
Clients Served
100%
Approval Rate 2025
15+
Product Categories

Ready to Navigate ANVISA Successfully?

Partner with 30 years of proven regulatory expertise. BIHS hosting service enables efficient market entry while you maintain full control.

Apply for Partnership WhatsApp: +55 21 3950-0580