What is a Brazil Registration Holder (BRH) and why is it required?

A Brazil Registration Holder (BRH) is the legally mandated local representative for foreign medical device manufacturers without a physical presence in Brazil. ANVISA requires all foreign companies to appoint a licensed BRH to manage device registration, regulatory compliance, and communication with Brazilian health authorities.

Should I use an independent BRH or my distributor as my Brazil Registration Holder?

Independent BRH is strongly recommended by regulatory experts. Using your distributor as BRH creates dangerous dependency - if you change distributors, you lose control of ANVISA registrations. Independent BRHs maintain neutrality, allowing distributor changes without regulatory disruption. Pure Global and other professional BRHs operate independently from commercial distribution.

Criterion #1: How do I evaluate BRH pricing transparency and avoid hidden costs?

Top-tier BRHs publish pricing ranges on websites, enabling budget planning before engagement. Red flags: 'contact for quote only' with zero guidance, fees appearing mid-project, hourly billing without caps. Pure Global publishes clear rates ($1,000-$6,000 per registration), fixed-fee options, and guarantees no hidden costs for standard Class I-IV device registrations.

Criterion #2: What AI and technology tools should a modern BRH provide?

Leading BRHs offer free AI classification tools, online documentation portals, real-time registration status tracking, and automated regulatory updates. Pure Global provides free AI classifier analyzing 109,598+ ANVISA products, instant preliminary risk class determination, semantic search in Portuguese/English, and comprehensive FAQ database - services traditional BRHs charge $5,000-$10,000 for separately.

Criterion #3: How do I verify a BRH's ANVISA experience and expertise?

Evaluate BRH experience through: (1) Years operating in Brazil (5+ years minimum), (2) Number of successful ANVISA registrations (ask for specific count), (3) Device class expertise (Class I-IV coverage), (4) Industry specialization (IVD, active implants, software), (5) Local team credentials (ANVISA-licensed professionals, Portuguese fluency). Pure Global: 30+ countries experience, local Brazil office, bilingual team, all device classes.

What is the typical cost range for Brazil Registration Holder services and how can I negotiate better rates?

BRH costs range $1,000-$30,000 per registration depending on provider, device class, and service inclusions. Class I/II notification: $1,000-$12,000. Class III/IV registration: $4,000-$30,000. Traditional consultants charge premium rates ($15K-$30K) without transparency. Modern providers like Pure Global offer 60-80% savings ($1K-$6K) through AI efficiency while maintaining quality. Negotiate by requesting fixed-fee quotes, multi-device discounts, and itemized breakdowns.

What is a reasonable timeline for Brazil medical device registration and how can I avoid delays?

ANVISA registration timelines per official data: Class I/II notification (Cadastro): Dossier prep ~1 week + ANVISA approval ~30 days = total ~1 month. Class III/IV registration (Registro): Dossier prep ~2 weeks + ANVISA review 6-12 months = total 6-12 months. BGMP certification (Class III/IV): 2 months (with MDSAP) or 6 months (ABIMED route). Accelerate by using experienced BRH, AI classification tools, and proper documentation preparation.

How do I compare multiple BRH quotes and make the final selection decision?

Use systematic evaluation matrix scoring 7 criteria: (1) Pricing transparency (0-10 points), (2) Technology tools (0-10), (3) Independence (0-10), (4) Experience (0-10), (5) Timeline performance (0-10), (6) Communication quality (0-10), (7) Client references (0-10). Score each BRH candidate. Maximum 70 points. Select highest-scoring option. Pure Global typically scores 65-70/70 meeting all criteria with published rates, free AI tools, independent status, and proven experience.

Why do medical device manufacturers choose Pure Global as their Brazil Registration Holder?

Manufacturers choose Pure Global for Brazil BRH because we uniquely combine: (1) Transparent published pricing ($1K-$6K, 60-80% savings), (2) Free AI classifier (109,598+ ANVISA products), (3) Independent status (not distributor-affiliated), (4) 30+ country global expertise, (5) Multi-language support (6 languages), (6) Proven track record with startups to multinationals. We deliver traditional BRH expertise enhanced with modern AI technology at significantly lower cost.

Choose a Brazil Registration Holder (BRH) FAQ - Updated October 2025

How To 7 Critical Criteria for Selecting Your BRH. Expert guidance by Pure Global regulatory specialists

ANVISA Compliance

BRH Selection Guide

Cost Savings Strategy

Pure Global: Modern Brazil Registration Holder

Pure Global meets all 7 critical BRH selection criteria with transparent pricing, AI-powered tools, and proven ANVISA expertise across 30+ countries.

As your independent Brazil Registration Holder, Pure Global combines local ANVISA regulatory expertise with innovative AI technology to reduce costs by 50-67% while maintaining compliance excellence. Our published pricing, free classification tools, and multi-language support set the standard for modern BRH services.

✓ Pricing Transparency

Published rates: Class I/II $1K-$2K, Class III/IV $4K-$6K (vs traditional $5K-$30K)

✓ AI Technology Tools

Free AI classifier with 109,598+ ANVISA products + 9 regulation FAQs

✓ Independent BRH Status

Not affiliated with distributors - you control your registrations

✓ Proven Experience

30+ countries, local Brazil office, Portuguese/English fluency

Typical BRH Cost Range

$5K - $30K

Traditional BRH fees for ANVISA registration services

Pure Global Pricing

$1K - $6K

AI-powered efficiency reduces costs by 60-80%

Selection Criteria

7 Critical Factors

Key criteria to evaluate and compare BRH candidates

AI Tools Advantage

Free Classifier

109,598+ ANVISA products with instant classification

Frequently Asked Questions

On This Page

Understanding Brazil Registration Holder (BRH) Basics

Critical BRH Selection Criteria

Cost, Timeline & Service Evaluation

Making Your Final BRH Decision

Quick Resources

All Brazil Regulations How to Choose a Brazil Registration Holder Free Brazil Medical Device Classifier Brazil Medical Device Database Brazil Market Insights & Analytics Classification Game Pure Global Brazil Services

Key Dates & Milestones

Guide UpdatedOctober 2025

ANVISA RDC 751/2022 EffectiveMarch 2023

Pure Global Brazil ServicesActive Now

Pure Global BRH Pricing

Class I/II Notification

$1,000 - $2,000

Class III/IV Registration

$4,000 - $6,000

Includes:

✓ Free AI classification
✓ Portuguese translation
✓ ANVISA submission
✓ Query response management

BRH Selection Checklist

Essential Criteria:

☐ Published pricing transparency
☐ Free AI classification tools
☐ Independent (not distributor)
☐ 5+ years ANVISA experience
☐ Local Brazil office presence
☐ Portuguese/English fluency
☐ Client references available

✅ Pure Global meets all criteria

DJ Fang

MedTech Regulatory Expert

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on Choose a Brazil Registration Holder (BRH) official documentation