Brazil Medical Device Registration Cost 2026: BRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison

How Much Does It Cost to Register a Medical Device in Brazil in 2026?

For a single foreign-manufactured device entering Brazil in 2026, expect a 3-year all-in budget of roughly USD 6,000–14,000 for a Class I/II notification and USD 9,000–35,000 for a Class III/IV registration, excluding ANVISA government fees, BGMP audit costs, INMETRO/ANATEL testing, and clinical evidence preparation. The wide range is not driven by ANVISA — government fees are published and predictable. It is driven almost entirely by how your Brazilian Registration Holder (BRH) bills you.

Three pricing models dominate the BRH market today, and the difference between the cheapest and most expensive can exceed 4x over three years for the same scope of work:

BRH Pricing Model	Year 1 Cost (Class II, 1 device)	Year 1 Cost (Class III, 1 device)	3-Year Total (Class II)	3-Year Total (Class III)
Hourly billing	$5,000–$10,000	$15,000–$30,000	$11,000–$18,000	$25,000–$45,000
Registration fee + lower annual	$4,000–$8,000	$8,000–$15,000	$7,000–$15,000	$14,000–$30,000
Flat all-inclusive annual fee	$2,000–$3,000	$3,000–$4,500	$6,000–$9,000	$9,000–$13,500

Government fees (ANVISA notification BRL 1,406, registration BRL 8,510, BGMP BRL 72,805) are the same regardless of which BRH you pick. Your BRH bill is where you actually have leverage. This guide is about how to use it.

Skip to Your Scenario

• Single Class II device, pre-revenue startup: Read Scenario A first — flat fee saves $7,000 in Year 1 cash.
• Single Class III device entering Brazil: Read Scenario B — Year 1 burden under hourly is 71% of 3-year cost.
• Multi-device portfolio (3+ devices): Read Scenario C — tier discounts compound dramatically.
• Already have a BRH and want to switch: Skip to the BRH Switching Playbook.
• Issuing an RFP this week: Skip to the RFP Template and 8 questions to ask.
• Want to validate the numbers: Read the Named Provider RFP Comparison.

Why BRH Pricing Is Where Brazil Budgets Win or Lose

Brazil requires every foreign manufacturer to appoint a Brazilian Registration Holder — a legal entity in Brazil that holds the ANVISA notification or registration on the manufacturer's behalf, signs filings, issues letters of importation for each shipment, manages modifications and renewals, files BGMP for Class III/IV devices, and serves as ANVISA's point of contact for vigilance and inspections.

The BRH is not optional. It is also not a one-time cost. The relationship runs for as long as your device is on the Brazilian market, which under the Class III/IV registration pathway is up to 10 years per cycle and effectively indefinite for Class I/II notifications. So unlike a 510(k) consulting engagement that ends when FDA clears the device, a BRH is a recurring vendor relationship — meaning small differences in pricing model compound enormously over the device life.

This is also one of the few line items in international registration where the buyer has real negotiating leverage, because:

• The scope of work is well-defined and standardized (notifications, registrations, IUL, modifications, renewals, UDI).
• Multiple firms can perform the same statutory role.
• Switching is possible (with friction) but not impossible.
• ANVISA's fee schedule is public, so the BRH cannot mark up government fees opaquely.

The catch: most BRH pricing is not published. You have to issue an RFP, sign an NDA, and compare proposals where every firm has a different scope inclusion list. That is exactly the comparison this article is designed to short-circuit.

The Three BRH Pricing Models, Decoded

Model 1: Hourly billing ("charge by hour")

The default model for small-to-mid regulatory firms in Brazil and the historical industry standard. Scope is captured in a Statement of Work; everything outside scope (including most "small" requests like an extra letter of importation) is billed at hourly rates that typically run $125–$375/hour depending on tier:

Consultant Tier	Brazil Hourly Rate (2026)	Typical Work
Tier 1 — senior regulatory strategist	$315–$375/hr	RDC strategy, ANVISA escalations, regulatory disputes
Tier 2 — regulatory specialist	$235–$285/hr	Dossier preparation, exigência responses
Tier 3 — associate / documentation	$125–$170/hr	Translations, IUL letters, file maintenance

(Source: MedDeviceGuide Medical Device Regulatory Consulting Hourly Rates by Region.)

Why buyers choose hourly: flexibility, perceived control, ability to use the BRH only when needed.

Why hourly is bad for buyers in practice:

• No incentive to be efficient. Every hour the BRH spends is revenue. There is no economic reason to optimize a process or reuse a template.
• Surprise invoices. "Quick check with ANVISA" becomes 4 hours. Translation review becomes 6 hours. The bill arrives 60 days after the work.
• Scope creep is invisible until it bills. A modification to update a labeling change can be 2 hours or 20 — you find out after.
• Disincentive to communicate. Every email, every status update, every clarification call is potentially billable, so you ask fewer questions and end up with worse outcomes.
• Year 1 cash flow shock. First-year work (filing, BGMP coordination, translations, initial IULs) is front-loaded by definition and frequently 3–5x the steady-state annual hours.

A typical Class III hourly engagement for a single device runs $15,000–$30,000 in Year 1 and $3,000–$8,000/year thereafter, with significant variance based on how many exigências (technical clarifications) ANVISA issues.

Model 2: Registration fee + lower annual maintenance

The dominant model for mid-to-large BRH service firms today. Buyer pays a one-time setup/registration fee plus a smaller recurring annual fee. Scope is bundled but each "extra" is an itemized add-on.

Typical structure:

Component	Class I/II	Class III/IV
One-time setup fee	$1,500–$3,000	$2,500–$5,000
Initial registration filing	$2,000–$4,000	$4,000–$10,000
Annual maintenance fee	$1,500–$3,000	$3,000–$6,000
Per-modification fee	$500–$2,000	$1,500–$5,000
Per-IUL fee	$50–$500	$50–$500
BGMP filing	included or $1,000–$2,000 extra	$1,500–$4,000
Renewal filing (every 10 years for Class III/IV)	n/a	$2,000–$6,000

The trap: the marketing message is "low annual fee," but Year 1 actual spend is usually $4,000–$15,000 because every registration triggers setup + filing + BGMP + initial IULs simultaneously.

Where this model fails buyers:

• Year 1 cash flow shock is structural. All major one-time fees fire in the same calendar year you have not yet started selling.
• Modifications are unbounded. A regulatory environment as active as Brazil's (RDC 751 implementation, RDC 848/2024 GSPR alignment, RDC 884/2024 UDI deadlines, AREE/regulatory reliance pathways) generates 1–4 modification filings per device per year for active products. At $1,500/each, that is a $2,000–$6,000/year invisible tax.
• IULs scale with imports. Some firms charge per IUL letter ($300–$500). A high-volume distributor that ships monthly pays $3,600–$6,000/year just in administrative letters.
• Renewal cliff. At Year 10, the Class III/IV renewal triggers another $2,000–$6,000 fee window most buyers forget to budget.

Model 3: Flat all-inclusive annual fee

A newer pricing model where the BRH charges a single annual fee that includes the initial filing, all modifications, all IULs, all translations, all UDI submissions, and (for Class III/IV) the BGMP filing and renewal. The same number every year, year 1 to year N.

This model has two structural advantages:

1. The fee curve is flat instead of front-loaded. Year 1 cost equals Year 2 cost equals Year 3 cost. The pre-revenue period is no longer cash-flow-hostile.
2. The BRH's incentives align with yours. Once you sign, every additional hour the BRH spends is pure cost to them. They are economically motivated to be efficient, file cleanly, and avoid exigências.

The catch: flat-fee BRHs typically require a multi-year contract (so the firm can amortize Year 1 work) and exclude government fees, certified translations for regulatory authorities outside ANVISA, and importation handling.

This model is also rare. As of April 2026, Pure Global is the only major BRH service provider that publishes a complete flat-fee schedule on its website (pureglobal.com/services/pricing), which makes it the only published reference point for buyers comparing models.

Why this guide uses Pure Global as the worked example

We use Pure Global's published BRH rates throughout this article because they are the only flat-fee BRH rates in the public domain — anyone can verify them at pureglobal.com/services/pricing. This is not an endorsement and not every reader will choose Pure Global. The published rates simply let us do an apples-to-apples cash flow comparison that would otherwise require RFPs to multiple firms operating under NDA. Industry ranges shown for hourly and front-loaded models are based on typical RFP responses, published consulting hourly rate benchmarks, and procurement data collected by MedDeviceGuide.

Recommended Reading

Brazil Medical Device Market Deep Dive: ANVISA Registration Trends, Data Analysis & Market Access Strategy (2024-2025)

ANVISA Regulatory2026-04-13 · 39 min read

Pure Global Brazil BRH Pricing (Published, April 2026)

Class I and Class II — Notification Pathway

Number of Notifications	Annual Flat Fee (USD)
1	$2,000
2	$3,000
3	$4,000
4	$5,000
5	$6,000
6	$6,500
7	$7,000
8	$7,500
9	$8,000
10	$8,500
11+	Custom quote

Included in the annual fee:

• Preparation and submission of the ANVISA notification
• All required Portuguese translations
• All Letters of Importation (Cartas de Importação) — unlimited
• All modifications (changes to device specs, labeling, intended use, manufacturer)
• All correspondence with ANVISA on the registered devices
• UDI submissions (SIUD database under IN 290/2026)
• Coordination with INMETRO and ANATEL certification bodies (where applicable)

Not included: ANVISA government fees, INMETRO/ANATEL test laboratory fees, certified translations required for non-ANVISA authorities, importation handling by the BRH itself.

Class III and Class IV — Registration Pathway

Number of Registrations	Annual Flat Fee (USD)
1	$3,000
2	$4,500
3	$6,000
4	$7,500
5	$9,000
6	$10,000
7	$11,000
8	$12,000
9	$13,000
10	$14,000
11+	Custom quote

Included in the annual fee (in addition to all Class I/II inclusions):

• BGMP certification filing with ANVISA
• Registration renewals (filed every 10 years per RDC 751/2022)
• Coordination with ANVISA on technical clarifications (exigências)

Not included: the BGMP government fee (BRL 72,805) or the BGMP audit travel costs paid directly to ANVISA inspectors; clinical evidence preparation; INMETRO/ANATEL test fees.

Contract Terms

• Standard contract: 3 years.
• Annual contract option: available, but the first-year fee is increased by 50%.
• Early termination: allowed at any time with a 50% payoff of the remaining contract value.
• Ad-hoc consulting (non-clients or out-of-scope work): $150/hour.
• Temporary Importation Letter: $300 (existing BRH clients), $500 (non-clients), or included for new BRH clients during onboarding.

(Source: pureglobal.com/services/pricing, captured April 2026. Price list version 1.0, last updated 2026-03-31.)

3-Year Cash Flow: Side-by-Side Comparison

The pricing model only matters because of cash timing. The following scenarios show the same scope of work — one device, BRH only, government fees excluded — under each of the three models. Numbers are illustrative and based on the ranges given above.

Scenario A: Single Class II Device, 3-Year Total

Cost Bucket	Hourly Billing	Registration + Annual	Flat Fee (Pure Global)
Year 1 setup + filing	$7,500 (50 hrs × $150)	$4,500 ($2,000 setup + $2,500 filing)	$2,000
Year 1 IULs / modifications	$1,500 (10 hrs)	$1,000 (2 mods × $500)	included
Year 1 total	$9,000	$5,500	$2,000
Year 2 maintenance	$3,000 (20 hrs)	$2,000 annual + $1,000 mods	$2,000
Year 3 maintenance	$3,000 (20 hrs)	$2,000 annual + $1,000 mods	$2,000
3-Year Total	$15,000	$11,500	$6,000
Year 1 share of 3-year spend	60%	48%	33%

The Year 1 burden under flat fee is $2,000 vs $9,000 under hourly — for the same regulatory output. That $7,000 of cash that does not leave the company in Year 1 is, for an early-stage MedTech, often the difference between launching in Brazil this fiscal year and deferring 18 months.

Scenario B: Single Class III Device, 3-Year Total

Cost Bucket	Hourly Billing	Registration + Annual	Flat Fee (Pure Global)
Year 1 setup + dossier filing	$20,000 (130 hrs × $155 blended)	$10,000 ($3,500 setup + $6,500 filing)	$3,000
Year 1 BGMP filing coordination	$2,500	$2,000	included
Year 1 modifications + IULs	$2,500	$1,500	included
Year 1 total	$25,000	$13,500	$3,000
Year 2 maintenance	$5,000 (32 hrs)	$4,000 annual + $1,500 mods	$3,000
Year 3 maintenance	$5,000 (32 hrs)	$4,000 annual + $1,500 mods	$3,000
3-Year Total	$35,000	$24,500	$9,000
Year 1 share of 3-year spend	71%	55%	33%

Under hourly, 71% of the 3-year BRH cost lands in Year 1 — the worst possible time for a Brazil entrant who has not yet earned Brazilian revenue. Flat fee distributes the same scope of work evenly, freeing roughly $22,000 of Year 1 working capital for testing, clinical evidence, INMETRO certification, or sales hires.

Scenario C: 5-Device Portfolio (3 Class II + 2 Class III)

Cost Bucket	Hourly Billing	Registration + Annual	Flat Fee (Pure Global)
Year 1 total	$50,000–$75,000	$30,000–$45,000	$4,000 (3 Class II) + $4,500 (2 Class III) = $8,500
Year 2	$15,000–$25,000	$12,000–$20,000	$8,500
Year 3	$15,000–$25,000	$12,000–$20,000	$8,500
3-Year Total	$80,000–$125,000	$54,000–$85,000	$25,500

For multi-device portfolios, the flat-fee tier discount (each additional device is incremental, not multiplicative) compounds the savings. A 5-device portfolio at Pure Global's published rates costs less than a single Class III device under hourly billing.

What "All-Inclusive" Actually Means: Scope Checklist

When BRH proposals all claim to "include everything," the differences are in the fine print. Use this checklist to compare proposals line by line.

Service Item	Hourly (typical)	Reg + Annual (typical)	Flat Fee — Pure Global
Initial notification/registration filing	hourly	one-time setup fee	included
Portuguese translation of submission documents	hourly	sometimes included, sometimes per-page	included
Letters of Importation (IUL / Carta de Importação)	hourly per letter	$50–$500 each	included, unlimited
Modifications (labeling, specs, manufacturer change)	hourly per modification	$500–$5,000 each	included, unlimited
ANVISA correspondence and exigência responses	hourly	hourly above contract scope	included
UDI database (SIUD) submissions	hourly	sometimes extra	included
BGMP filing coordination (Class III/IV)	hourly	$1,000–$2,000 extra	included
Registration renewal at Year 10 (Class III/IV)	hourly	$2,000–$6,000 extra	included
Distributor authorization letters	$100–$500 each	$100–$500 each	included or $300–$500 ad-hoc
Vigilance / adverse event reporting	hourly	hourly or per-event	hourly ad-hoc
Temporary Importation Letter	hourly	$300–$500 each	$300 (client) / $500 (non-client)
Coordination with INMETRO/ANATEL	hourly	sometimes included	included
Certified translations for non-ANVISA authorities	hourly	extra	not included
Importation handling and customs brokerage	not in BRH scope	not in BRH scope	not included

The scope items that quietly drive Year-2-and-beyond cost overruns under the hourly and reg-plus-annual models are: modifications, IUL letters, and exigência responses. Together they generally account for 40–70% of post-Year-1 BRH spend. Whether they are inside or outside the flat fee is the single biggest line in any side-by-side comparison.

Recommended Reading

Clinical Equivalence Assessment Under EU MDR: Technical, Biological, and Clinical Equivalence

Clinical Evidence EU MDR / IVDR2026-04-24 · 12 min read

What 2026 ANVISA Regulatory Churn Costs Under Each Pricing Model

Brazil's regulatory environment between 2022 and 2026 has been more active than at any time since RDC 185/2001. Each rule change forces existing registrations to file modifications, generate UDI submissions, repackage technical files, or update labeling. Under hourly billing or reg-plus-annual, every one of those filings is a billable event. Under flat fee, they are not. This is the line item that competitors do not bring up during the sales call, and it is where the case for flat fee gets quantitatively compelling.

Modification Volume from 2022–2026 ANVISA Rules

The table below shows the cumulative modification load that a typical device on the Brazilian market has had to absorb in the four years since RDC 751 took effect.

Regulation	Effective	Modification Type Triggered	Typical Modifications per Device
RDC 751/2022	March 2023	Re-classification under new rules, GSPR alignment, label updates	1–2 filings
RDC 830/2023	June 2024	IVD-specific re-classification and labeling	1–2 filings (IVDs)
RDC 848/2024	2025	Updated safety and performance requirements (replaces RDC 546/2021)	1 filing
RDC 884/2024 (UDI)	Phased	UDI/SIUD database submissions per phase	1–3 SIUD submissions
IN 290/2024 → 290/2026	June 2024 / 2026	AREE reliance pathway adoption + UDI deadline alignment	1–2 filings
Periodic labeling/IFU clarifications	Ongoing	Label, IFU, packaging text changes	1–2 per device per year

Aggregated, a typical Class II device sold in Brazil has filed 5–9 cumulative modifications since 2022. Class III/IV devices, with broader GSPR and UDI scope, are closer to 8–14 filings.

What That Modification Volume Costs You

Pricing Model	Per-Filing Cost	4-Year Cost (Class II, 5 filings)	4-Year Cost (Class III, 14 filings)
Hourly billing (3–8 hrs × $235 blended)	$700–$1,900	$3,500–$9,500	$9,800–$26,600
Reg fee + annual ($500–$5,000 each)	$500–$5,000	$2,500–$25,000	$7,000–$70,000
Pure Global flat fee	included	$0 incremental	$0 incremental

Under hourly or reg-plus-annual, regulatory churn becomes a hidden tax that scales with how active the regulator is — not with how active you are. ANVISA is currently one of the more active medical device regulators in the world. That is exactly the wrong environment in which to sign a 3-year hourly contract.

What ANVISA Has Queued for 2026–2028

The pipeline already in consultation or scheduled, each of which will trigger fresh filings:

• UDI Phase deadlines under RDC 884/2024: Class III/IV (September 2026), Class II (March 2028), Class I (March 2030). Each phase requires SIUD database submissions and labeling updates.
• AREE reliance pathway expansion under IN 290/2026: existing registrations using reference-market data may need to re-submit when foreign authorizations update.
• Continued RDC 848/2024 GSPR clarification ordinances — expected through 2027.
• SaMD AI/ML follow-on guidance under RDC 657/2022 — expected 2026–2027.

A reasonable 2026–2028 forecast for an existing Class III device on the market is 3–5 additional modifications. At hourly rates that is another $2,000–$10,000 per device. Under flat fee, $0.

For a portfolio holder with 5 Class III devices, the difference between "modifications included" and "modifications billable" over 2026–2028 is roughly $10,000–$50,000 in net Brazil P&L impact — money that ends up either in your operating budget or in your BRH's invoice. Same regulatory work, same outcome with ANVISA, just different invoice line.

When Flat Fee Wins, and When It Does Not

Flat fee is not universally the best choice. The decision framework:

Flat fee usually wins when:

• You expect to keep the device on the Brazilian market for ≥3 years.
• You have ≥2 devices in your Brazil portfolio (tier discounts compound).
• Your devices are commercially active — meaning ongoing IULs, modifications, distributor changes, and labeling updates.
• You are pre-revenue or capital-constrained in Year 1 and want to smooth cash outflow.
• You do not want to micromanage hourly billing or audit consultant invoices.

Hourly billing might still win when:

• You are doing a one-time discovery exercise (e.g., a regulatory feasibility assessment) and do not yet have a registration to maintain.
• You have a single Class I device that you expect to file once and never modify.
• You need ad-hoc strategic counsel (e.g., responding to a vigilance investigation) outside an existing BRH relationship.

Registration-fee-plus-annual is rarely the optimal choice on TCO grounds. It typically lands between hourly and flat fee on cost while preserving the cash flow problem of Year 1 front-loading.

Government Fees: A Quick Reference

BRH service fees are excluded from ANVISA government fees in every model. For completeness, the official 2026 government fees are:

Filing	Government Fee (BRL)	Approximate USD
Class I/II Notification	BRL 1,405.73	~$265
Class III/IV Registration (small/medium family)	BRL 8,509.92	~$1,606
Class III/IV Registration (large family — installed equipment)	BRL 19,856.48	~$3,747
BGMP Certification (international manufacturers)	BRL 72,804.90	~$13,737
BGMP Certification (MERCOSUL-based manufacturers)	BRL 10,637.40	~$2,007
Procedural Review Fee	BRL 1,405.73	~$265

For a complete breakdown including INMETRO, ANATEL, BGMP audit travel, and clinical evidence costs, see Brazil ANVISA Medical Device Cost Breakdown 2026.

Recommended Reading

Colombia Medical Device Registration Cost 2026: INVIMA Representative Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison

Regulatory Reimbursement & Market Access2026-04-24 · 42 min read

8 Questions to Ask Any BRH Before You Sign

This checklist works regardless of which BRH you are evaluating. Demand explicit, written answers before signing — not verbal assurances during the sales call.

1. Is the fee fixed for the contract term, or subject to annual escalation? If escalation: capped at what (CPI? IPCA? uncapped?).
2. How many letters of importation are included per year? "Unlimited" should be in writing. "Reasonable use" is a red flag.
3. How many modifications are included per year? Is the cap per device or per portfolio? What counts as a modification (labeling? IFU? manufacturer change? class change?).
4. What is the per-hour rate for out-of-scope work? Some firms advertise low base fees and charge $400+/hour for anything outside scope.
5. Who pays if ANVISA issues an exigência? Under hourly, you do. Under flat fee, the BRH should. Confirm in writing.
6. What are the termination terms? Pure Global publishes 50% payoff of remaining contract value. Many competitors require full payoff or 12-month notice. This matters more than the headline price.
7. Does the BRH hold the registration or does the distributor? If a distributor holds your registration and you switch distributors later, you typically need to re-file the entire registration. Always insist on a registration held by an independent BRH, not by your importer.
8. Will the BRH provide a transfer letter at no cost if you decide to leave? Some firms hold the registration hostage. Get the transfer-out commitment in writing before signing.

If a BRH refuses to answer any of these in writing, that is the answer to the question.

BRH Switching Playbook: How to Leave Without Getting Trapped

The single most expensive mistake in BRH selection is signing a contract you cannot exit affordably. Many foreign manufacturers discover, 18 months in, that their BRH is mediocre but switching costs more than staying. This section is the operational playbook competitors avoid publishing.

The ANVISA Holder Change Procedure (Transferência de Titularidade)

ANVISA permits transfer of holder for both notifications and registrations. The mechanic:

Step	Who Performs	Typical Duration	Notes
1. Manufacturer issues new Power of Attorney to incoming BRH	Manufacturer + new BRH	1–2 weeks	Apostilled (Hague Convention) or consularized
2. Outgoing BRH issues transfer letter	Outgoing BRH	0 days to 6 months	This is the choke point. Some firms drag this through the full notice period.
3. New BRH files Transferência de Titularidade	New BRH	30–60 days ANVISA processing	Class I/II faster
4. Outgoing BRH cancels its association	Outgoing BRH	30 days	Mostly mechanical
5. Updated certificate issued by ANVISA	ANVISA	30–90 days	Public via ANVISA Consultas
Total realistic timeline		60–180 days (Class I/II), 90–240 days (Class III/IV)	Faster if outgoing BRH cooperates

The bottleneck is almost always step 2. ANVISA cannot process a holder change without a transfer letter from the outgoing holder. A BRH that wants to retain you can effectively delay your departure by stalling on this single document.

Contract Termination Clauses: How They Actually Compare

The termination clause buried in your BRH agreement is often more economically consequential than the headline annual fee. Common terms in the market:

Termination Term	Typical Industry Practice	Pure Global Published Term
Notice period required	6–12 months	None — termination effective on contract anniversary
Payoff of remaining contract value on early exit	100% of remaining contract	50% payoff of remaining contract
Transfer letter delivery commitment	Within "reasonable time" (undefined)	Standard contract term
Separate "transfer fee" charged at exit	$1,500–$5,000 typical	None
Right to withhold registration certificate	Sometimes asserted	Explicitly waived in published terms

If you sign a typical industry BRH contract today that requires 12 months notice plus 100% payoff of remaining term, the effective cost of switching mid-contract on a $5,000/year deal is $5,000 (notice fees) + $10,000 (remaining 2-year payoff) + $3,000 (transfer fee) = $18,000 before you pay the new BRH a cent. That is more than 3 years of flat-fee under Pure Global's published rate for a single Class II device.

The Distributor-as-BRH Lock-In Trap

The most common trap for first-time Brazil entrants: letting the in-country distributor double as the BRH. Up front this looks efficient — one relationship, no separate retainer, the distributor often offers BRH services "for free" as part of the commercial deal. The economic reality is harsher.

If your distributor holds the registration:

• Switching distributors often requires re-registration, not just a holder transfer. Some registrations are tied so closely to the importer's CNPJ that ANVISA effectively requires a fresh filing if the commercial relationship changes. That costs $3,000–$10,000 and takes 6–12 months for Class III/IV — during which you cannot sell.
• The distributor has implicit veto power over your Brazilian commercial strategy. Want to add a second importer? They can refuse to issue parallel IULs. Want to renegotiate margins? They can drag transfer letters. Want to terminate for non-performance? You face re-registration delay risk.
• The "free BRH" is always priced into the distributor margin. Industry practice is 5–15% commercial markup that effectively covers the BRH function plus profit. For a $5M/year Brazil business, that is $250,000–$750,000/year in implicit BRH cost — paid to the same firm whose interests can diverge from yours.

The right structure: an independent BRH holds the registration, and one or more distributors are authorized importers under that registration. The independent BRH issues IULs to whichever distributor is shipping. Switching distributors becomes a commercial decision, not a regulatory one. You pay $2,000–$8,000/year for the BRH and recapture the 5–15% distributor margin you would otherwise have paid for it.

Clean Switching: 7-Step Sequencing

1. Sign the new BRH first, with the contract conditional on successful transfer of named registrations.
2. Generate fresh PoAs in parallel. Apostille or consularize before notifying the outgoing BRH.
3. Time the notice letter to land 30 days before the contract anniversary to minimize early-termination cost.
4. Cite specific contract clauses in your termination letter (the transfer letter delivery commitment, in particular). Many BRHs respond to legal pressure but not commercial requests.
5. File the Transferência de Titularidade the day you receive the transfer letter — do not wait for batch processing.
6. Hold IUL coverage continuous — the incoming BRH should issue all imports starting from ANVISA approval date, not the contract effective date. Gaps mean stuck shipments.
7. Confirm SIUD/UDI account credentials transfer — under RDC 884/2024 the SIUD account is tied to the holder; a switch requires new credentials, not just access updates.

A well-executed switch costs $2,000–$5,000 in legal/operational time and 60–120 days of effort. A poorly executed switch can cost a year of market access. The contract termination clause is the upstream variable that determines which one you get — and it is therefore the clause you should negotiate hardest before signing.

Named Provider RFP Comparison: Pure Global vs Typical Competitor Quotes

For this article we modeled the same scope of work — a single Class II medical device entering Brazil, 3-year holder relationship, all standard inclusions — under three pricing structures: Pure Global (with rates verified on its public pricing page), and two composite industry quotes (one hourly-billing model, one registration-fee-plus-annual model) built from typical RFP responses from BRH service providers in the Brazilian market.

The comparison uses the midpoint of each composite range for the hourly and reg-plus-annual columns. The Pure Global column uses the published rate. Competitor firms are not named individually because, unlike Pure Global, they do not publish prices and we cannot publish their proposal data without consent.

Same Scope, Three Models, 3-Year Total

Scope baseline: 1 Class II medical device, ANVISA notification under RDC 751/2022, foreign manufacturer, 3-year contract, average import volume (6 IULs/year), 1–2 modifications per year (consistent with 2026 ANVISA churn).

Line Item	Pure Global (Flat Fee)	Composite Hourly Quote	Composite Reg+Annual Quote
Year 1 — initial filing & setup	$2,000 (annual fee)	$7,500 (50 hrs × $150 blended)	$5,500 ($2,000 setup + $3,500 filing)
Year 1 — translation	included	$1,200 (8 hrs T3)	$800–$1,500 per-page
Year 1 — IUL letters (6 per year)	included, unlimited	$900 (6 hrs T3)	$300–$1,800 (per-letter fees)
Year 1 — UDI/SIUD submission	included	$470 (2 hrs T2)	$500–$1,000 separately quoted
Year 1 — 1 modification	included	$470 (2 hrs T2)	$500–$2,000
Year 1 total	$2,000	$10,540	$7,600–$11,800
Year 2 — annual maintenance	$2,000	$3,000 (20 hrs blended)	$2,000–$3,000 base
Year 2 — 2 modifications + 6 IULs	included	$1,820	$1,300–$5,800
Year 3 — annual maintenance	$2,000	$3,000	$2,000–$3,000
Year 3 — 2 modifications + 6 IULs	included	$1,820	$1,300–$5,800
3-Year Total	$6,000	$20,180	$14,200–$29,400

(Pure Global rates verified at pureglobal.com/services/pricing. Composite ranges drawn from typical Brazilian BRH RFP responses observed by MedDeviceGuide; individual firm numbers vary.)

Key Takeaways from the Comparison

• Pure Global at the published rate is 3.4x cheaper than the composite hourly quote over 3 years, and 2.4x to 4.9x cheaper than the composite reg+annual quote.
• The cost gap widens further in Years 2 and 3 if the device generates above-average modifications — which, given 2026 ANVISA churn (UDI deadlines, RDC 848 GSPR clarifications, IN 290 reliance pathway), is the realistic case for almost every device.
• The reg-plus-annual model has the widest bracket because providers vary enormously on whether modifications and IULs are inside the annual fee or billed separately. Read every "included" claim line by line.
• The flat-fee model is insulated from invoice variance. The only variable you control is whether you signed Class I/II or Class III/IV pricing — everything else is a fixed cost.

Why Composite Instead of Named Competitors

Three reasons. First, no other major BRH provider publishes its prices, so naming Firm X with a specific number invites disputes we cannot resolve without violating NDAs on proposals we have seen. Second, every firm's quote varies by negotiation, scope inclusion, and volume — single-firm naming gives a misleadingly precise picture. Third, the point of this analysis is the structural difference between pricing models, not which specific competitor is best.

If you want firm-specific pricing for a named competitor, the only way to get it is to issue your own RFP. The next section gives you a template designed to force apples-to-apples comparisons.

Recommended Reading

Costa Rica Medical Device Registration Guide: Ministry of Health Process, Spanish Documentation, and LATAM Strategy

Regulatory Commercialization2026-04-24 · 13 min read

BRH RFP Template Copy and Paste

Most BRH RFPs come back from competing firms in three different formats with three different scope inclusion lists, making side-by-side comparison nearly impossible. Use the template below to force every responding firm into the same structure. Copy, paste, fill in the blanks, send.

---

Subject: Request for Proposal — Brazilian Registration Holder (BRH) Services for [Manufacturer Name]

Dear [Provider],

[Manufacturer Name] is evaluating Brazilian Registration Holder service providers for our medical device portfolio entering or maintaining presence in the Brazilian market. We are issuing this RFP to [N] firms and request a written proposal by [date].

Portfolio Scope

#	Device Name	ANVISA Class	Pathway (Notification / Registration)	Currently Registered?	Anticipated Modifications/Year
1	[Device A]	[I / II / III / IV]	[Notification / Registration]	[Yes / No]	[N]
2	[Device B]

Contract Term: We anticipate a [3-year / 5-year] BRH relationship.

Required Pricing Format

Please provide pricing in the following table for each year of the contract term. Indicate explicitly whether each line item is included in the base fee or billed separately, and if separately, on what unit basis.

Service Item	Year 1 Cost	Year 2 Cost	Year 3 Cost	Inclusion (Y/N)	Per-Unit Rate if Separate
Initial notification/registration filing per device
Portuguese translation of submission documents
Letters of Importation (IUL) — please state limit
Modifications — please state limit
ANVISA exigência response
UDI/SIUD database submissions
BGMP filing coordination (Class III/IV only)
Registration renewal at Year 10 (Class III/IV only)
Distributor authorization letters
Vigilance / adverse event reporting
Coordination with INMETRO and ANATEL
Out-of-scope hourly rate (T1 / T2 / T3)

Required Disclosures

1. Annual fee escalation clause — fixed, CPI-linked, IPCA-linked, or uncapped?
2. Notice period required for non-renewal at end of term.
3. Early termination payoff — what percentage of remaining contract value?
4. Transfer letter delivery commitment in days from termination notice.
5. Any separate "transfer fee" charged at exit — yes/no, amount.
6. Government fees — confirm passed through at cost without markup.
7. Whether you hold the registration in trust or as an agent — and whether you assert any right to withhold the registration certificate during a dispute.

Evaluation Criteria

We will evaluate proposals on (in order): (1) total 3-year cost at our forecast scope, (2) inclusion completeness — fewer separately-billed line items is better, (3) termination clause flexibility, (4) responsiveness during this RFP, (5) ANVISA filing track record (please attach 2–3 references).

Please respond by [date] to [contact email].

Best regards,

[Your Name]

[Your Title], [Manufacturer Name]

---

This template forces every BRH to price the same scope. The line items where firms diverge most — modifications, IULs, exigência responses, and termination clauses — are exactly the items the template makes them disclose explicitly. After three to five proposals come back in this format, the right answer for your portfolio is usually obvious within an hour of comparing.

Frequently Asked Questions

Is a Brazilian Registration Holder the same as a distributor?

No. A BRH holds the ANVISA registration on behalf of the foreign manufacturer and acts as ANVISA's regulatory point of contact. A distributor imports and sells the device commercially. The same entity can play both roles, but combining them is generally a bad idea — if the commercial relationship sours, the distributor controls the registration and you cannot leave without re-registering the device.

Can I be my own BRH?

Only if you have a Brazilian legal entity with the appropriate authorizations (Autorização de Funcionamento de Empresa from ANVISA). Most foreign manufacturers find the cost of standing up and maintaining a Brazilian regulatory entity exceeds the cost of an independent BRH for the first 5–10 devices.

How long does a BRH transition take if I want to switch?

Typically 60–120 days for Class I/II notifications and 90–180 days for Class III/IV registrations. The current BRH must issue a transfer letter; ANVISA must process the change of holder; the new BRH must update the file. Pure Global's standard 50% remaining-contract-value early-termination clause is among the more buyer-friendly in the industry — many BRHs require full remaining contract payoff plus 6–12 months of notice.

Does the BRH pay government fees on my behalf?

Yes — the BRH submits the GRU (Guia de Recolhimento da União) on your behalf, but the underlying ANVISA fee is reimbursed by the manufacturer at cost. Reputable BRHs do not mark up government fees. If a BRH refuses to pass through ANVISA fees at cost, walk.

What happens if my device gets an ANVISA exigência (technical clarification request)?

The exigência response window is typically 60–120 days. Under hourly billing, every hour spent on the response is billed at the consultant's rate. Under registration-plus-annual, exigência responses are sometimes inside scope and sometimes billed separately. Under Pure Global's flat-fee model, exigência responses are inside the annual fee and not billed extra. Confirm this point in writing — it can be the single largest year-2 expense for borderline-classified Class III devices.

Can I negotiate the flat-fee price?

Pure Global publishes the price, which means the published rate is the rate. The negotiable variables are typically scope (number of devices, contract length) rather than the per-device fee. For 11+ device portfolios, custom pricing applies and is generally negotiable on volume terms.

What about Class IV devices that require clinical investigations?

The BRH fee covers the registration filing and ANVISA correspondence. It does not cover the clinical investigation itself, which is regulated under RDC 10/2015 and 837/2023 and typically costs $200,000–$2M+ depending on study design. Plan and budget the clinical study independently of the BRH service fee.

How does BRH cost compare to other major markets?

For comparable in-country representation, Brazil's BRH cost ($2,000–$8,000/year flat fee) sits between Mexico's COFEPRIS Authorized Representative ($2,000–$5,000/year) and Japan's DMAH ($15,000–$50,000/year). See Medical Device Registration Cost by Country: 2026 Global Comparison for the full benchmark.

Bottom Line

Brazil's government fees are not where Brazil registration budgets get blown up. The line item that wrecks budgets is the BRH service fee — specifically the cash flow shape of when those fees hit. Hourly billing front-loads 60–75% of 3-year cost into Year 1, when there is no Brazilian revenue. Registration-fee-plus-annual front-loads 50–55%. Flat all-inclusive billing flattens it to roughly 33% per year, which is the only pricing model that aligns with how MedTech revenue actually scales in a new market.

The numbers in this guide are 2026 benchmarks. The pricing model questions are timeless. Ask them before you sign.

Related Guides

• Brazil ANVISA Medical Device Registration: The Complete Guide
• Brazil ANVISA Medical Device Cost Breakdown 2026
• Brazil ANVISA Registration Data Analysis 2024–2025
• Brazil SUS Medical Device Procurement Guide
• Medical Device Registration Cost by Country: 2026 Global Comparison
• Medical Device Regulatory Consulting Hourly Rates by Region