How to quote Brazilian ANVISA official fees correctly

1. Key takeaways

There is no fixed price list for Brazilian official fees: the amount of the fee for health surveillance of goods (TFVS) is determined by the procedure code of the application and by company size, with size divided into 6 tiers (Grupo I–IV, EPP and ME) and reductions applied at the prescribed ratios. GRZAN therefore provides only the pricing mechanism and the official lookup entry, lists no specific figures, and never writes any circulating number into a quotation. That discipline protects both sides of the engagement from a promise nobody can control. In other words, the same procedure can cost different amounts for different companies, and the only way to know the current value is to look it up at the moment of filing.

2. Legal basis

• National Health Surveillance System and the Creation of ANVISA — Lei No. 9.782/1999, published on January 26, 1999; Article 23 (creation of the fee for health surveillance of goods, the fee schedule and reductions by company size)
• Procedures for charging the fee for health surveillance of goods — RDC No. 857/2024, published on May 9, 2024, in force as of June 3, 2024; consolidation of previous fee rules, review of the company’s economic capacity, and rules on payment slips
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, of August 14, 2013; Article 2 (companies must be authorized by ANVISA)
• The single authoritative official lookup: ANVISA Consulta de Assuntos (consultas.anvisa.gov.br)

3. Expert insights

The GRZAN view: the specific amounts circulating online mostly come from service-provider quotation documents or self-media compilations; they are not the official fee schedule, and the currency conversion changes with every exchange-rate move. Writing such figures into a contract plants a commitment that can drift at any moment, and once the official values change, responsibility for the difference becomes impossible to settle cleanly between the parties. GRZAN’s position is not that numbers should never be discussed; it is that a number quoted without a date and a source will eventually be wrong, and no contract should depend on it.

The second point: company size is almost the only controllable variable. The amount is determined by the procedure code multiplied by company size, with reductions at the prescribed ratios; where a company has not first proven its size, the highest tier is charged in full. Preparing the size evidence is therefore itself a money-saving action, and submitting it after payment generally does not operate retroactively or produce a refund of the difference [practical estimate, subject to what ANVISA publishes]. The tier attaches to the Brazilian entity making the filing, so the evidence should be organized early in the project rather than assembled while a payment slip is already due.

Third, the same company pays differently across procedures. Registration, amendment, import and good manufacturing practice certificates each have their own procedure codes, and no single query can be extrapolated into the whole budget. GRZAN’s practice is to list the complete set of procedure codes first and then look up each item, because the total is not intuitive and the omissions are rarely random. The itemized approach also produces a paper trail showing that the budget was built from the official mechanism rather than from habit.

The fourth point concerns communication. Clients asking for a quotation are behaving entirely reasonably, and the correct answer is a quotation that lists the official fees as a separate line, noting that the values follow the official lookup current at filing, with any difference refunded or surcharged. That satisfies the client’s demand for transparency without hard-coding a variable nobody controls into a binding document.

The fifth point concerns budget management. The import stage also carries fees charged per procedure, and a single shipment may trigger several of them. GRZAN recommends listing every potentially triggered procedure before the first import and querying each one, so the budget is not estimated on a single procedure and then found to be far off when the actual payments arrive.

4. Practical recommendations

GRZAN recommends splitting the budget process into three steps: first, lock the list of procedure codes involved in the current filing; second, confirm the Brazilian entity’s company size tier and assemble the supporting evidence; third, in the month of filing, query the current values through Consulta de Assuntos and generate the payment slips. The three steps should end in a one-page budget table listing the procedure codes, the size tier and the query date, which then serves as the basis for internal approval. Where a filing spans several procedures, generating all the payment slips in the same session keeps the query dates consistent and simplifies the later audit trail.

In external quotations, list official fees and service fees separately, noting that official fees follow the official lookup at the time of filing. Size evidence should be prepared early and completed before the payment action, not submitted afterwards. Where a client insists on a definite number, state in writing that the figure is an estimate and not a quotation, and keep the correspondence record.

In addition, keep a screenshot and the query date for every lookup, retained for no less than three years after the end of the project, so that later audits and disputes have primary evidence. When the official pages change, those screenshots are the most direct way to show a client where a difference came from, and they frequently settle in minutes a question that would otherwise take weeks of correspondence. Retention also covers the payment slips themselves, since the amount actually charged is the final evidence of what was due at that moment.

5. Verification checklist

• □ Has the complete list of procedure codes for this filing been drawn up
• □ Has the Brazilian entity’s company size tier been confirmed with evidence prepared
• □ Was the size evidence submitted before payment
• □ Have the amounts been queried on consultas.anvisa.gov.br with screenshots retained
• □ Does the contract list official fees and service fees separately, subject to the current official values

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers entering the Brazilian market across the full holder and import chain: holder-structure design, AFE and operating authorization planning, importer qualification, vigilance readiness and official fee budgeting. For tailored support on Brazilian license holders, import qualifications and fee budgets, contact info@grzanglobal.com.