ANVISA current fee schedule, reviewed for 2026, in BRL.
12 fee lines100% exact amountscurrency BRLFX rates 2026-09-07reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Class I/II notification (fato gerador 752) Exact payable amount depends on the ANVISA-recognized company-size group. | BRL 175.72–3,514.32 | $34.31–$686 | Per notification | Verified |
| Class III/IV registration — medium/small device (731) Single device; range is microenterprise through Group I large enterprise. | BRL 780.96–15,619.20 | $152–$3,049 | Per registration | Verified |
| Class III/IV registration — medium/small family (733) Range is microenterprise through Group I large enterprise. | BRL 1,063.74–21,274.80 | $208–$4,154 | Per family registration | Verified |
| Class III/IV registration — large equipment (730) Large diagnostic or therapeutic equipment; range depends on company size. | BRL 1,952.40–39,048.00 | $381–$7,623 | Per registration | Verified |
| Class III/IV registration — large-equipment family (732) Range is microenterprise through Group I large enterprise. | BRL 2,482.06–49,641.20 | $485–$9,692 | Per family registration | Verified |
| Registration renewal — medium/small device (735) The Annex already includes the renewal discount and company-size reductions. | BRL 702.86–14,057.28 | $137–$2,744 | Per renewal | Verified |
| Registration renewal — medium/small family (736) | BRL 957.37–19,147.32 | $187–$3,738 | Per family renewal | Verified |
| Registration renewal — large equipment (734) | BRL 1,757.16–35,143.20 | $343–$6,861 | Per renewal | Verified |
| Registration renewal — large-equipment family (737) | BRL 2,233.85–44,677.08 | $436–$8,722 | Per family renewal | Verified |
| Post-registration change or inclusion (738) Labeling/instructions-only changes under fact generator 742 are exempt. | BRL 175.72–3,514.32 | $34.31–$686 | Per petition | Verified |
| GMP certification — Brazil or Mercosur site (726) Company-size discounts apply. | BRL 1,329.68–26,593.50 | $260–$5,192 | Per site and production line | Verified |
| GMP certification — site outside Mercosur (727) RDC 857/2024 excludes non-Mercosur GMP certification from company-size discounts. | BRL 72,804.90 | $14,214 | Per site and production line | Verified |
Government fees only — service and testing costs are separate- RDC 857/2024 Annex I publishes six exact TFVS amounts for each applicable fact generator: Group I/II large, Group III/IV medium, small, and microenterprise.
- The displayed range is the official microenterprise-to-Group-I range, not an estimate. Without accepted proof of size, ANVISA assigns Group I and charges the maximum.
- Registration and GMP certification are separate charges; foreign-site GMP is manufacturer/site-level rather than per device.
- Statutory basis: Lei 9.782/1999 Anexo II (MP 2.190-34/2001) items 7.1-7.7 — AFE fabricante R$ 10,000 / distribuidora-importadora R$ 8,000 / varejista R$ 5,000; CBPF and CBPD/A R$ 15,000/ano; registro grande porte R$ 20,000 per 5 years and outros R$ 8,000; família grande porte R$ 28,000 and outros R$ 12,000; alteração R$ 1,800; certificado de exportação exempt; statutory porte reductions of 15/30/60/90/95% by company size. ANVISA’s TFVS page states collection follows RDC 222/2006 (amended by RDC 76/2008) Anexo I, so the Anexo II figures are the statutory basis rather than necessarily the currently collected values. GRU must be paid before petitioning and is valid 30 days.
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Exact amounts verified against the ANVISA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:brazil:notification-class-i-ii