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Brazil Medical Device Registration Fees
ANVISA government fees for 2025
BRL 1,406
Low Risk Min
BRL 72,805
High Risk Max
ANVISA
Authority
2025-09-03
Last Updated
Brazil (ANVISA) Fee Overview
Brazil (ANVISA) requires per-product registration fees ranging from BRL 1,406 (~$280) for Class I/II to BRL 8,510-19,856 (~$1,700-$4,000) for Class III/IV. Additionally, Class III/IV devices require B-GMP certification costing BRL 72,805 (~$14,500) for international manufacturers. B-GMP is a one-time manufacturer-level fee, not per-product.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Notification Fee (Class I/II) | BRL 1,406 | Per product |
Registration Fee - Family (Class III/IV) | BRL 8,510 | Per product |
Registration Fee - Large Family (Class III/IV) | BRL 19,856 | Per product |
B-GMP Certification - International (Class III/IV) Required for Class III/IV | BRL 72,805 | One-time per manufacturer |
B-GMP Certification - MERCOSUL (Class III/IV) For MERCOSUL countries only | BRL 10,637 | One-time per manufacturer |
Procedural Review Fee | BRL 1,406 | If applicable |
Key Facts About ANVISA Fees
- 1Class I/II notification: BRL 1,406 per product
- 2Class III/IV registration: BRL 8,510-19,856 per product
- 3B-GMP international: BRL 72,805 (one-time per manufacturer)
- 4B-GMP MERCOSUL: BRL 10,637 (reduced rate)
- 5Registration renewal: 50% of original fee
Important Notes
- •Class I/II: Notification process
- •Class III/IV: Registration + B-GMP certification required
- •B-GMP is manufacturer-level, not product-level
Tips for Brazil Registration
- 1Get B-GMP certification before submitting product registrations
- 2MERCOSUL manufacturers get reduced B-GMP fees
- 3Class I/II (notification) is faster and cheaper than registration
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2025-09-03. Always verify current fees with ANVISA.