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ANVISA fees are part of several regulatory procedures required for companies and products subject to Brazilian health surveillance regulations. These include applications for the Company Operating Authorization (AFE), product registration or notification, regulatory amendments, and Good Practices certifications.
These amounts correspond to the Health Surveillance Inspection Fee (TFVS) and vary according to the requested service, the petition subject code, and the company's registered economic classification. The fee is generally generated during the application process through the Federal Payment Slip (Guia de Recolhimento da União – GRU).
On this page, you will find a table with the main ANVISA fees according to company size, covering micro, small, medium, and large companies. This information helps businesses plan the costs involved in procedures such as obtaining or amending an AFE, product regularization, and Good Practices certification.
It is important to ensure that your company's economic classification is properly documented and updated in ANVISA's records before issuing the fee. Companies that do not provide proof of a different classification are initially placed in Group I – Large, which may result in the full fee being charged. Updating the registration afterward does not guarantee reimbursement of any difference already paid.
The fees presented should be used as a reference for regulatory planning. Before submitting an application, it is recommended to confirm the applicable petition subject code, the company's classification, and the current fee schedule to avoid incorrect payments, delays, or regulatory requirements during the process.
| Micro Enterprise | Small Enterprise | Medium Group IV | Medium Group III | Large Group II | Large Group I | |
| OPERATING AUTHORIZATION - AFE | ||||||
| AFE - Distributor | R$ 709,16 | R$ 1.418,32 | R$ 5.673,28 | R$ 9.928,24 | R$ 12.055,72 | R$ 14.183,20 |
| AFE - Importer | R$ 709,16 | R$ 1.418,32 | R$ 5.673,28 | R$ 9.928,24 | R$ 12.055,72 | R$ 14.183,20 |
| AFE - Exporter | R$ 709,16 | R$ 1.418,32 | R$ 5.673,28 | R$ 9.928,24 | R$ 12.055,72 | R$ 14.183,20 |
| AFE - Manufacturer | R$ 976,20 | R$ 1.952,40 | R$ 7.809,60 | R$ 13.666,80 | R$ 16.595,40 | R$ 19.524,00 |
| AFE - Carrier | R$ 709,16 | R$ 1.418,32 | R$ 5.673,28 | R$ 9.928,24 | R$ 12.055,72 | R$ 14.183,20 |
| AFE Amendment (addition of activity) |
R$ 390,48 | R$ 780,96 | R$ 3.123,84 | R$ 5.466,72 | R$ 6.638,16 | R$ 7.809,60 |
| AFE Amendment (change of Technical/Legal Responsible Person) |
Exempt | Exempt | Exempt | Exempt | Exempt | Exempt |
| PRODUCT REGISTRATION AND NOTIFICATION | Micro Enterprise | Small Enterprise | Medium Group IV | Medium Group III | Large Group II | Large Group I |
| Registration of a Product [Risk Class III and IV] |
R$ 780,96 | R$ 1.561,92 | R$ 6.247,68 | R$ 10.933,44 | R$ 13.276,32 | R$ 15.619,20 |
| Registration of a Family of Similar Products [Risk Class III and IV] |
R$ 1.063,74 | R$ 2.127,48 | R$ 8.509,92 | R$ 14.892,36 | R$ 18.083,58 | R$ 21.274,80 |
| Notification of a Product or a Family of Similar Products [Risk Class I and II] |
R$ 175,72 | R$ 351,43 | R$ 1.405,73 | R$ 2.460,02 | R$ 2.987,17 | R$ 3.514,32 |
| Registration Amendment or Model Addition [Risk Class III and IV] |
R$ 175,72 | R$ 351,43 | R$ 1.405,73 | R$ 2.460,02 | R$ 2.987,17 | R$ 3.514,32 |
| Notification Amendment [Risk Class I and II] |
Exempt | Exempt | Exempt | Exempt | Exempt | Exempt |
| GOOD PRACTICES CERTIFICATION | Micro Enterprise | Small Enterprise | Medium Group IV | Medium Group III | Large Group II | Large Group I |
| Good Manufacturing Practices (GMP) Certification in Brazil and Mercosur | R$ 2.659,35 | R$ 2.659,35 | R$ 10.637,40 | R$ 18.615,45 | R$ 22.604,48 | R$ 26.593,50 |
| Good Distribution and Storage Practices (GDSP) Certification per Establishment in Brazil and Mercosur | R$ 1.329,68 | R$ 2.659,35 | R$ 10.637,40 | R$ 18.615,45 | R$ 22.604,48 | R$ 26.593,50 |
| Good Manufacturing Practices (GMP) Certification per Establishment in Other Countries | R$ 72.804,90 | R$ 72.804,90 | R$ 72.804,90 | R$ 72.804,90 | R$ 72.804,90 | R$ 72.804,90 |
RAGB supports companies throughout every stage of ANVISA regulatory procedures, from obtaining and amending an AFE to product registration, notifications, and certifications. With specialized regulatory support, your company reduces risks and completes each process with greater confidence.
Contact us using the form below and find out how we can help.