Brazil · Brazilian Health Regulatory Agency · New drugs
Review target
365 days
regulation
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
R$72,805
Fee table in force when checked (2026-10-03)
Anvisa certifies each manufacturing site, in Brazil or abroad. Medicine and higher risk device registrations are not granted until the certificate is published. Certificates last 2 years, or 4 years for device makers certified through the Medical Device Single Audit Program (MDSAP). Anvisa can rely on inspections of other regulators and recognized auditing bodies. Every manufacturing site of a medicine, biologic, vaccine or class III or IV device or IVD filed for registration in Brazil.
The official review target is 365 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The gmp certification, medicine site outside brazil and mercosur, per production line is R$72,805 for Fee table in force when checked (2026-10-03). A reduced fee of R$72,805 applies in some cases (Same amount for all company sizes).
1. Certification petition and fee; 2. Inspection or reliance on other inspections (365 days); 3. Certificate decision.
Outcome: GMP certificate published in the Official Gazette. Valid for 2 years.
Legal basis: Lei 6.360/1976 (Art. 18); Anvisa RDC 497/2021; Anvisa RDC 743/2022
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 365 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Target for medicine and standard device certifications. MDSAP-based device certifications have a 180-day target. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| GMP certification, medicine site outside Brazil and Mercosur, per production lineInspection · Fee table in force when checked (2026-10-03) · Same amount for all company sizes. | R$72,805reduced R$72,805 |
| GMP certification, device site outside Brazil and Mercosur, per production lineInspection · Fee table in force when checked (2026-10-03) · Same amount for all company sizes. | R$72,805reduced R$72,805 |
| GMP certification, medicine site in Brazil or Mercosur, per production lineInspection · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,464.30. | R$29,286reduced R$2,929 |
Other routes in Brazil: Registration of a new medicine, Registration of an innovative medicine, Registration of a generic medicine, Registration of a similar medicine, Non-prescription status (MIP) for a registered medicine, Registration of a new biological product (individual development route), Biosimilar registration (comparability route), Priority review of a registration petition, Special procedure for new medicines for rare diseases, Registration under a commitment term, Optimized analysis using an equivalent foreign authority, Notification of a class I or II medical device, Registration of a class III or IV medical device, Optimized analysis for class III and IV devices approved abroad, Notification of a class I or II in vitro diagnostic device. See all routes on the Brazil page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.