Brazil · Brazilian Health Regulatory Agency · Diagnostics (IVD)
Review target
30 days
regulation
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
R$3,514
Fee table in force when checked (2026-10-03)
In vitro diagnostic devices in classes I and II are notified. The agency processes a notification within 30 days. Class II notifications include a technical dossier; for class I the dossier stays with the company. IVDs, including instruments, that fall in class I or II under the IVD classification rules.
The official review target is 30 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The fee for exemption from registration (notification), health products is R$3,514 for Fee table in force when checked (2026-10-03). A reduced fee of R$351 applies in some cases (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 175.72).
1. File notification and pay fee; 2. Processing (30 days); 3. Publication.
Outcome: Notification published; the product can then be sold.
Legal basis: Lei 6.360/1976; Anvisa RDC 830/2023
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 30 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Official processing time. | 30 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Fee for exemption from registration (notification), health productsProduct · 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 175.72. | R$3,514reduced R$351 |
Other routes in Brazil: Good manufacturing practice certification (CBPF), Optimized analysis for class III and IV devices approved abroad, Registration of a class III or IV 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.