Brazil · Brazilian Health Regulatory Agency · Software as a medical device
Review target
250 days
regulation
Legal time limit
-
Not published
Steps
4
6 requirements
Application fee
-
Software that meets the medical device definition and runs without being part of device hardware follows the general device rules. Classes I and II are notified, classes III and IV registered. Decision support software is class II, or class III or IV when wrong decisions could cause serious harm or death. Software built in-house by a health service for its own use in classes I and II does not need regularization. Standalone medical software, including mobile apps and software as a service. Embedded software is regularized together with its device.
The official review target is 250 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Classify the software; 2. Notification (class I or II) or registration (class III or IV); 3. Processing or review; 4. Publication.
Outcome: Notification or registration published; selling with an expired or cancelled regularization is not allowed.
Legal basis: Anvisa RDC 657/2022; Anvisa RDC 751/2022
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 250 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. Registration of medical software (classes III and IV). Notifications: 30 days. | 250 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Brazil: Good manufacturing practice certification (CBPF), 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. 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.