Approval routes, expedited programs and designations, with steps, official time targets, fees and reliance. Last verified October 3, 2026.
Routes on this page
22
Reviewed
Product types
9
Drugs, devices and more
Shortest review target
30 days
Notification of a class I or II medical device
Approvals in the data
225,233
As of October 3, 2026
Brazil has 22 reviewed approval routes and programs on this page. The main routes for new medicines are Registration of a new medicine, Registration of an innovative medicine, Registration of a new biological product (individual development route).
Among the routes with an official review target, Notification of a class I or II medical device has the shortest target: 30 days. Targets are not actual review times.
Yes. Optimized analysis using an equivalent foreign authority relies on AU, CA, CH, EU, GB, JP, US, WHO; Optimized analysis for class III and IV devices approved abroad relies on AU, CA, JP, US.
7 routes
Full registration for a synthetic or semisynthetic medicine with a new molecule, meaning a new active ingredient or an analog not yet registered in Brazil. Anvisa reviews quality, safety and efficacy before the medicine can be sold.
Full application, new active substance · verified October 3, 2026
Registration for an improvement on a medicine already registered as new in Brazil, such as a new combination, new route, new strength, new dosage form, new pack or new indication. Evidence can come from clinical and nonclinical studies, comparative studies or published technical and scientific data.
Full or mixed application, known active substance · verified October 3, 2026
Registration petitions that meet public health criteria get a legal maximum of 120 days instead of 365. The agency checks eligibility within 45 days. Medicines registered with priority must reach the market within 365 days or the registration is cancelled.
Priority or accelerated review · verified October 3, 2026
A fixed sequence for new medicines for rare diseases: a pre-submission meeting within 60 days of request, filing within 30 days of the meeting, a first review within 60 days, 30 days for the company to answer and 45 days for the final check. Phase II data with phase III ongoing can be accepted, and data can follow under a commitment term.
Orphan or rare disease designation · target 60 days · verified October 3, 2026
Anvisa may grant registration with open items when public health benefits outweigh the risks. Items that are not low risk need a signed commitment term. Such registrations start with 3 years of validity, then 5 years after the first renewal and 10 after the second. New biologics for serious or high mortality diseases may be filed with phase II done and phase III ongoing.
Conditional or accelerated approval · verified October 3, 2026
For medicines, vaccines, biologics and active ingredient letters already approved by at least one equivalent foreign authority, Anvisa can use that authority's assessment and run a verified review instead of a full one. Items specific to Brazil still get an ordinary review, and Anvisa decides on its own.
Reliance route, abridged review · relies on AU, CA, CH, EU, GB, JP, US, WHO · verified October 3, 2026
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.
Other route · target 365 days · verified October 3, 2026
1 routes
Registration of a biological medicine, including vaccines, hyperimmune sera, blood products, biotech medicines and monoclonal antibodies. A product with a molecule not yet registered in Brazil, or one developed alone, needs a complete dossier with phase I, II and III clinical data.
Full application, new active substance · verified October 3, 2026
1 routes
A biosimilar is a biological medicine highly similar to a comparator already registered by Anvisa on a complete dossier. The company runs a stepwise comparability exercise: analytical, then nonclinical and clinical studies, all comparative.
Biosimilar application · verified October 3, 2026
2 routes
Registration of a copy of a reference medicine that is meant to be interchangeable with it. The generic is named by the Brazilian nonproprietary name. The company shows pharmaceutical equivalence and bioequivalence.
Generic application · verified October 3, 2026
Registration of a branded copy of a medicine already registered with Anvisa. It has the same active ingredients, strength, dosage form, route, dosing and indication and must always carry a brand or trade name. The evidence package is the same as for generics.
Generic application · verified October 3, 2026
2 routes
Low-risk, non-prescription medicines on an official list are notified electronically instead of registered. After the fee is paid and the notification is activated, the medicine may be sold at once. There is no prior dossier review.
Non-prescription monograph · verified October 3, 2026
A company asks Anvisa to classify a medicine as non-prescription. The decision is made by updating the official list of non-prescription medicines, approved by the agency board. Companies then update their registrations within 180 days.
Non-prescription application · verified October 3, 2026
3 routes
Advanced therapy products are a special category of new medicines: advanced cell therapy, tissue engineered products and gene therapy. Class I covers minimally manipulated cells used for a different function; class II covers extensively manipulated cells, tissue engineering and gene therapy. The first registration lasts 5 years.
Full application, new active substance · verified October 3, 2026
As an exception, Anvisa can register an advanced therapy product before full efficacy data exist. The company signs a commitment term with a clinical study schedule and reports every year. The agency has 120 days to decide.
Conditional or accelerated approval · verified October 3, 2026
An advanced therapy made non-routinely for a specific patient in imminent life threat, with no alternative in Brazil, is not registered. Cell and tissue products need a prior notice to Anvisa; gene therapy needs prior authorization, which Anvisa answers within 30 days. These products cannot be sold.
Early or compassionate access · verified October 3, 2026
3 routes
Low and medium risk devices (classes I and II) are notified, not registered. There is no technical review before the product is regularized; the agency routinely processes a notification within 30 days. The technical dossier stays with the company for inspection. Notifications do not need renewal.
Device: premarket notification · target 30 days · verified October 3, 2026
High and maximum risk devices (classes III and IV) need registration after a technical review of the dossier. Approval also waits for an Anvisa GMP certificate. The response targets are 250 days for equipment and software and 320 days for medical materials. Registration lasts 10 years.
Device: registration or licence with the regulator · target 320 days · verified October 3, 2026
Registration petitions for class III and IV devices and IVDs already authorized in Australia, Canada, the United States or Japan can be reviewed using the foreign authorization. The petition keeps its place in the queue, and Anvisa can still choose the ordinary review.
Reliance route, abridged review · relies on AU, CA, JP, US · verified October 3, 2026
2 routes
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.
Device: premarket notification · target 30 days · verified October 3, 2026
IVDs in classes III and IV need registration after a technical review, with a response target of 365 days. The dossier covers performance studies, stability on at least three lots and clinical performance where relevant. Registration waits for an Anvisa GMP certificate and lasts 10 years.
Device: registration or licence with the regulator · target 365 days · verified October 3, 2026
1 routes
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.
Device: registration or licence with the regulator · target 250 days · verified October 3, 2026
Recent changes and pending reforms
Compare Brazil with: United States, European Union, United Kingdom, Japan, China, Germany, France, Italy.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.