For many regulatory professionals, performing an Anvisa AFE consultation is a routine task. But the Brazilian agency has just announced an important update!
From now on, Operating Authorization (AFE) and Special Authorization (AE) certificates will be issued automatically through the Solicita system.
This change reduces manual steps, minimizes rework, and shortens processing times — modernizing a key stage in the relationship between companies and the Agency.
For those who closely follow how the Anvisa AFE consultation works, this move confirms the growing trend toward digitalization and standardization of regulatory processes in Brazil.
What changes in practice for those who depend on AFE/AE
Before this update, certificate issuance required a manual check after approval.
Now, with automation in Solicita, the system immediately generates the certificate once it approves the request — no additional intervention required.
For professionals managing Anvisa AFE consultation on a daily basis, this means:
- Faster response times and more predictable processing;
- Standardized and transparent procedures;
- Easy access to the certificate in the user area;
- Fewer errors and rework, as the system integrates directly with Anvisa’s databases.
This update reinforces Anvisa’s commitment to modernizing its workflows and expanding the use of digital solutions — a direction that aligns with other initiatives such as electronic submissions and automated publications in the Official Gazette.
Why companies perform an Anvisa AFE consultation
The Anvisa AFE consultation tool is one of the most frequently accessed by regulated companies in Brazil, especially in the medical device and IVD sectors.
It allows organizations to verify the status of their Operating Authorization, a mandatory document for manufacturers, importers, distributors, and storage facilities of products subject to sanitary control to legally operate in the country.
Through this consultation, companies can:
- Confirm if their AFE is valid or approved;
- Check whether there are pending, suspended, or canceled processes;
- Demonstrate compliance to clients and commercial partners;
- Avoid administrative sanctions, such as warnings or suspensions.
Until recently, obtaining and updating an AFE involved manual steps and waiting for the formal issuance of the certificate after process approval.
Now, with Solicita, the certificate is issued automatically, eliminating the gap between approval and document generation — making the Anvisa AFE consultation process faster and more reliable.
Why automation of AFE/AE matters for the regulated sector
Manufacturers, importers, and distributors of medical devices, cosmetics, and IVDs rely on predictability to plan product launches and imports.
By automating certificate issuance, Anvisa reduces operational risks and increases confidence in publicly available information.
For professionals searching “Anvisa AFE consultation” to regularize their operations or update records, this change represents less bureaucracy, more transparency, and greater efficiency.
International overview: convergence, AI, and clinical trials
While Anvisa advances automation in AFE/AE, other regulatory authorities worldwide are also moving forward:
FDA: Public consultation on AI and E20 guideline
The U.S. FDA opened a Request for Public Comment to gather practical insights on evaluating the performance of AI-enabled medical devices, including strategies to monitor and manage performance drift.
Additionally, the FDA released the E20: Adaptive Designs for Clinical Trials guideline, which provides recommendations for using flexible statistical methods in clinical studies — helping to reduce costs and accelerate innovation.
NMPA and HSA partnership
China’s National Medical Products Administration (NMPA) met with Singapore’s Health Sciences Authority (HSA) to discuss medical device regulatory frameworks and strengthen mutual trust. This initiative is part of China’s broader strategy to harmonize regulatory standards with neighboring countries.
Together, these advances show how different authorities — including Anvisa — are modernizing processes and integrating technologies to keep pace with scientific and digital evolution.
Milestones of modernization
As you can see, this has been an important period for the global regulatory landscape.
The automation of the Anvisa AFE consultation marks a key step toward regulatory efficiency.
Companies now benefit from a faster, more reliable, and integrated system that reduces bureaucracy and strengthens legal certainty.
For the regulated sector, this evolution reinforces the need to closely follow every new update from Anvisa, ensuring that internal processes, records, and submissions remain aligned with the latest practices.
At Sobel, we understand that keeping up with all these changes can be complex.
That’s why our team continuously monitors Anvisa and other global authorities, ensuring that our partners are always well-informed.
By connecting international trends with local regulatory practices, we help companies stay one step ahead of regulation.
Need support in your regulatory journey? Count on Sobel.
