Supporting ANVISA: A Commitment to Innovation and Health in Brazil

By Priscila Sanada

In Brazil, Class III and IVD medical devices are submitted as a registro to the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária). In addition, substantial modifications to registros need to be reported.

Throughout 2024, we observed a significant increase in the time for ANVISA to review submissions. This is unprecedented.

Emergo by UL meets with ANVISA November 2024

In a recent meeting with the Agency, we sought to understand the reasons for this and explore how Emergo by UL could assist in facilitating these reviews.

ANVISA explained that they face a severe staff shortage. Many employees have retired, others have moved to the corporate sector, some passed away during the COVID-19 pandemic, and the Agency has been unable to replace these employees.

ANVISA needs new technicians

ANVISA, responsible for 30% of the national gross domestic product (GDP), urgently needs new technicians. The Federal Government is aware of the need; however, the selection process is public and involves candidates paying to test for the positions. Those that perform the best on the test, are awarded the technician positions.  

Delays in the review process impacts the available innovative technologies and products for treatment, diagnosis, and care of the Brazilian population.

Concluding remarks

ANVISA has been advancing Equivalent Foreign Regulatory Authority (AREE) authorizations, IN 209/2024. This is certainly anticipated to be one way to decrease the review burden placed on ANVISA.

Like ANVISA, Emergo by UL is committed to regulatory reliance. It is clear there are benefits to submitting harmonized documents to expedite the review process.   

Emergo by UL continues to engage with various associations to support ANVISA in the “New Public Competition for ANVISA” movement.