A Busy Few Months for Brazil ANVISA

By Luiz Levy, Priscila Sanada and Evangeline Loh

Update on ANVISA Regulatory Agenda

The medical device regulator in Brazil, ANVISA, has been progressing through their 2024-2025 “Regulatory Agenda” priorities.

Since the first ANVISA Board of Directors meeting (February 21), ANVISA has maintained a fast-paced momentum in advancing legislation and addressing priorities.

Essential safety and performance requirements for medical devices and IVDs

True to their commitment, ANVISA first released (March 6) Resolution RDC 848/2024 on the Essential Safety and Performance Requirements (ESPR) to apply to both medical devices and IVDs. This has previously not been applied to IVDs. In 180 days, RDC 848/2024 will apply to medical devices and IVDs and RDC 546/2021 will be revoked.

Medical devices and IVDs will need to be developed compliant with RDC 848/2024 and the technical documentation in regulatory submissions (notification and registro) will need to include ESPR Checklists.

Two consultations in Q4 2023 yield legislation

Two consultations from September and October 2023 led swiftly to legislative reform. After the public consultation period ended, ANVISA efficiently released the new laws.  

RDC 850/2024 (March 20) amends RDC 497/2021 and effective the first of April, extends Brazil GMP certificates for manufacturers who possess a Medical Device Single Audit Program (MDSAP) certificate, from two to four years.

Normative Instruction IN 290/2024 (April 8) announced the process to leverage regulatory authorizations from the four former Global Harmonization Task Force (GHTF) founding members or Equivalent Foreign Regulatory Authority (AREE), when the identical device is also being registered with ANVISA. Leveraging becomes an option on June 3.

These are both exciting developments that signal ANVISA’s commitment to global regulatory harmonization, as well as their priorities.

Guidance to RDC 830/2023

The IVD resolution was released in December 2023, RDC 830/2023.  RDC 830/2023 becomes effective June 1. To this end, at the end of March, ANVISA released three guidance documents to facilitate the assessment of risk classification of IVDs.  

Concluding remarks

ANVISA has been busy. In a short period, ANVISA has released seminal legislation and guidance: two RDCs, one IN and three guidance documents.

We at Emergo by UL will continue to monitor and share medical device regulatory developments in Brazil. If you are attending Hospitalar, the main trade fair in Latin America (May 21-24), meet us at booth # H-169 to further discuss your regulatory consulting needs.