Brazil ANVISA Announces Priorities for the 2024-2025 Year

By Luiz Levy, Priscila Sanada and Evangeline Loh

Brazil’s medical device market regulator, ANVISA, announced its priorities in the “Regulatory Agenda” for the 2024-2025 year. The document was approved in December 2023. The 172 topics and 66 themes are aligned with their three-year plan.

Emergo by UL highlighted five topics on the ANVISA Regulatory Agenda

During the Emergo by UL webinar on Brazil Regulatory Updates, five of these topics from Section 11 were highlighted as seminal to medical devices in the upcoming two years.

Critical to medical devices in near future:

• E-labeling for layperson use (Instruções de uso em formato eletrônico para dispositivos médicos de uso leigo, 11.3)
• Medical device reprocessing (Reprocessamento de Dispositivos Médicos, 11.7)
• Revision of the software regulation (Revisão da regularização de software como dispositivo médico (Software as a Medical Device - SaMD) (Revisão da RDC nº 657/2022), 11.8)
• Review of the Essential Safety and Effectiveness Requirements for Medical Devices (Revisão dos Requisitos Essenciais de Segurança e Eficácia para Dispositivos Médicos, 11.10)
• Update on INMETRO certification rules (Atualização periódica da certificação de equipamentos sob regime de vigilância sanitária, no âmbito do Sistema Brasileiro de Avaliação da Conformidade (SBAC), 11.11)

e-Labeling for layperson use

Resolution RDC 751/2022 permits e-labeling, non-printed format “Formato Não Impresso” (Articles 50-54), however, Article 54 is explicit that it is not for devices for layperson use. One of the priority topics is for ANVISA to further propose legislation for e-IFU with medical devices for layperson use. This new legislation will dictate the readability, format and provision for access of e-IFUs.

Medical device reprocessing

The topic of medical device reprocessing has been controversial, and ANVISA has hosted public consultations that have not yielded legislation. A manufacturer’s self-declaration of “single-use” is insufficient. For a medical device to be qualified as “single-use”, the device material must be either be listed in RE 2606/2006 or the manufacturer must submit objective evidence to support that the device cannot be reprocessed due to due to compromised cleaning, disinfection or sterilization, as well as loss of performance and functionality and integrity. If it meets the requirement, the device must be labeled as “Reprocessing prohibited” per RDC 156/2006.

We expect ANVISA to issue another public consultation to propose the removal of RE 2606/2006 and change the criteria to a risk-based approach supported by the information listed above.

Revision of the software regulation

ANVISA has proposed a revision of RDC 657/2022. This is expected to include specific regulatory document requirements, content about design verification and cybersecurity assessment.

Review of the Essential Safety and Effectiveness Requirements for Medical Devices

An update to RDC 546/2021 on the Essential Safety and Effectiveness Requirements to further align with the European Medical Devices Regulation (2017/745, MDR) Annex I, General Safety Performance Requirements. This is expected to be minor changes, though specific provisions related to medical device usability will be added.

ANVISA has now indicated that the ANVISA Directors will discuss at their first Board of Directors meeting in 2024 (February 21) the proposal for a resolution related to the essential safety and performance requirements applicable to medical devices and IVDs.

This is exciting as ANVISA will revise the RDC that deals with Essential Safety and Efficacy Requirements for Medical Devices (material and equipment) but will also discuss a proposal to create a Resolution for Essential Safety and Efficacy Requirements for IVDs.

Update on INMETRO certification rules

For manufacturers with devices with compulsory technical standards (identified in Normative Instruction No. 116/2021) and Ordinance No. 384/2020 for which INMETRO, certification is required, there are proposed changes to update the standard list required for the certification.  As soon as ANVISA publishes the revision of IN 116/2021, ANVISA expects INMETRO certification bodies to immediately request an updated test report for the standards listed without an extension period to comply with the new Normative Instruction. If the manufacturer doesn’t produce this, the INMETRO certificate will be canceled, as well as the ANVISA registration (or notification).

A draft of this proposal, while not publicly available, has already been circulated among the INMETRO certification bodies.

Concluding remarks

In addition to the two consultations announced in September (Consulta Pública n 1200/2023) and October (Consulta Pública n 1208/2023) of last year, to leverage regulatory authorizations and extend the use of MDSAP certificates for B-GMP certificates to four years, respectively, there are many regulatory developments expected in the next year.

Emergo by UL will continue to monitor and report on these regulatory developments.