ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

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A TGA australiana publicou um guia atualizado sobre a regulamentação de software e IA com fins médicos. Descubra os requisitos de conformidade, riscos e oportunidades para fabricantes e desenvolvedores de dispositivos médicos digitais.

The proposed revision of IEC 62304 brings important changes for the development of software for medical devices and other healthcare applications. The new version expands the concept of Health Software to include solutions that assist in health management and monitoring, even without being classified as medical devices. Among the main changes are the simplification of the classification of software rigor, the removal of specific Quality System requirements and the revision of Risk Management, which no longer requires ISO 14971. In addition, the approach to legacy software will be reformulated, with guidelines transferred to an informative annex. As this update is still in the proposal stage, manufacturers should keep an eye on the changes and prepare for future adaptations.