Análise de Alertas de Tecnovigilância e Registros de Produtos para Saúde no Brasil
Authors/Creators
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Silva, Luiz Felipe Spinola
(Researcher)1
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Cunha, Heitor Pereira Nunes Fernandes
(Researcher)1
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Trovo, Luís Octávio Custódio
(Researcher)1
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de Carvalho, Laura Bin
(Researcher)1
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Lima, Ana Julia da Silva
(Researcher)1
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Diniz, Júlia Cristina Rodrigues
(Researcher)1
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Lima, Heloísa Morais
(Researcher)1
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Passos, Beatriz Batista
(Researcher)1
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Rosa, Paloma Anselmo
(Researcher)1
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Soares, Alcimar Barbosa
(Researcher)1
- 1. Universidade Federal de Uberlândia
Description
This study presents a comparative analysis between technovigilance alerts and the registration of medical devices in Brazil. Data were obtained from the Brazilian Health Regulatory Agency (ANVISA), covering technovigilance alerts issued between July 1, 2020, and June 30, 2025. The analysis considered the number of alerts per manufacturer in relation to the total registered products, classified by risk level. The results indicate that the absolute number of alerts alone is insufficient to assess manufacturer performance, as companies with more registered products tend to accumulate more notifications. A proportional approach revealed that higher-risk devices (Classes III and IV) show lower relative alert rates, reflecting stricter quality control and regulatory requirements. These findings highlight the importance of proportional analysis in technovigilance, providing a more accurate basis for regulatory actions and decision-making in healthcare technology management.
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