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Lecciones de los sistemas globales de materiovigilancia: ¿Qué puede aprender la India?
Aditya Vikram Singh1, Farida Ahmad1, Syed Shariq Naeem1
1Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
Perspectives in clinical research
|February 16, 2026
Resumen
La materiovigilancia, la monitorización de los eventos adversos de los dispositivos médicos, es crucial para la seguridad del paciente. Las naciones desarrolladas tienen sistemas sólidos, mientras que la India
Área de la Ciencia:
- Seguridad de dispositivos médicos y ciencia regulatoria.
- Salud pública y fortalecimiento del sistema de atención médica.
Sus antecedentes:
- Los dispositivos médicos son vitales en la atención médica, pero conllevan riesgos de defectos y eventos adversos.
- La materiovigilancia es esencial para monitorear, evaluar y prevenir daños relacionados con dispositivos médicos.
- Los países desarrollados tienen sistemas de materiovigilancia maduros con una sólida supervisión regulatoria y de notificación.
Objetivo del estudio:
- Analizar el estado actual de la materiovigilancia a nivel mundial y en la India.
- Identificar los desafíos en el programa de materiovigilancia en evolución de la India.
- Proponer estrategias para fortalecer el marco de seguridad de los dispositivos médicos de la India.
Principales métodos:
- Análisis comparativo de las mejores prácticas internacionales de materiovigilancia.
- Revisión del Programa de Materiovigilancia de la India (2015).
- Identificación de desafíos que incluyen la notificación, la concienciación y la aplicación.
Principales resultados:
- Los países establecidos utilizan una vigilancia postcomercialización integral, enfatizando la notificación en tiempo real y la rendición de cuentas.
- El programa de la India enfrenta desafíos: notificación obligatoria limitada, baja concienciación, notificación insuficiente y aplicación inconsistente.
- Las mejores prácticas globales ofrecen una hoja de ruta para la mejora de la materiovigilancia de la India.
Conclusiones:
- El fortalecimiento de la materiovigilancia de la India requiere una mejor infraestructura de notificación y la participación de las partes interesadas.
- Las políticas regulatorias mejoradas y la aplicación son críticas para garantizar la seguridad de los dispositivos médicos en la India.
- La adopción de las mejores prácticas globales puede fortalecer significativamente la seguridad y la confiabilidad de los dispositivos médicos de la India.
Palabras clave:
Eventos adversosPrograma de Materiovigilancia de la Indiamateriovigilanciadispositivo médicoregulatoriovigilanciaMás Videos Relacionados
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