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Finaliza la declaratoria como Vital No Disponible (VND) para las mascarillas y/o tapabocas convencionales para la atención hospitalaria o de uso médico

Según publicación de la Sala Especializada de DM y RDIV, del 11 de septiembre, finaliza la de-claratoria temporal como VND para las mascarillas y/o tapabocas convencionales indicados para la prevención o protección de la vía aérea contra microorganismos generados en la atención hospitalaria o aquellos de uso médico.

Por lo tanto, para su importación, fabricación y/o comercialización en el país deberán contar con Registro Sanitario.

Los fabricantes o importadores con trámites en curso contarán con treinta (30) días calendario, (a partir del 11 de septiembre), para culminar sus procesos de aprobación, de importación y fabricación. Una vez finalice este periodo de transición NO se podrán importar, ni fabricar estos Dispositivos Médicos sin su respectivo Registro Sanitario.

Las mascarillas y/o tapabocas fabricados o importados antes de esta decisión, podrán agotar sus existencias hasta el cumplimiento de su vida útil, con solo notificarlo al lnvima, de acuerdo con el procedimiento que se establezca.

Los Respirador es N95, R95, P95 (Estados Unidos); FFP2 o FFP3 (Brasil y Europa); FFP2 (Australia y Nuevo Zelanda); KN95, KP95 (China); DS2, DL2 (Japón); AP2 (India); Corea – 1era clase; y todos aquellos que cumplan con los estándares de seguridad y eficacia equivalentes a una alta eficencia de filtración de partículas igual o superior al 95% y, que su indicación de uso sea la prevención o protección de la vía aérea contra microorganismos generados en la atención hospitoloria o aquellos de uso médico, continuarán con su condición temporal de Dispositivos Médicos Vitales No Disponibles y para su fabricación, importación y/o comercialización en el país se deberá cumplir con lo establecido en el Decreto 1148 de 2020.

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