{"id":1448,"date":"2020-07-13T15:21:37","date_gmt":"2020-07-13T07:21:37","guid":{"rendered":"https:\/\/regask.com\/?p=1448"},"modified":"2024-11-22T04:58:40","modified_gmt":"2024-11-21T20:58:40","slug":"normas-sobre-el-uso-de-mascarillas","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/face-mask-regulations\/","title":{"rendered":"Gu\u00eda sobre la normativa sobre el uso de mascarillas durante la pandemia de COVID-19"},"content":{"rendered":"

\u00bfC\u00f3mo se regulan las mascarillas faciales?<\/h2>\n

Si bien las regulaciones para las mascarillas faciales var\u00edan seg\u00fan el pa\u00eds o la regi\u00f3n, el cumplimiento tambi\u00e9n depende del tipo de mascarilla y la forma en que se comercializa.<\/p>\n

Las mascarillas quir\u00fargicas y los respiradores suelen estar regulados como dispositivos m\u00e9dicos, mientras que las mascarillas comunitarias, dise\u00f1adas para uso personal, en gran medida no est\u00e1n reguladas.<\/p>\n

 <\/p>\n

\"Imagen<\/p>\n

<\/h2>\n

Orientaci\u00f3n reglamentaria temporal<\/h2>\n

China ha aumentado la aplicaci\u00f3n de la ley.<\/h4>\n

Debido al aumento de productos falsificados y de calidad inferior, China impuso temporalmente requisitos reglamentarios adicionales sobre cinco tipos de dispositivos m\u00e9dicos que se exportar\u00e1n, incluidos kits de prueba de COVID-19, mascarillas quir\u00fargicas, ropa quir\u00fargica preventiva, ventiladores y term\u00f3metros infrarrojos.<\/p>\n

Por el contrario, Estados Unidos ha suavizado las restricciones.<\/h4>\n

Para permitir un aumento en los suministros de EPI, la FDA y los CDC de EE. UU. han relajado las regulaciones de importaci\u00f3n. Las mascarillas de China pueden ser elegibles para ingresar a los Estados Unidos en virtud de una autorizaci\u00f3n de uso de emergencia existente. La FDA tambi\u00e9n est\u00e1 abierta a trabajar con fabricantes de EPI que actualmente no est\u00e1n en el mercado en EE. UU. o con empresas que buscan cambiar de rumbo para fabricar mascarillas y otros EPI.
\nLas concesiones temporales de Europa han expirado.
\nEn Europa, las restricciones regulatorias se relajaron brevemente para optimizar la cadena de suministro y permitir la entrada de suministros. La mayor\u00eda de las concesiones temporales estuvieron en vigor durante 30 d\u00edas y ya expiraron. Muchos pa\u00edses europeos se vieron afectados por productos falsificados y, por lo tanto, la UE duda en volver a aliviar las restricciones.<\/p>\n

 <\/p>\n

C\u00f3mo ayudamos a una empresa de EPI a expandirse a nuevos mercados<\/h2>\n

Una importante empresa japonesa de dispositivos m\u00e9dicos quer\u00eda ampliar su l\u00ednea de mascarillas a Europa durante la pandemia de coronavirus. El cliente quer\u00eda incluir en la etiqueta una declaraci\u00f3n que impidiera la contaminaci\u00f3n.<\/p>\n

RegASK trabaj\u00f3 con sus expertos sobre el terreno con conocimiento interno de la UE para garantizar la entrada del producto en el m\u00e1ximo n\u00famero de pa\u00edses posible.<\/p>","protected":false},"excerpt":{"rendered":"

\u00bfC\u00f3mo se regulan las mascarillas? Si bien la normativa sobre mascarillas var\u00eda seg\u00fan el pa\u00eds o la regi\u00f3n, el cumplimiento tambi\u00e9n depende del tipo de mascarilla y de su comercializaci\u00f3n. Las mascarillas quir\u00fargicas y los respiradores suelen estar regulados como dispositivos m\u00e9dicos, mientras que las mascarillas comunitarias, dise\u00f1adas para uso personal, no est\u00e1n reguladas en gran medida. Temporales\u2026<\/p>","protected":false},"author":39,"featured_media":1815,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,527,514,22,519],"tags":[],"class_list":["post-1448","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-united-states-regulations","category-china-regulations","category-medical-devices","category-japan-regulations"],"acf":[],"yoast_head":"\nGuide to Face Mask Regulations During COVID-19 | RegASK<\/title>\n<meta name=\"description\" content=\"RegASK guided a PPE company through face mask regulation & compliance risk assessment by country and labeling claim substantiation, during COVID-19.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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