{"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":"reglement-sur-les-masques-faciaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/face-mask-regulations\/","title":{"rendered":"Guide sur les r\u00e9glementations relatives aux masques faciaux pendant la p\u2026"},"content":{"rendered":"

Comment les masques faciaux sont-ils r\u00e9glement\u00e9s ?<\/h2>\n

Bien que les r\u00e9glementations relatives aux masques faciaux varient selon les pays ou les r\u00e9gions, la conformit\u00e9 d\u00e9pend \u00e9galement du type de masque facial et de la mani\u00e8re dont il est commercialis\u00e9.<\/p>\n

Les masques chirurgicaux et les respirateurs sont le plus souvent r\u00e9glement\u00e9s comme des dispositifs m\u00e9dicaux, tandis que les masques communautaires, con\u00e7us pour un usage personnel, ne sont en grande partie pas r\u00e9glement\u00e9s.<\/p>\n

 <\/p>\n

\"Image<\/p>\n

<\/h2>\n

Directives r\u00e9glementaires temporaires<\/h2>\n

La Chine a renforc\u00e9 ses mesures d\u2019application de la loi.<\/h4>\n

En raison d'une augmentation des produits contrefaits et de qualit\u00e9 inf\u00e9rieure, la Chine a temporairement impos\u00e9 des exigences r\u00e9glementaires suppl\u00e9mentaires sur cinq types de dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre export\u00e9s, notamment les kits de test COVID-19, les masques chirurgicaux, les v\u00eatements chirurgicaux de pr\u00e9vention, les ventilateurs et les thermom\u00e8tres infrarouges.<\/p>\n

\u00c0 l\u2019inverse, les \u00c9tats-Unis ont assoupli les restrictions.<\/h4>\n

Pour permettre une augmentation des stocks d'EPI, la FDA et le CDC am\u00e9ricains ont assoupli les r\u00e9glementations d'importation. Les masques en provenance de Chine peuvent \u00eatre autoris\u00e9s \u00e0 entrer aux \u00c9tats-Unis dans le cadre d'une autorisation d'utilisation d'urgence existante. La FDA est \u00e9galement ouverte \u00e0 la collaboration avec des fabricants d'EPI qui ne sont pas actuellement sur le march\u00e9 am\u00e9ricain, ou avec des entreprises qui cherchent \u00e0 se r\u00e9orienter pour fabriquer des masques faciaux et d'autres EPI.
\nLes allocations temporaires europ\u00e9ennes ont expir\u00e9.
\nEn Europe, les restrictions r\u00e9glementaires ont \u00e9t\u00e9 bri\u00e8vement assouplies pour optimiser la cha\u00eene d\u2019approvisionnement et permettre l\u2019afflux de fournitures. La plupart des autorisations temporaires ont \u00e9t\u00e9 en vigueur pendant 30 jours et ont depuis expir\u00e9. De nombreux pays europ\u00e9ens ont \u00e9t\u00e9 touch\u00e9s par des produits contrefaits et l\u2019UE h\u00e9site donc \u00e0 assouplir \u00e0 nouveau les restrictions.<\/p>\n

 <\/p>\n

Comment nous avons aid\u00e9 une entreprise d'EPI \u00e0 se d\u00e9velopper sur de nouveaux march\u00e9s<\/h2>\n

Une entreprise japonaise de premier plan dans le domaine des dispositifs m\u00e9dicaux souhaitait \u00e9tendre sa gamme de masques faciaux \u00e0 l'Europe pendant la pand\u00e9mie de coronavirus. Le client souhaitait inclure une mention antipollution sur l'\u00e9tiquette.<\/p>\n

RegASK a travaill\u00e9 avec ses experts sur le terrain poss\u00e9dant une connaissance approfondie de l'UE pour garantir l'entr\u00e9e des produits dans le plus grand nombre de pays possible.<\/p>","protected":false},"excerpt":{"rendered":"

How are face masks regulated? While the regulations for face masks will vary by country or region, compliance also depends on the type of face mask and the way it is marketed. Surgical masks and respirators are regulated most often as medical devices, whereas community masks, designed for personal use, are largely unregulated.   Temporary…<\/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, 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