{"id":41379,"date":"2016-03-14T22:54:54","date_gmt":"2016-03-15T02:54:54","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/"},"modified":"2021-07-27T08:54:57","modified_gmt":"2021-07-27T12:54:57","slug":"fda-medical-devices","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-medical-devices\/","title":{"rendered":"Dispositifs m\u00e9dicaux"},"content":{"rendered":"
[vc_section el_id=”pageHero” css=”.vc_custom_1581878044647{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/md-hero.jpg?id=41288) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” el_class=”page-solutions”][vc_row el_class=”page-marquee”][vc_column][vc_column_text el_class=”half-width”]\n

Dispositifs m\u00e9dicaux<\/h1>\n
\n

S\u2019enregistrer avec l\u2019U.S. Food and Drug Administration (FDA)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Commencer<\/span><\/div>
<\/div><\/a>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”hero-footer”][vc_column][vc_raw_html]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[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=”featuredSolutions”][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878657161{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/01\/guidance-on-medical-device.jpg?id=40116) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Enregistrement d\u2019\u00e9tablissement
\net de produits<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Les propri\u00e9taires ou op\u00e9rateurs de toute entreprise impliqu\u00e9e dans la production et la distribution de dispositifs m\u00e9dicaux pr\u00e9vus pour l\u2019usage aux \u00c9tats-Unis ont l\u2019obligation de s\u2019enregistrer avec la FDA annuellement. Les entreprises impliqu\u00e9es dans la production, le packaging, l\u2019\u00e9tiquetage, ou le retraitement de dispositifs doivent payer des frais annuels. Beaucoup d\u2019\u00e9tablissements qui ont l\u2019obligation de s\u2019enregistrer avec la FDA doivent aussi enregistrer leurs dispositifs (listings).[\/vc_column_text][vc_column_text el_class=”side-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]La plupart des dispositifs m\u00e9dicaux distribu\u00e9s aux \u00c9tats-Unis ont l\u2019obligation d\u2019inclure un code num\u00e9rique ou alphanum\u00e9rique comme identifiant de dispositif unique (unique device identifier \u2013 UDI). La FDA exige aussi la soumission du dispositif et des informations UDI \u00e0 la base de donn\u00e9es Global Unique Device Identifier Database (GUDID).[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581878635150{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/06\/developments-in-udi.jpg?id=40031) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

UDI et
\nGUDID<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878753081{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Rapport \u00e9lectronique de
\ndispositif m\u00e9dical (eMDR)<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]La FDA exige d\u00e9sormais que les fabricants et importateurs de dispositifs m\u00e9dicaux soumettent des rapports d\u2019effets ind\u00e9sirables dans un format \u00e9lectronique. Les fabricants de dispositifs et importateurs ont l\u2019obligation de soumettre des rapports d\u2019effets ind\u00e9sirables \u00e0 la FDA quand des preuves sugg\u00e8rent qu\u2019un dispositif ait pu contribu\u00e9 \u00e0 la mort d\u2019un patient ou une blessure s\u00e9rieuse, ou qu\u2019un dysfonctionnement du dispositif, ou la r\u00e9apparition de ce dysfonctionnement, pourrait contribu\u00e9 au d\u00e9c\u00e8s d\u2019un patient ou \u00e0 des blessures s\u00e9rieuses.[\/vc_column_text][vc_column_text el_class=”side-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]Un Master File de dispositif m\u00e9dical est une soumission \u00e0 l\u2019U.S. FDA qui peut \u00eatre utilis\u00e9e \u00e0 l\u2019appui de soumissions pr\u00e9alables \u00e0 la commercialisation pour fournir des informations confidentielles d\u00e9taill\u00e9es \u00e0 propos des \u00e9tablissements, process, ou articles utilis\u00e9s pendant la fabrication, le traitement, le packaging ou le stockage d\u2019un dispositif m\u00e9dical ou plus. L\u2019\u00e9quipe d\u2019experts r\u00e8glementaires pour les dispositifs m\u00e9dicaux de Registrar Corp fournit des conseils \u00e0 propos des \u00e9l\u00e9ments requis, des formats et particularit\u00e9s des soumissions de Master File de dispositif m\u00e9dical.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581878724416{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/09\/veterinary-master-files.jpg?id=39982) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Master File
\nde dispositif m\u00e9dical<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=”.vc_custom_1574176315943{background-color: #ececec !important;}”][vc_row equal_height=”yes” el_class=”grid-tiles”][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581878983891{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/04\/9-of-medical-device.jpg?id=39918) !important;}” el_class=”grid-tile-title hasImage”]\n

V\u00e9rification d\u2019\u00e9tiquetage
\net d\u2019ingr\u00e9dients<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les erreurs d\u2019\u00e9tiquetage sont une des plus grandes causes de d\u00e9tention par la FDA. Registrar Corp aide les entreprises \u00e0 modifier leurs \u00e9tiquetages de dispositifs m\u00e9dicaux pour satisfaire les r\u00e8glementations FDA. Registrar Corp fournit des fichiers graphiques pr\u00eats \u00e0 \u00eatre imprim\u00e9s ou modifi\u00e9s ainsi qu\u2019un rapport qui d\u00e9taille les r\u00e9glementations, guides de conformit\u00e9, lettres d\u2019avertissements, alertes d\u2019importations et autres documents de r\u00e9f\u00e9rence \u00e9mis par l\u2019U.S. FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1582657418607{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41655) !important;}” el_class=”grid-tile-title hasImage”]\n

Exigences pour les colorants<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Un colorant de dispositif m\u00e9dical est tout pigment, teinture, ou autre substance qui peuvent donner de la couleur \u00e0 un dispositif m\u00e9dical. Les colorants de dispositifs m\u00e9dicaux sont r\u00e9gul\u00e9s par la FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581878811308{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}” el_class=”grid-tile-title hasImage”]\n

Assistance d\u00e9tention<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les entreprises envoyant des produits vers les \u00c9tats-Unis peuvent avoir leurs cargaisons sujettes \u00e0 la d\u00e9tention sans examen physiques (Detention without physical examination \u2013 DWPE) par la FDA. Les produits sujets \u00e0 la DWPE sont d\u00e9tenus au port d\u2019entr\u00e9e pendant que la FDA effectue des examens minutieux, tests, et analyse additionnels. Les retards d\u00fbs \u00e0 la DWPE peuvent \u00eatre longs pour les entreprises devant livrer leurs produits dans les d\u00e9lais.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-offset-4 vc_col-lg-4 vc_col-md-offset-3 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581878858045{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}” el_class=”grid-tile-title hasImage”]\n

Certificats d’exportations aux gouvernements \u00e9trangers<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les clients et gouvernements \u00e9trangers demandent souvent aux entreprises exportant des produits depuis les \u00c9tats-Unis de fournir un \u201cExport Certificate\u201d (certificat d\u2019exportation) pour les produits r\u00e9gul\u00e9s par l\u2019U.S. FDA. Un Certificat d\u2019Exportation est un document pr\u00e9par\u00e9 par l\u2019U.S. FDA contenant des informations sur le statut r\u00e8glementaire ou marketing d\u2019un produit.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

<\/i><\/i><\/div><\/div><\/div>
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<\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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