{"id":8263,"date":"2018-11-14T14:06:56","date_gmt":"2018-11-14T13:06:56","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8263"},"modified":"2023-01-24T15:05:20","modified_gmt":"2023-01-24T14:05:20","slug":"corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/","title":{"rendered":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-8257 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\" alt=\"\" width=\"300\" height=\"185\" \/><\/p>\n<p>Con el objetivo de armonizar las Buenas Pr\u00e1cticas de Fabricaci\u00f3n de Corea (KGMP) con los requisitos de la norma ISO 13485:2016, la Autoridad Reguladora de Corea del Sur (<em>Ministry of Food and Drug Safety &#8211; MFDS<\/em>) \u00a0emiti\u00f3 el 1 de octubre de 2018 la Notificaci\u00f3n No. 2018 &#8211; 409 <a href=\"http:\/\/mfds.go.kr\/brd\/m_209\/view.do?seq=42961&amp;srchFr=&amp;srchTo=&amp;srchWord=%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0&amp;srchTp=0&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1\"><em>\u00abManufacture and Quality Control Standards for Medical Devices (Food and Drug Administration Notice 2016-156)\u00bb<\/em><\/a>.<\/p>\n<p>Mediante la alineaci\u00f3n de las KGMP con la norma armonizada para sistemas de gesti\u00f3n de calidad de dispositivos m\u00e9dicos, ISO 13485: 2016, el MFDS pretende mejorar el proceso de control de calidad y establecer criterios m\u00e1s estrictos y claros para las auditor\u00edas.<\/p>\n<p>Adem\u00e1s, esta transici\u00f3n hacia los requisitos de la norma ISO 13485:2016 abrir\u00eda el camino para que Corea del Sur sea incluida en el Programa MDSAP.<\/p>\n<p>La notificaci\u00f3n se encuentra actualmente en fase de consulta p\u00fablica y el MFDS aceptar\u00e1 cualquier comentario de las partes interesadas sobre las medidas propuestas hasta finales de noviembre de 2018.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Con el objetivo de armonizar las Buenas Pr\u00e1cticas de Fabricaci\u00f3n de Corea (KGMP) con los requisitos de la norma ISO 13485:2016,  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-8263","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"Con el objetivo de armonizar las Buenas Pr\u00e1cticas de Fabricaci\u00f3n de Corea (KGMP) con los requisitos de la norma ISO 13485:2016, [...]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:published_time\" content=\"2018-11-14T13:06:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T14:05:20+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#article\",\"isPartOf\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016\",\"datePublished\":\"2018-11-14T13:06:56+00:00\",\"dateModified\":\"2023-01-24T14:05:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\"},\"wordCount\":175,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"image\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\",\"articleSection\":[\"Noticias\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\",\"url\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\",\"name\":\"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage\"},\"image\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\",\"datePublished\":\"2018-11-14T13:06:56+00:00\",\"dateModified\":\"2023-01-24T14:05:20+00:00\",\"breadcrumb\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage\",\"url\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\",\"contentUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"name\":\"Thema - Medical Regulatory Consultancy\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"http:\/\/www.thema-med.com\/es\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/","og_locale":"es_ES","og_type":"article","og_title":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy","og_description":"Con el objetivo de armonizar las Buenas Pr\u00e1cticas de Fabricaci\u00f3n de Corea (KGMP) con los requisitos de la norma ISO 13485:2016, [...]","og_url":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/","og_site_name":"Thema - Medical Regulatory Consultancy","article_published_time":"2018-11-14T13:06:56+00:00","article_modified_time":"2023-01-24T14:05:20+00:00","og_image":[{"url":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg","type":"","width":"","height":""}],"author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"redazione","Tiempo de lectura":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#article","isPartOf":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016","datePublished":"2018-11-14T13:06:56+00:00","dateModified":"2023-01-24T14:05:20+00:00","mainEntityOfPage":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/"},"wordCount":175,"commentCount":0,"publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"image":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage"},"thumbnailUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg","articleSection":["Noticias"],"inLanguage":"es"},{"@type":"WebPage","@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/","url":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/","name":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016 - Thema - Medical Regulatory Consultancy","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/#website"},"primaryImageOfPage":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage"},"image":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage"},"thumbnailUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg","datePublished":"2018-11-14T13:06:56+00:00","dateModified":"2023-01-24T14:05:20+00:00","breadcrumb":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#primaryimage","url":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg","contentUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/South-Korea-300x185.jpg"},{"@type":"BreadcrumbList","@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/es\/"},{"@type":"ListItem","position":2,"name":"COREA DEL SUR: Armonizaci\u00f3n de las KGMP con la ISO 13485:2016"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/es\/#website","url":"https:\/\/www.thema-med.com\/es\/","name":"Thema - Medical Regulatory Consultancy","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/es\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"http:\/\/www.thema-med.com\/es\/2018\/11\/14\/corea-del-sur-armonizacion-de-los-kgmp-con-la-iso-13485-2016\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"http:\/\/www.thema-med.com\/es\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/8263","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/comments?post=8263"}],"version-history":[{"count":1,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/8263\/revisions"}],"predecessor-version":[{"id":26928,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/8263\/revisions\/26928"}],"wp:attachment":[{"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media?parent=8263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/categories?post=8263"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/tags?post=8263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}