{"id":16189,"date":"2026-04-08T09:56:15","date_gmt":"2026-04-08T01:56:15","guid":{"rendered":"https:\/\/miomicon.com\/%d8%b4%d9%87%d8%a7%d8%af%d8%a9-fda-%d9%85%d9%82%d8%a7%d8%a8%d9%84-%d8%b4%d9%87%d8%a7%d8%af%d8%a9-ce-%d9%84%d9%84%d8%b9%d8%af%d8%b3%d8%a7%d8%aa-%d8%a7%d9%84%d9%84%d8%a7%d8%b5%d9%82%d8%a9-%d9%85%d8%a7\/"},"modified":"2026-07-20T01:18:04","modified_gmt":"2026-07-19T17:18:04","slug":"%d8%b4%d9%87%d8%a7%d8%af%d8%a9-fda-%d9%85%d9%82%d8%a7%d8%a8%d9%84-%d8%b4%d9%87%d8%a7%d8%af%d8%a9-ce-%d9%84%d9%84%d8%b9%d8%af%d8%b3%d8%a7%d8%aa-%d8%a7%d9%84%d9%84%d8%a7%d8%b5%d9%82%d8%a9-%d9%85%d8%a7","status":"publish","type":"post","link":"https:\/\/miomicon.com\/ar\/%d8%b4%d9%87%d8%a7%d8%af%d8%a9-fda-%d9%85%d9%82%d8%a7%d8%a8%d9%84-%d8%b4%d9%87%d8%a7%d8%af%d8%a9-ce-%d9%84%d9%84%d8%b9%d8%af%d8%b3%d8%a7%d8%aa-%d8%a7%d9%84%d9%84%d8%a7%d8%b5%d9%82%d8%a9-%d9%85%d8%a7\/","title":{"rendered":"\u0634\u0647\u0627\u062f\u0629 FDA \u0645\u0642\u0627\u0628\u0644 \u0634\u0647\u0627\u062f\u0629 CE \u0644\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629: \u0645\u0627 \u064a\u062d\u062a\u0627\u062c \u0645\u0627\u0644\u0643\u0648 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629 \u0625\u0644\u0649 \u0645\u0639\u0631\u0641\u062a\u0647"},"content":{"rendered":"<p>\u064a\u064f\u0639\u062f\u0651 \u0641\u0647\u0645 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f \u0623\u0645\u0631\u064b\u0627 \u0628\u0627\u0644\u063a \u0627\u0644\u0623\u0647\u0645\u064a\u0629 \u0644\u0623\u0635\u062d\u0627\u0628 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629 \u0644\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629. \u064a\u0645\u062b\u0651\u0644 \u0627\u0639\u062a\u0645\u0627\u062f FDA (\u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629) \u0648\u0627\u0639\u062a\u0645\u0627\u062f CE (\u0623\u0648\u0631\u0648\u0628\u0627) \u0623\u0647\u0645 \u0627\u0639\u062a\u0645\u0627\u062f\u064a\u0646\u060c \u0648\u0644\u0643\u0644 \u0645\u0646\u0647\u0645\u0627 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0645\u062d\u062f\u062f\u0629.<\/p>\n<h2>\u0627\u0639\u062a\u0645\u0627\u062f FDA (\u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629)<\/h2>\n<h3>\u0645\u0627 \u0647\u064a FDA\u061f<\/h3>\n<p>\u062a\u0646\u0638\u0651\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0627\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629 \u0628\u0627\u0639\u062a\u0628\u0627\u0631\u0647\u0627 \u0623\u062c\u0647\u0632\u0629 \u0637\u0628\u064a\u0629. \u064a\u062c\u0628 \u0623\u0646 \u062a\u062d\u0635\u0644 \u062c\u0645\u064a\u0639 \u0627\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629 \u0627\u0644\u0645\u064f\u0628\u0627\u0639\u0629 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0639\u0644\u0649 \u062a\u0635\u0631\u064a\u062d FDA 510(k).<\/p>\n<h3>\u0645\u062a\u0637\u0644\u0628\u0627\u062a FDA<\/h3>\n<ul>\n<li>\u0625\u0634\u0639\u0627\u0631 \u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u062a\u0633\u0648\u064a\u0642 510(k)<\/li>\n<li>\u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0646\u0634\u0623\u0629<\/li>\n<li>\u0625\u062f\u0631\u0627\u062c \u0627\u0644\u062c\u0647\u0627\u0632<\/li>\n<li>\u0644\u0627\u0626\u062d\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629 (21 CFR Part 820)<\/li>\n<li>\u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n<\/ul>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 \u0627\u0644\u0632\u0645\u0646\u064a \u0644\u0640 FDA<\/h3>\n<p>\u0627\u0644\u062a\u0635\u0631\u064a\u062d \u0627\u0644\u0645\u0628\u062f\u0626\u064a: 3-6 \u0623\u0634\u0647\u0631 | \u0627\u0644\u062a\u062c\u062f\u064a\u062f: \u0633\u0646\u0648\u064a<\/p>\n<h2>\u0627\u0639\u062a\u0645\u0627\u062f CE (\u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a)<\/h2>\n<h3>\u0645\u0627 \u0647\u064a CE\u061f<\/h3>\n<p>\u062a\u0634\u064a\u0631 \u0639\u0644\u0627\u0645\u0629 CE \u0625\u0644\u0649 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0627\u0644\u0635\u062d\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0628\u064a\u0626\u0629. \u062a\u0646\u062f\u0631\u062c \u0627\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629 \u062a\u062d\u062a \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR).<\/p>\n<h3>\u0645\u062a\u0637\u0644\u0628\u0627\u062a CE<\/h3>\n<ul>\n<li>\u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u0642\u0646\u064a\u0629<\/li>\n<li>\u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a<\/li>\n<li>\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 (ISO 13485)<\/li>\n<li>\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u062c\u0647\u0629 \u0627\u0644\u0645\u064f\u0628\u0644\u064e\u0651\u063a\u0629<\/li>\n<li>\u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642<\/li>\n<\/ul>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 \u0627\u0644\u0632\u0645\u0646\u064a \u0644\u0640 CE<\/h3>\n<p>\u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f \u0627\u0644\u0645\u0628\u062f\u0626\u064a: 6-12 \u0623\u0634\u0647\u0631 | \u0627\u0644\u062a\u062c\u062f\u064a\u062f: \u0643\u0644 5 \u0633\u0646\u0648\u0627\u062a<\/p>\n<h2>\u0627\u0644\u0641\u0631\u0648\u0642\u0627\u062a \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629<\/h2>\n<h3>\u0645\u0642\u0627\u0631\u0646\u0629 \u0628\u064a\u0646 FDA \u0648 CE<\/h3>\n<ul>\n<li><strong>\u0627\u0644\u062a\u063a\u0637\u064a\u0629 \u0627\u0644\u0633\u0648\u0642\u064a\u0629:<\/strong> FDA = \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0641\u0642\u0637 | CE = \u0623\u0643\u062b\u0631 \u0645\u0646 30 \u062f\u0648\u0644\u0629 \u0623\u0648\u0631\u0648\u0628\u064a\u0629<\/li>\n<li><strong>\u0627\u0644\u0639\u0645\u0644\u064a\u0629:<\/strong> FDA = \u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0645\u0646\u062a\u062c | CE = \u0642\u0627\u0626\u0645\u0629 \u0639\u0644\u0649 \u0627\u0644\u0646\u0638\u0627\u0645<\/li>\n<li><strong>\u0627\u0644\u062c\u062f\u0648\u0644 \u0627\u0644\u0632\u0645\u0646\u064a:<\/strong> FDA = \u0628\u062f\u0621 \u0623\u0633\u0631\u0639 | CE = \u0623\u0637\u0648\u0644 \u0644\u0643\u0646 \u0623\u0648\u0633\u0639 \u0646\u0637\u0627\u0642\u064b\u0627<\/li>\n<li><strong>\u0627\u0644\u062a\u0643\u0644\u0641\u0629:<\/strong> FDA = $3,000-15,000 | CE = \u20ac15,000-50,000+<\/li>\n<\/ul>\n<h2>\u0623\u064a\u0647\u0645\u0627 \u062a\u062d\u062a\u0627\u062c\u061f<\/h2>\n<h3>\u0627\u062e\u062a\u0631 FDA \u0625\u0630\u0627:<\/h3>\n<ul>\n<li>\u0643\u0646\u062a \u062a\u0633\u062a\u0647\u062f\u0641 \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0628\u0634\u0643\u0644 \u0623\u0633\u0627\u0633\u064a<\/li>\n<li>\u0643\u0646\u062a \u062a\u0631\u063a\u0628 \u0641\u064a \u062a\u0635\u0631\u064a\u062d \u0645\u0628\u062f\u0626\u064a \u0623\u0633\u0631\u0639<\/li>\n<li>\u0643\u0627\u0646\u062a \u0644\u062f\u064a\u0643 \u0645\u064a\u0632\u0627\u0646\u064a\u0629 \u0645\u062d\u062f\u0648\u062f\u0629 \u0644\u0644\u0627\u0639\u062a\u0645\u0627\u062f<\/li>\n<\/ul>\n<h3>\u0627\u062e\u062a\u0631 CE \u0625\u0630\u0627:<\/h3>\n<ul>\n<li>\u0643\u0646\u062a \u062a\u0633\u062a\u0647\u062f\u0641 \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629<\/li>\n<li>\u0643\u0646\u062a \u062a\u0631\u063a\u0628 \u0641\u064a \u062a\u063a\u0637\u064a\u0629 \u062c\u063a\u0631\u0627\u0641\u064a\u0629 \u0623\u0648\u0633\u0639<\/li>\n<li>\u0643\u0646\u062a \u062a\u062e\u0637\u0637 \u0644\u062a\u0648\u0633\u0639 \u062f\u0648\u0644\u064a \u0637\u0648\u064a\u0644 \u0627\u0644\u0623\u0645\u062f<\/li>\n<\/ul>\n<h3>\u0627\u0644\u0633\u064a\u0646\u0627\u0631\u064a\u0648 \u0627\u0644\u0645\u062b\u0627\u0644\u064a<\/h3>\n<p>\u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0639\u062a\u0645\u0627\u062f\u064e\u064a FDA \u0648 CE \u0645\u0639\u064b\u0627. \u064a\u0645\u0646\u062d\u0643 \u0630\u0644\u0643 \u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u0648\u0635\u0648\u0644 \u0625\u0644\u0649 \u0623\u0643\u0628\u0631 \u0633\u0648\u0642\u064a\u0646 \u0644\u0644\u0639\u062f\u0633\u0627\u062a \u0627\u0644\u0644\u0627\u0635\u0642\u0629 \u0648\u064a\u064f\u0638\u0647\u0631 \u0627\u0644\u062a\u0632\u0627\u0645\u0643 \u0628\u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629.<\/p>\n<h2>\u0641\u064a MIOMI Optical<\/h2>\n<p>\u0646\u062d\u0627\u0641\u0638 \u0639\u0644\u0649 \u0627\u0639\u062a\u0645\u0627\u062f\u064e\u064a FDA \u0648 CE \u0645\u0639\u064b\u0627:<\/p>\n<ul>\n<li>\u0645\u0646\u0634\u0623\u0629 \u0645\u0633\u062c\u0644\u0629 \u0644\u062f\u0649 FDA<\/li>\n<li>\u0645\u0646\u062a\u062c\u0627\u062a \u062a\u062d\u0645\u0644 \u0639\u0644\u0627\u0645\u0629 CE (\u0645\u062a\u0648\u0627\u0641\u0642\u0629 \u0645\u0639 MDR)<\/li>\n<li>\u0646\u0638\u0627\u0645 \u062c\u0648\u062f\u0629 \u0645\u0639\u062a\u0645\u062f \u0648\u0641\u0642 ISO 13485<\/li>\n<li>\u062f\u0639\u0645 \u062a\u0648\u062b\u064a\u0642\u064a \u0643\u0627\u0645\u0644 \u0644\u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0639\u0644\u0627\u0645\u0629 \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629<\/li>\n<\/ul>\n<p>\u062a\u0648\u0627\u0635\u0644 \u0645\u0639\u0646\u0627: eye@miomi.cc | miomicon.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u064a\u064f\u0639\u062f\u0651 \u0641\u0647\u0645 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f \u0623\u0645\u0631\u064b\u0627 \u0628\u0627\u0644\u063a \u0627\u0644\u0623\u0647\u0645\u064a\u0629 \u0644\u0623\u0635\u062d\u0627\u0628 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":16190,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_yoast_wpseo_title":"","_yoast_wpseo_metadesc":"","_yoast_wpseo_focuskw":"","rank_math_title":"","rank_math_description":"","rank_math_focus_keyword":"","_aioseop_title":"","_aioseop_description":""},"categories":[182],"tags":[],"class_list":["post-16189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-182"],"_links":{"self":[{"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/posts\/16189","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/comments?post=16189"}],"version-history":[{"count":0,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/posts\/16189\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/media\/16190"}],"wp:attachment":[{"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/media?parent=16189"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/categories?post=16189"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/miomicon.com\/ar\/wp-json\/wp\/v2\/tags?post=16189"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}