{"id":3274,"date":"2025-10-01T02:14:52","date_gmt":"2025-10-01T02:14:52","guid":{"rendered":"https:\/\/hanheng.easiwin.com\/?p=3274"},"modified":"2025-04-11T02:33:59","modified_gmt":"2025-04-11T02:33:59","slug":"medical-swabs20250729","status":"publish","type":"post","link":"https:\/\/hanheng-medical.com\/ko\/blog\/medical-swabs20250729\/","title":{"rendered":"EU\ub85c\uc758 \uc758\ub8cc \uc2a4\uc640\ube0c \uc218\uc785 \uaddc\uc815 \ud0d0\uc0c9 (2025)"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"1-introduction-why-understanding-eu-import-regulations-for-medical-swabs-matters-in-2025\">1. \uc11c\ub860: 2025\ub144 EU \uc758\ub8cc \uc2a4\uc640\ube0c \uc218\uc785 \uaddc\uc815 \uc774\ud574\uc758 \uc911\uc694\uc131<\/h2>\n\n\n\n<p>\uc720\ub7fd\uc5f0\ud569\uc774 \uc758\ub8cc \uae30\uae30\uc640 \uc9c4\ub2e8 \uc18c\ubaa8\ud488\uc5d0 \ub300\ud55c \uaddc\uc81c \uc694\uac74\uc744 \uac15\ud654\ud568\uc5d0 \ub530\ub77c, \uc758\ub8cc \uc2a4\uc640\ube0c \uc218\uc785 \uaddc\uc815\uc744 \ud0d0\uc0c9\ud558\ub294 \uc77c\uc774 B2B \uad6c\ub9e4\uc790, \uc720\ud1b5\uc5c5\uc790 \ubc0f \uc870\ub2ec \uad00\ub9ac\uc790\uc5d0\uac8c \uc911\uc694\ud55c \uc6b0\uc120 \uacfc\uc81c\uac00 \ub418\uc5c8\uc2b5\ub2c8\ub2e4. 2025\ub144\uc5d0\ub294 \uc900\uc218\uac00 \uc120\ud0dd \uc0ac\ud56d\uc774 \ub354 \uc774\uc0c1 \uc544\ub2c8\uba70 \u2013 EU \ud68c\uc6d0\uad6d \uac04 \uc0ac\uc5c5 \uc218\ud589\uc758 \ud544\uc218 \uc694\uc18c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc758\ub8cc \uc2a4\uc640\ube0c, \ud2b9\ud788 \uc9c4\ub2e8 \uac80\uc0ac\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uac83(\uc608: \ube44\uc778\ub450, \uad6c\uc778\ub450 \ubc0f \uc790\uad81\uacbd\ubd80 \uc0d8\ud50c\ub9c1\uc6a9)\uc740 EU \uc758\ub8cc \uae30\uae30 \uaddc\uc815(MDR 2017\/745)\uc5d0 \ub530\ub77c \uc758\ub8cc \uae30\uae30\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4. \ub3c4\ub9e4\uc0c1, \uc2e4\ud5d8\uc2e4 \uacf5\uae09\uc5c5\uc790 \ub610\ub294 \ubcd1\uc6d0 \uc870\ub2ec \ub2f4\ub2f9\uc790\uc774\ub4e0, \uc218\uc785 \uc81c\ud488\uc774 EU \ud45c\uc900\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud558\ub294 \uac83\uc740 \uc2dc\uc7a5 \uc811\uadfc\uacfc \ubc95\uc801 \uc6b4\uc601\uc5d0 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"importance-of-regulatory-alignment-for-b2b-buyers\">B2B \uad6c\ub9e4\uc790\ub97c \uc704\ud55c \uaddc\uc81c \uc77c\uce58\uc758 \uc911\uc694\uc131<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uacf5\uae09\ub9dd \uc911\ub2e8 \ubc29\uc9c0 \ubc0f \uad00\uc138 \ud1b5\uad00 \ubcf4\uc7a5<\/li>\n\n\n\n<li>\ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc9c0\uc5f0, \ubc8c\uae08 \ub610\ub294 \uc81c\ud488 \ud68c\uc218 \ubc29\uc9c0<\/li>\n\n\n\n<li>\uc758\ub8cc \uc81c\uacf5\uc790 \ubc0f \uae30\uad00 \uad6c\ub9e4\uc790\uc640\uc758 \uc2e0\ub8b0 \uad6c\ucd95<\/li>\n\n\n\n<li>EU \ub0b4 \ube0c\ub79c\ub4dc \uc2e0\ub8b0\uc131 \ubc0f \uc0ac\uc5c5 \uc9c0\uc18d\uc131 \uac15\ud654<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"regulatory-priorities-for-2025\">2025\ub144 \uaddc\uc81c \uc6b0\uc120 \uacfc\uc81c<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc8fc\uc694 \uc601\uc5ed<\/th><th>\uc124\uba85<\/th><\/tr><\/thead><tbody><tr><td>MDR \uc900\uc218<\/td><td>\uc2a4\uc640\ube0c\ub97c \ud3ec\ud568\ud55c \ubaa8\ub4e0 \ud074\ub798\uc2a4 I-III \uc758\ub8cc \uae30\uae30\ub294 MDR 2017\/745\ub97c \uc900\uc218\ud574\uc57c \ud568<\/td><\/tr><tr><td>CE \ub9c8\ud06c<\/td><td>EU \uc2dc\uc7a5 \uc811\uadfc\uc5d0 \ud544\uc218 \u2013 \uc801\ud569\uc131 \ud3c9\uac00 \uc99d\uba85<\/td><\/tr><tr><td>UDI (\uace0\uc720 \uae30\uae30 \uc2dd\ubcc4)<\/td><td>\ucd94\uc801 \uac00\ub2a5\uc131 \ubc0f \uc2dc\uc7a5 \ud6c4 \uac10\uc2dc\ub97c \uc704\ud574 \uc694\uad6c\ub428<\/td><\/tr><tr><td>EU \uacf5\uc778 \ub300\ub9ac\uc778<\/td><td>\ube44EU \uc81c\uc870\uc0ac\ub294 \uaddc\uc81c \ucee4\ubba4\ub2c8\ucf00\uc774\uc158\uc744 \uc704\ud574 \uc9c0\uc815\ud574\uc57c \ud568<\/td><\/tr><tr><td>\uc218\uc785\uc790 \uc758\ubb34<\/td><td>\uc218\uc785\uc790\ub294 \ubb38\uc11c \ubc0f \uc81c\ud488 \uc801\ud569\uc131\uc744 \uac80\uc99d\ud574\uc57c \ud568<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>EU \uaddc\uc81c \ud658\uacbd\uc758 \uc774\ub7ec\ud55c \ud544\uc218 \uad6c\uc131 \uc694\uc18c\ub97c \uc774\ud574\ud558\ub294 \uac83\uc774 2025\ub144 \uc900\uc218\ub418\uace0 \uc218\uc775\uc131 \uc788\ub294 \uc758\ub8cc \uc2a4\uc640\ube0c \uacf5\uae09\ub9dd \uad6c\ucd95\uc758 \uccab \ubc88\uc9f8 \ub2e8\uacc4\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"2-the-current-eu-market-landscape-for-medical-swabs-and-diagnostic-consumables\">2. \uc758\ub8cc \uc2a4\uc640\ube0c \ubc0f \uc9c4\ub2e8 \uc18c\ubaa8\ud488\uc5d0 \ub300\ud55c \ud604\uc7ac EU \uc2dc\uc7a5 \ud604\ud669<\/h2>\n\n\n\n<p>\uc720\ub7fd\uc5f0\ud569\uc758 \uc758\ub8cc \uc2a4\uc640\ube0c \uc2dc\uc7a5\uc740 \uac10\uc5fc\ubcd1 \uac80\uc0ac\uc5d0 \ub300\ud55c \uc218\uc694 \uc99d\uac00\ub85c \uc778\ud574 \uc0c1\ub2f9\ud55c \uc131\uc7a5\uc744 \uacbd\ud5d8\ud588\uc2b5\ub2c8\ub2e4. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Cervical_cancer\" target=\"_blank\" rel=\"noopener\">\uc790\uad81\uacbd\ubd80\uc554<\/a> \uc2a4\ud06c\ub9ac\ub2dd \ubc0f \uc77c\uc0c1 \uc9c4\ub2e8. COVID-19 \uc774\ud6c4, \uc9c4\ub2e8 \uac80\uc0ac\uc5d0 \ub300\ud55c \uc778\uc2dd\uacfc \uc778\ud504\ub77c\uac00 \uacac\uace0\ud558\uac8c \uc720\uc9c0\ub418\uc5b4 \uace0\ud488\uc9c8 \uc2a4\uc640\ube0c \ubc0f \uad00\ub828 \uc18c\ubaa8\ud488\uc5d0 \ub300\ud55c \uc9c0\uc18d\uc801\uc778 \uc218\uc694\ub97c \ucc3d\ucd9c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"market-overview-and-growth-factors\">\uc2dc\uc7a5 \uac1c\uc694 \ubc0f \uc131\uc7a5 \uc694\uc778<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\ud329\ud130<\/th><th>\uc2a4\uc640\ube0c \uc218\uc694\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5<\/th><\/tr><\/thead><tbody><tr><td>\uc77c\uc0c1\uc801\uc778 COVID-19 \ubaa8\ub2c8\ud130\ub9c1<\/td><td>\ube44\uac15 \ubc0f \uc778\ub450 \uc2a4\uc640\ube0c \uc218\uc694 \uc720\uc9c0<\/td><\/tr><tr><td>HPV \ubc0f \uc790\uad81\uacbd\ubd80\uc554 \uc2a4\ud06c\ub9ac\ub2dd<\/td><td>\uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc \ubc0f \uc2a4\ud06c\ub808\uc774\ud37c \uc0ac\uc6a9 \uc99d\uac00<\/td><\/tr><tr><td>\ud604\uc7a5 \uac80\uc0ac \ud655\ub300<\/td><td>\uace0\ud488\uc9c8, \uba78\uade0 \uc0d8\ud50c\ub9c1 \ub3c4\uad6c \uc694\uad6c<\/td><\/tr><tr><td>EU \uc758\ub8cc \ub514\uc9c0\ud138\ud654<\/td><td>\ucd94\uc801 \uac00\ub2a5\ud558\uace0 CE \ub9c8\ud0b9\ub41c \uc758\ub8cc \uae30\uae30 \uc120\ud638<\/td><\/tr><tr><td>\uace0\ub839\ud654 \uc778\uad6c<\/td><td>\uc9c4\ub2e8 \ubc0f \uc608\ubc29 \uac80\uc0ac \uc218\uc694 \ucd09\uc9c4<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"opportunities-for-b2b-buyers-and-distributors\">B2B \ubc14\uc774\uc5b4 \ubc0f \uc720\ud1b5\uc5c5\uccb4\ub97c \uc704\ud55c \uae30\ud68c<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uacf5\uae09 \ud30c\ud2b8\ub108\ub97c \ucc3e\ub294 \ubcd1\uc6d0 \ubc0f \uc9c4\ub2e8 \uc5f0\uad6c\uc18c<\/li>\n\n\n\n<li>\uc870\ub2ec \ud604\uc9c0\ud654\ub97c \ucd94\uad6c\ud558\ub294 \uad6d\uac00 \ubcf4\uac74 \uc11c\ube44\uc2a4<\/li>\n\n\n\n<li>\uaddc\uc81c \uc81c\ud488\uc73c\ub85c \ud655\uc7a5\ud558\ub294 \uc804\uc790\uc0c1\uac70\ub798 \uc758\ub8cc \ud50c\ub7ab\ud3fc<\/li>\n\n\n\n<li>\uacc4\uc57d \uc5f0\uad6c \uae30\uad00(CRO) \ubc0f \uc784\uc0c1 \uc2dc\ud5d8 \uacf5\uae09\uc5c5\uc790<\/li>\n<\/ul>\n\n\n\n<p>\uaddc\uc81c \ubc0f \ud488\uc9c8 \uae30\ub300\uc5d0 \ubd80\ud569\ud558\ub294 B2B \uc720\ud1b5\uc5c5\uc790 \ubc0f \uc804\uc790\uc0c1\uac70\ub798 \ud310\ub9e4\uc790\ub294 \uc801\uc808\ud55c \uc870\ub2ec \uc804\ub7b5\uc73c\ub85c \uc218\uc775\uc131 \uc788\ub294 EU \uc758\ub8cc \ubd80\ubb38\uc5d0 \uc9c4\uc785\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"high-demand-swab-types-in-the-eu\">EU \ub0b4 \uace0\uc218\uc694 \uc2a4\uc640\ube0c \uc720\ud615<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uba74\ubd09 \uc720\ud615<\/th><th>\uc6a9\ub3c4<\/th><th>\uaddc\uc81c \ud074\ub798\uc2a4<\/th><\/tr><\/thead><tbody><tr><td>\ube44\uc778\ub450 \uba74\ubd09<\/td><td>\ud638\ud761\uae30 \ubc14\uc774\ub7ec\uc2a4 \uac80\ucd9c<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><tr><td>\uad6c\uc778\ub450 \uba74\ubd09<\/td><td>COVID-19, \ub3c5\uac10 \uac80\uc0ac<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><tr><td>\uc790\uad81 \uacbd\ubd80 \uc0d8\ud50c\ub9c1 \ube0c\ub7ec\uc2dc<\/td><td>HPV \uc120\ubcc4 \uac80\uc0ac, \ud30c\ud30c\ub2c8\ucf5c\ub85c \uac80\uc0ac<\/td><td>\ud074\ub798\uc2a4 IIa<\/td><\/tr><tr><td>\ubd80\uc778\uacfc \uc2a4\ud06c\ub808\uc774\ud37c<\/td><td>\uc138\ud3ec\ud559 \ubc0f \uc0d8\ud50c \uc218\uc9d1<\/td><td>\ud074\ub798\uc2a4 IIa<\/td><\/tr><tr><td>\ud50c\ub85d \uba74\ubd09<\/td><td>\uc2e0\uc18d \ud56d\uc6d0\/\ud56d\uccb4 \uac80\uc0ac<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\uc758\ub8cc\uc6a9 \uba74\ubd09\uc740 \uc774\uc81c \uc720\ub7fd \uc9c4\ub2e8 \uc6cc\ud06c\ud50c\ub85c\uc6b0\uc5d0\uc11c \ud544\uc218 \ub3c4\uad6c\uac00 \ub418\uc5c8\uc73c\uba70, MDR\uc5d0 \ub530\ub978 \ubd84\ub958\ub97c \uc774\ud574\ud558\uba74 \uacf5\uae09\uc5c5\uccb4\uac00 \uc801\ud569\ud55c \uc0b0\uc5c5 \ubd84\uc57c\ub97c \ud0c0\uac9f\ud305\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2913\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01.jpg\" alt=\"\" class=\"wp-image-2913\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2940\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2.jpg\" alt=\"\" class=\"wp-image-2940\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2936\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2.jpg\" alt=\"\" class=\"wp-image-2936\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"3-key-eu-regulatory-frameworks-mdr-ce-marking-and-customs-compliance\">3. \uc8fc\uc694 EU \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c: MDR, CE \ub9c8\ud0b9 \ubc0f \uad00\uc138 \uc900\uc218<\/h2>\n\n\n\n<p>EU \uc758\ub8cc\uae30\uae30 \uaddc\uc815(MDR 2017\/745)\uc740 2021\ub144 5\uc6d4\uc5d0 \uc774\uc804 MDD\ub97c \uc644\uc804\ud788 \ub300\uccb4\ud588\uc73c\uba70, \uc774\uc81c EU \ub0b4 \uc758\ub8cc\uc6a9 \uba74\ubd09\uc758 \uc218\uc785 \ubc0f \uc720\ud1b5\uc744 \uaddc\uc81c\ud558\ub294 \uc911\uc559 \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"medical-device-regulation-mdr-2017-745\">\uc758\ub8cc\uae30\uae30 \uaddc\uc815 (MDR 2017\/745)<\/h3>\n\n\n\n<p>MDR\uc740 \uc758\ub8cc\uc6a9 \uba74\ubd09\uc744 \uc758\ub3c4\ub41c \uc6a9\ub3c4\uc5d0 \ub530\ub77c \uc758\ub8cc\uae30\uae30\ub85c \ubd84\ub958\ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc77c\ubc18 \uc6a9\ub3c4 \uba74\ubd09\uc740 \uba74\uc81c\ub420 \uc218 \uc788\uc74c<\/li>\n\n\n\n<li>\uc9c4\ub2e8\uc6a9 \uba74\ubd09(\ube44\uac15, \uc790\uad81\uacbd\ubd80)\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ud074\ub798\uc2a4 I \ub610\ub294 IIa<\/li>\n\n\n\n<li>\uc790\uac00 \ucc44\ucde8\uc6a9 \uba74\ubd09\uc740 \ucd94\uac00 \uc694\uad6c\uc0ac\ud56d\uc774 \uc788\uc744 \uc218 \uc788\uc74c<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"key-mdr-requirements-for-medical-swabs\">\uc758\ub8cc\uc6a9 \uba74\ubd09\uc5d0 \ub300\ud55c \uc8fc\uc694 MDR \uc694\uad6c\uc0ac\ud56d<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc704\ud5d8 \ubd84\ub958 (\ud074\ub798\uc2a4 I, IIa)<\/li>\n\n\n\n<li>\uc784\uc0c1 \ud3c9\uac00 \ubc0f \uae30\uc220 \ubb38\uc11c<\/li>\n\n\n\n<li>\uc2dc\ud310 \ud6c4 \uac10\uc2dc \uacc4\ud68d<\/li>\n\n\n\n<li>\uace0\uc720 \uc7a5\uce58 \uc2dd\ubcc4(UDI)<\/li>\n\n\n\n<li>CE \ub9c8\ud0b9 \ubc0f \uc801\ud569\uc131 \uc120\uc5b8<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"ce-marking-for-medical-swabs\">\uc758\ub8cc\uc6a9 \uba74\ubd09\uc5d0 \ub300\ud55c CE \ub9c8\ud0b9<\/h3>\n\n\n\n<p>CE \ub9c8\ud06c\ub294 \uc720\ub7fd \uacbd\uc81c \uc601\uc5ed(EEA) \ub0b4\uc5d0\uc11c \ud310\ub9e4\ub418\ub294 \uc81c\ud488\uc5d0 \ub300\ud55c \ud544\uc218 \uc801\ud569\uc131 \ub9c8\ud0b9\uc785\ub2c8\ub2e4. \uc758\ub8cc\uc6a9 \uba74\ubd09\uc758 \uacbd\uc6b0, \uc774\ub294 \uc81c\ud488\uc774 \ud544\uc218 \uc548\uc804 \ubc0f \uc131\ub2a5 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud568\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"steps-to-obtain-ce-marking\">CE \ub9c8\ud0b9 \ud68d\ub4dd \ub2e8\uacc4<\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\uba74\ubd09\uc758 \uc62c\ubc14\ub978 \ubd84\ub958 \uacb0\uc815<\/li>\n\n\n\n<li>\uc704\ud5d8 \ud3c9\uac00 \ubc0f \ud14c\uc2a4\ud2b8 \ubcf4\uace0\uc11c\ub97c \ud3ec\ud568\ud55c \uae30\uc220 \ud30c\uc77c \uc791\uc131<\/li>\n\n\n\n<li>\uc784\uc0c1 \ud3c9\uac00 \uc2e4\uc2dc (\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0)<\/li>\n\n\n\n<li>EU \uacf5\uc778 \ub300\ub9ac\uc778 \uc9c0\uc815 (\uc81c\uc870\uc0ac\uac00 EU \uc678\ubd80\uc778 \uacbd\uc6b0)<\/li>\n\n\n\n<li>\uc801\ud569\uc131 \ud3c9\uac00 \ubc1b\uae30 (\ud074\ub798\uc2a4 I\uc758 \uacbd\uc6b0 \uc790\uccb4 \uc778\uc99d, IIa\uc758 \uacbd\uc6b0 \ud1b5\uc9c0 \uae30\uad00)<\/li>\n\n\n\n<li>\uc81c\ud488\uc744 EUDAMED(EU \uc758\ub8cc\uae30\uae30 \ub370\uc774\ud130\ubca0\uc774\uc2a4)\uc5d0 \ub4f1\ub85d<\/li>\n\n\n\n<li>\ud3ec\uc7a5 \ubc0f \ubb38\uc11c\uc5d0 CE \ub9c8\ud06c\ub97c \uba85\ud655\ud788 \ubd80\ucc29<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"customs-and-import-compliance\">\uc138\uad00 \ubc0f \uc218\uc785 \uc900\uc218<\/h3>\n\n\n\n<p>MDR \ud2b9\uc815 \uc694\uad6c\uc0ac\ud56d \uc678\uc5d0, \uc218\uc785\uc5c5\uc790\ub294 \ub2e4\uc74c\uc744 \ud3ec\ud568\ud55c EU \uc138\uad00 \uc808\ucc28\ub97c \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc62c\ubc14\ub978 \uc138\uad00 \ubd84\ub958\ub97c \uc704\ud55c TARIC \ucf54\ub4dc<\/li>\n\n\n\n<li>\uad6d\uacbd\uc5d0\uc11c\uc758 CE \uc900\uc218 \uc99d\uba85<\/li>\n\n\n\n<li>\uc218\uc785 \ubd80\uac00\uac00\uce58\uc138 \ubc0f \uad00\uc138 \uc2e0\uace0<\/li>\n\n\n\n<li>EU \uacbd\uc81c \uc6b4\uc601\uc790 \ub4f1\ub85d \ubc0f \uc2dd\ubcc4(EORI) \ubc88\ud638<\/li>\n\n\n\n<li>\uc138\uad00 \ubc0f \ubcf4\uac74 \ub2f9\uad6d\uacfc\uc758 \ubb38\uc11c \uc870\ud654<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc900\uc218 \uc694\uc18c<\/th><th>\ud544\uc218 \uc0ac\ud56d<\/th><th>\ucc45\uc784\uc790<\/th><\/tr><\/thead><tbody><tr><td>CE \ub9c8\ud06c<\/td><td>EU \ub0b4 \ud569\ubc95\uc801 \ud310\ub9e4<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>EORI \ubc88\ud638<\/td><td>\ud1b5\uad00 \uc808\ucc28<\/td><td>\uc218\uc785\uc5c5\uc790<\/td><\/tr><tr><td>\uae30\uc220 \ud30c\uc77c<\/td><td>\uc2dc\uc7a5 \uac10\uc2dc<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>\uacf5\uc778 \ub300\ub9ac\uc778<\/td><td>\uaddc\uc81c \ucee4\ubba4\ub2c8\ucf00\uc774\uc158<\/td><td>EU \uc678 \uc81c\uc870\uc0ac<\/td><\/tr><tr><td>EU \uc5b8\uc5b4\ub85c \ub77c\ubca8\ub9c1<\/td><td>\uc81c\ud488 \ud3ec\uc7a5<\/td><td>\uc81c\uc870\uc0ac\/\uc218\uc785\uc5c5\uc790<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\uc774\ub7ec\ud55c \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uc9c0 \ubabb\ud558\uba74 \uc138\uad00 \uac70\ubd80, \ubc8c\uae08 \ub610\ub294 \uc81c\ud488 \uc555\ub958\uac00 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc73c\uba70, \uc774\ub294 \ubaa8\ub4e0 EU\ud589 \uc120\uc801\uc5d0 \ucca0\uc800\ud55c \uaddc\uc81c \uc815\ub82c\uc744 \ud544\uc218\ub85c \ub9cc\ub4ed\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"zKUIMtmxXQ\"><a href=\"https:\/\/hanheng-medical.com\/ko\/product\/polyurethane-foam-swab-equipement-and-electronic-devices-maintenance-cleaning-longer-and-thicker-plastic-shaft-g-070\/\">\ud3f4\ub9ac\uc6b0\ub808\ud0c4 \ud3fc \uba74\ubd09\/\uc7a5\ube44 \ubc0f \uc804\uc790 \uae30\uae30 \uc720\uc9c0 \ubcf4\uc218 \uccad\uc18c\/\ub354 \uae38\uace0 \ub450\uaebc\uc6b4 \ud50c\ub77c\uc2a4\ud2f1 \uc0e4\ud504\ud2b8 G-070<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&quot;\ud3f4\ub9ac\uc6b0\ub808\ud0c4 \ud3fc \uba74\ubd09\/\uc7a5\ube44 \ubc0f \uc804\uc790 \uc7a5\uce58 \uc720\uc9c0 \ubcf4\uc218 \uccad\uc18c\/\ub354 \uae38\uace0 \ub450\uaebc\uc6b4 \ud50c\ub77c\uc2a4\ud2f1 \uc0e4\ud504\ud2b8 G-070&quot; \u2014 Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/polyurethane-foam-swab-equipement-and-electronic-devices-maintenance-cleaning-longer-and-thicker-plastic-shaft-g-070\/embed\/#?secret=vaFkSGQ2zO#?secret=zKUIMtmxXQ\" data-secret=\"zKUIMtmxXQ\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"4-top-considerations-when-sourcing-medical-swabs-for-eu-distribution\">4. EU \uc720\ud1b5\uc744 \uc704\ud55c \uc758\ub8cc \uc2a4\uc640\ube0c \uc870\ub2ec \uc2dc \uc8fc\uc694 \uace0\ub824 \uc0ac\ud56d<\/h2>\n\n\n\n<p>\uc758\ub8cc\uc6a9 \uba74\ubd09\uc758 \uc801\ud569\ud55c \uacf5\uae09\uc5c5\uccb4\ub97c \uc120\ud0dd\ud558\ub294 \uac83\uc740 \uacbd\uc7c1\ub825 \uc788\ub294 \uac00\uaca9\uc744 \ucc3e\ub294 \uac83 \uc774\uc0c1\uc785\ub2c8\ub2e4\u2014\uc774\ub294 \uc644\uc804\ud55c \uaddc\uc81c \uc900\uc218, \uc77c\uad00\ub41c \uc81c\ud488 \ud488\uc9c8 \ubc0f \uc7a5\uae30\uc801 \uc2e0\ub8b0\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uace0\ub824\uc0ac\ud56d\uc740 MDR \ubc0f CE \ub9c8\ud0b9 \uc900\uc218\uac00 \uc5c4\uaca9\ud788 \uc2dc\ud589\ub418\ub294 EU\ub85c \uc218\uc785\ud560 \uc900\ube44\ub97c \ud560 \ub54c \ud2b9\ud788 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-factors-eu-distributors-and-buyers-must-evaluate\">EU \uc720\ud1b5\uc5c5\uc790 \ubc0f \uad6c\ub9e4\uc790\uac00 \ud3c9\uac00\ud574\uc57c \ud560 \uc8fc\uc694 \uc694\uc778<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uace0\ub824 \uc0ac\ud56d<\/th><th>\uc911\uc694\uc131<\/th><th>\uc601\ud5a5<\/th><\/tr><\/thead><tbody><tr><td>MDR \ubc0f CE \uc900\uc218<\/td><td>\ud544\uc218<\/td><td>\ud569\ubc95\uc801\uc778 EU \uc2dc\uc7a5 \uc811\uadfc \ubcf4\uc7a5<\/td><\/tr><tr><td>\uc81c\ud488 \ud488\uc9c8 \ubc0f \ubb34\uade0\uc131<\/td><td>\ub192\uc74c<\/td><td>\uc9c4\ub2e8 \uc815\ud655\ub3c4\uc5d0 \uc601\ud5a5<\/td><\/tr><tr><td>\ud074\ub9b0\ub8f8 \uc81c\uc870<\/td><td>\ud544\uc218<\/td><td>\uc624\uc5fc \ubc29\uc9c0<\/td><\/tr><tr><td>\uc778\uc99d(ISO, FDA, CE)<\/td><td>\ub192\uc74c<\/td><td>\uc804 \uc138\uacc4\uc801 \uc2e0\ub8b0 \uac80\uc99d<\/td><\/tr><tr><td>\ubb38\uc11c \uc900\ube44 \uc0c1\ud0dc<\/td><td>\ub192\uc74c<\/td><td>\ud1b5\uad00 \uc808\ucc28 \uac04\uc18c\ud654<\/td><\/tr><tr><td>\uacf5\uae09 \ud655\ub300 \uac00\ub2a5\uc131<\/td><td>\uc911\uac04<\/td><td>\uc218\uc694 \uc99d\uac00 \uc9c0\uc6d0<\/td><\/tr><tr><td>\uc81c\ud488 \ub2e4\uc591\uc131<\/td><td>\uc911\uac04<\/td><td>\uce74\ud0c8\ub85c\uadf8 \ud655\ub300 \uac00\ub2a5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"product-quality-and-sterility-standards\">\uc81c\ud488 \ud488\uc9c8 \ubc0f \uba78\uade0 \uae30\uc900<\/h3>\n\n\n\n<p>\uc9c4\ub2e8 \uc6a9\ub3c4\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc758\ub8cc\uc6a9 \uc2a4\uc651\uc740 \uad50\ucc28 \uc624\uc5fc\uc774\ub098 \uacb0\uacfc \uc65c\uace1\uc744 \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \ud1b5\uc81c\ub41c \ud658\uacbd\uc5d0\uc11c \uc81c\uc870\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub2e4\uc74c\uc744 \ucc3e\uc73c\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud074\ub798\uc2a4 100,000 (ISO 8) \ud074\ub9b0\ub8f8 \uc778\uc99d<\/li>\n\n\n\n<li>EO \uba78\uade0 \ubc29\ubc95<\/li>\n\n\n\n<li>\uc720\ud6a8 \uae30\uac04 \uac80\uc99d \uc5f0\uad6c<\/li>\n\n\n\n<li>\uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \uc138\ud3ec \ub3c5\uc131 \ud14c\uc2a4\ud2b8<\/li>\n\n\n\n<li>\ub85c\ud2b8 \ucd94\uc801 \ubc0f \ubc30\uce58 \uad00\ub9ac<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"supplier-documentation-package-for-eu-import\">EU \uc218\uc785\uc744 \uc704\ud55c \uacf5\uae09\uc790 \ubb38\uc11c \ud328\ud0a4\uc9c0<\/h3>\n\n\n\n<p>\ubaa8\ub4e0 \uc120\uc801\uc5d0\ub294 MDR \ubc0f \ud1b5\uad00 \uc900\uc218\ub97c \ucda9\uc871\ud558\ub294 \ubb38\uc11c \ubc88\ub4e4\uc774 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc801\ud569\uc131 \uc120\uc5b8(DoC)<\/li>\n\n\n\n<li>CE \uc778\uc99d\uc11c (\ud074\ub798\uc2a4 IIa \uc774\uc0c1\uc778 \uacbd\uc6b0)<\/li>\n\n\n\n<li>ISO13485 \uc778\uc99d\uc11c<\/li>\n\n\n\n<li>\uba78\uade0 \ubcf4\uace0\uc11c<\/li>\n\n\n\n<li>EU \uc5b8\uc5b4\ub85c \ub41c \uc0ac\uc6a9 \uc9c0\uce68 (IFU)<\/li>\n\n\n\n<li>\uae30\uc220 \ubb38\uc11c (\ub2f9\uad6d \uc694\uccad \uc2dc)<\/li>\n\n\n\n<li>UDI (\uace0\uc720 \uc7a5\uce58 \uc2dd\ubcc4\uc790)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"questions-to-ask-your-supplier\">\uacf5\uae09\uc5c5\uccb4\uc5d0 \ubb38\uc758\ud560 \uc9c8\ubb38<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745\ub97c \ucda9\uc871\ud558\ub294 CE \ub9c8\ud06c\uac00 \ubd80\ucc29\ub41c \uc2a4\uc651\uc744 \ubcf4\uc720\ud558\uace0 \uacc4\uc2ed\ub2c8\uae4c?<\/li>\n\n\n\n<li>\ud1b5\uad00\uc744 \uc704\ud55c \uc644\uc804\ud55c \uae30\uc220 \ubb38\uc11c\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/li>\n\n\n\n<li>\uc5b4\ub5a4 \uba78\uade0 \uacf5\uc815\uc744 \uc0ac\uc6a9\ud558\uc2ed\ub2c8\uae4c?<\/li>\n\n\n\n<li>\uc2dc\uc124\uc774 ISO13485 \uc778\uc99d\uc744 \ubc1b\uc558\uc2b5\ub2c8\uae4c?<\/li>\n\n\n\n<li>EU \uc2dc\uc7a5\uc744 \uc704\ud55c \uc0ac\uc124 \ub77c\ubca8\ub9c1 \ub610\ub294 OEM\uc744 \uc9c0\uc6d0\ud558\uc2ed\ub2c8\uae4c?<\/li>\n<\/ul>\n\n\n\n<p>\uc774\ub7ec\ud55c \ub9e4\uac1c\ubcc0\uc218\ub85c \uacf5\uae09\uc790\ub97c \ud3c9\uac00\ud568\uc73c\ub85c\uc368 EU \uc720\ud1b5\uc5c5\uccb4\uc640 B2B \uad6c\ub9e4\uc790\ub294 \uaddc\uc81c \uc704\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\uace0 \ub354 \ud0c4\ub825\uc801\uc778 \uacf5\uae09\ub9dd\uc744 \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"5-trusted-global-medical-swab-manufacturers-why-hanheng-leads-from-china\">5. \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uae00\ub85c\ubc8c \uc758\ub8cc\uc6a9 \uc2a4\uc651 \uc81c\uc870\uc5c5\uccb4 \u2013 \uc911\uad6d\uc758 Hanheng\uc774 \uc120\ub3c4\ud558\ub294 \uc774\uc720<\/h2>\n\n\n\n<p>\ub9ce\uc740 \uae00\ub85c\ubc8c \uc81c\uc870\uc5c5\uccb4\uac00 \uc758\ub8cc\uc6a9 \uc2a4\uc651\uc744 \uc81c\uacf5\ud558\uc9c0\ub9cc, \uc720\ub7fd \uc2dc\uc7a5\uc758 \ud3ec\uad04\uc801\uc778 \uaddc\uc815 \uc900\uc218, \ud488\uc9c8 \ubc0f \ud655\uc7a5\uc131 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \uacf3\uc740 \uac70\uc758 \uc5c6\uc2b5\ub2c8\ub2e4. EU \uc911\uc2ec \uad6c\ub9e4\uc790\ub97c \uc704\ud574, <a href=\"https:\/\/hanheng-medical.com\/ko\/about-us\/\">\uac15\uc18c \ud55c\ud765 \uc758\ub8cc \uae30\uc220 \uc720\ud55c \uacf5\uc0ac <\/a>\uace0\ud488\uc9c8\uc758 EU \uc900\uc218 \uc758\ub8cc \uac80\uc0ac \uc18c\ubaa8\ud488\uc744 \uc704\ud55c \uc911\uad6d \ucd5c\uace0 \uc81c\uc870\uc5c5\uccb4\ub85c \ub450\uac01\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-hanheng-is-the-leading-medical-swab-manufacturer-in-china\">Hanheng\uc774 \uc911\uad6d \ucd5c\uace0\uc758 \uc758\ub8cc\uc6a9 \uc2a4\uc651 \uc81c\uc870\uc5c5\uccb4\uc778 \uc774\uc720<\/h3>\n\n\n\n<p>2018\ub144\uc5d0 \uc124\ub9bd\ub41c \uc7a5\uc464\uc131 Hanheng\uc740 \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc744 \uc704\ud55c \uc9c4\ub2e8 \uc758\ub8cc \uc18c\ubaa8\ud488\uc758 \uc5f0\uad6c\uac1c\ubc1c \ubc0f \uc81c\uc870\ub97c \uc804\ubb38\uc73c\ub85c \ud569\ub2c8\ub2e4. 10,000\u33a1 \uaddc\ubaa8\uc758 ISO \ud074\ub798\uc2a4 100,000 \ud074\ub9b0\ub8f8\uacfc 32\uc5d0\uc774\ucee4 \uc81c\uc870 \ucea0\ud37c\uc2a4\ub97c \ubcf4\uc720\ud55c Hanheng\uc740 EU \uc218\uc785 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \ub300\uaddc\ubaa8 \ubb34\uade0 \uc0dd\uc0b0\uc744 \uc704\ud574 \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"hanheng-product-range-for-eu-markets\">EU \uc2dc\uc7a5\uc744 \uc704\ud55c Hanheng \uc81c\ud488 \ubc94\uc704<\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc81c\ud488<\/th><th>\uc758\ub8cc \uc560\ud50c\ub9ac\ucf00\uc774\uc158<\/th><th>CE \ub9c8\ud06c \ubd80\ucc29<\/th><th>MDR \ud074\ub798\uc2a4<\/th><\/tr><\/thead><tbody><tr><td>\ube44\uac15 \uba74\ubd09<\/td><td>COVID-19, \ub3c5\uac10, RSV \uac80\uc0ac<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><tr><td>\uc778\ud6c4 \uba74\ubd09<\/td><td>\ud638\ud761\uae30 \uc0d8\ud50c\ub9c1<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><tr><td>\uacbd\ubd80 \ube0c\ub7ec\uc26c<\/td><td>HPV \uc2a4\ud06c\ub9ac\ub2dd, \uc138\ud3ec\ud559<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 IIa<\/td><\/tr><tr><td>\ubd80\uc778\uacfc \uc2a4\ud06c\ub808\uc774\ud37c<\/td><td>\uc790\uad81\uacbd\ubd80 \uac80\uccb4 \ucc44\ucde8<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 IIa<\/td><\/tr><tr><td>\uc790\uad81\uacbd\ubd80 \uc0d8\ud50c \uc218\uc9d1\uae30<\/td><td>\uc790\uad81 \uacbd\ubd80 \ub3c4\ub9d0 \uac80\uc0ac, HPV<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 IIa<\/td><\/tr><tr><td>\uc0d8\ud50c\ub9c1 \ubc15\uc2a4<\/td><td>\uc6b4\uc1a1 \ubc0f \ubcf4\uc874<\/td><td>\u2714\ufe0f<\/td><td>\ud074\ub798\uc2a4 I<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\ubaa8\ub4e0 \uc81c\ud488\uc740 ISO9001 \ubc0f ISO13485 \ud488\uc9c8 \uc2dc\uc2a4\ud15c \ud558\uc5d0 \uc81c\uc870\ub418\uba70, Hanheng\uc758 \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub294 CE \ub9c8\ud06c\uc640 FDA \uc2b9\uc778 \ud488\ubaa9\uc744 \ud3ec\ud568\ud558\uc5ec EU \ubc0f \uae00\ub85c\ubc8c \uc2dc\uc7a5\uacfc\uc758 \ud638\ud658\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-sets-hanheng-apart-for-eu-distributors\">EU \uc720\ud1b5\uc5c5\uccb4\ub97c \uc704\ud55c Hanheng\uc758 \ucc28\ubcc4\ud654 \uc694\uc18c<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc644\uc804\ud55c MDR \ubc0f CE \ubb38\uc11c \uc9c0\uc6d0<\/li>\n\n\n\n<li>EU \uad6c\ub9e4\uc790\ub97c \uc704\ud55c \ub9de\ucda4 \ub77c\ubca8\ub9c1 \ubc0f OEM \uc11c\ube44\uc2a4<\/li>\n\n\n\n<li>\uae00\ub85c\ubc8c \ubb3c\ub958 \uc5ed\ub7c9\uc744 \ud1b5\ud55c \uc2e0\uc18d\ud55c \ub9ac\ub4dc \ud0c0\uc784<\/li>\n\n\n\n<li>\ubb34\uade0 \ubcf4\uc99d \ubc0f \ub192\uc740 \uc0d8\ud50c \ubcf4\uc874<\/li>\n\n\n\n<li>\ub9cc\uc871\ud55c \uc218\uc785\uc5c5\uccb4\uc640\uc758 EU \uc2dc\uc7a5 \uacbd\ud5d8<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"certifications-and-compliance\">\uc778\uc99d \ubc0f \uaddc\uc81c \uc900\uc218<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc778\uc99d<\/th><th>\uc124\uba85<\/th><\/tr><\/thead><tbody><tr><td>ISO13485<\/td><td>\uad6d\uc81c \uc758\ub8cc \uae30\uae30 \ud488\uc9c8 \uc2dc\uc2a4\ud15c<\/td><\/tr><tr><td>(\uc77c\ubc18 \ud488\uc9c8 \uad00\ub9ac)<\/td><td>\uc77c\ubc18 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c<\/td><\/tr><tr><td>CE<\/td><td>EU \uc548\uc804 \ubc0f \uc131\ub2a5 \uc900\uc218<\/td><\/tr><tr><td>FDA<\/td><td>\ubbf8\uad6d \uc2dc\uc7a5 \uc2b9\uc778<\/td><\/tr><tr><td>\ud2b9\ud5c8<\/td><td>\ud601\uc2e0\uc744 \uc704\ud55c \uc2e4\uc6a9 \uc2e0\uc548 \ud2b9\ud5c8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\uc911\uad6d\uc5d0\uc11c \uc2e0\ub8b0\ud560 \uc218 \uc788\uace0 \ud655\uc7a5 \uac00\ub2a5\ud558\uba70 \uaddc\uc81c \uc900\ube44\uac00 \ub41c \uacf5\uae09\uc790\ub97c \ucc3e\ub294 B2B \uad6c\ub9e4\uc790\ub97c \uc704\ud574 Hanheng\uc740 \uc6b0\ub9ac\uac00 \ucd94\ucc9c\ud558\ub294 \uc720\uc77c\ud55c \uc81c\uc870\uc5c5\uccb4\uc785\ub2c8\ub2e4. EU \uc218\uc785\uc5c5\uccb4\uc640\uc758 \uc785\uc99d\ub41c \uc2e4\uc801\uacfc \uad11\ubc94\uc704\ud55c \ubb38\uc11c \uc900\ube44 \uc0c1\ud0dc\uac00 \uadf8\ub4e4\uc744 \ucd5c\uc0c1\uc704 \ud30c\ud2b8\ub108\ub85c \ub9cc\ub4ed\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ud83d\udce9 \uc790\uc138\ud55c \uc815\ubcf4 \ub610\ub294 \uacac\uc801 \uc694\uccad\uc744 \uc704\ud574 Hanheng\uc5d0 \ubb38\uc758\ud558\uc138\uc694 <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a> \ub610\ub294 \ubc29\ubb38 <a href=\"https:\/\/hanheng-medical.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"5L0K7CcG8s\"><a href=\"https:\/\/hanheng-medical.com\/ko\/product\/polyurethane-foam-swab-nasal-specimen-collection-equipement-and-electronic-devices-cleaning-g-0124\/\">\ud3f4\ub9ac\uc6b0\ub808\ud0c4 \ud3fc \uba74\ubd09\/\ube44\uac15 \uac80\uccb4 \ucc44\ucde8\/\uc7a5\ube44 \ubc0f \uc804\uc790 \uc7a5\uce58 \uccad\uc18c G-0124<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&quot;\ud3f4\ub9ac\uc6b0\ub808\ud0c4 \ud3fc \uba74\ubd09\/\ube44\uac15 \uac80\uccb4 \ucc44\ucde8\/\uc7a5\ube44 \ubc0f \uc804\uc790 \uae30\uae30 \uccad\uc18c G-0124&quot; \u2014 Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/polyurethane-foam-swab-nasal-specimen-collection-equipement-and-electronic-devices-cleaning-g-0124\/embed\/#?secret=x7G4AbEOT2#?secret=5L0K7CcG8s\" data-secret=\"5L0K7CcG8s\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"6-the-role-of-authorized-representatives-and-importers-in-eu-medical-device-compliance\">6. EU \uc758\ub8cc \uae30\uae30 \uc900\uc218\ub97c \uc704\ud55c \uacf5\uc778 \ub300\ub9ac\uc778 \ubc0f \uc218\uc785\uc790\uc758 \uc5ed\ud560<\/h2>\n\n\n\n<p>Hanheng\uacfc \uac19\uc740 \ube44-EU \uc81c\uc870\uc5c5\uccb4\uc758 \uacbd\uc6b0 MDR 2017\/745\uc5d0 \ub530\ub77c EU \uc9c0\uc815 \ub300\ud45c\uc790(EU AR) \ubc0f \uc9c0\uc815 \uc218\uc785\uc5c5\uccb4\uc640 \ud611\ub825\ud558\ub294 \uac83\uc774 \ud544\uc218\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc5ed\ud560\uc758 \ucc45\uc784\uc744 \uc774\ud574\ud558\ub294 \uac83\uc740 EU\uc5d0\uc11c \uc6b4\uc601\ud558\ub294 \uc720\ud1b5\uc5c5\uccb4, \ub3c4\ub9e4\uc5c5\uccb4 \ubc0f \uc804\uc790\uc0c1\uac70\ub798 \ud310\ub9e4\uc790\uc5d0\uac8c \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"eu-authorized-representative-eu-ar\">EU \uc9c0\uc815\ub300\ub9ac\uc778 (EU AR)<\/h3>\n\n\n\n<p>EU AR\uc740 \uc720\ub7fd \uc5f0\ud569 \ub0b4\uc5d0 \ubcf8\uc0ac\ub97c \ub454 \ubc95\uc778\uc73c\ub85c, \ube44EU \uc81c\uc870\uc5c5\uccb4\ub97c \ub300\uc2e0\ud558\uc5ec \uaddc\uc81c \uc0ac\ud56d\uc744 \ucc98\ub9ac\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"responsibilities-of-the-eu-ar\">EU AR\uc758 \ucc45\uc784<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc2dc\uc7a5 \ucd9c\uc2dc \uc804\uc5d0 \uae30\uae30 \uc801\ud569\uc131 \ud655\uc778<\/li>\n\n\n\n<li>\uae30\uc220 \ubb38\uc11c \uc0ac\ubcf8 \ubcf4\uad00<\/li>\n\n\n\n<li>\uc0ac\uac74 \ubc1c\uc0dd \ub610\ub294 \uac10\uc0ac \uc2dc EU \ub2f9\uad6d\uacfc \ud611\ub825<\/li>\n\n\n\n<li>EUDAMED \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0 \uc81c\ud488 \ub4f1\ub85d<\/li>\n\n\n\n<li>\ub77c\ubca8\ub9c1 \ubc0f \uc9c0\uce68\uc774 EU \uc5b8\uc5b4 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub3c4\ub85d \ubcf4\uc7a5<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc694\uad6c \uc0ac\ud56d<\/th><th>\uc124\uba85<\/th><\/tr><\/thead><tbody><tr><td>\ubc95\uc801 \uc704\uce58<\/td><td>EU \ud68c\uc6d0\uad6d\uc5d0 \ubcf8\uc0ac\ub97c \ub46c\uc57c \ud568<\/td><\/tr><tr><td>\ub4f1\ub85d<\/td><td>\uc81c\ud488 \ub77c\ubca8\uc5d0 \uba85\uc2dc\ub418\uc5b4\uc57c \ud568<\/td><\/tr><tr><td>\ubb38\uc11c<\/td><td>\uc81c\uc870\uc5c5\uccb4\uc758 \uae30\uc220 \ud30c\uc77c \ubcf4\uc720<\/td><\/tr><tr><td>\ucc45\uc784<\/td><td>\uc81c\uc870\uc5c5\uccb4\uc640 \ubc95\uc801 \ucc45\uc784\uc744 \uacf5\uc720<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"importer-role-under-mdr\">MDR \ud558\uc758 \uc218\uc785\uc790 \uc5ed\ud560<\/h3>\n\n\n\n<p>\uc218\uc785\uc790\ub294 \uc81c\ud488\uc744 EU \uc2dc\uc7a5\uc5d0 \ucc98\uc74c \ucd9c\uc2dc\ud558\ub294 EU \ub0b4 \uccab \ubc88\uc9f8 \uc8fc\uccb4\uc785\ub2c8\ub2e4. \uc774 \ub2f9\uc0ac\uc790\ub294 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\ub294 \ub370 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"importer-responsibilities\">\uc218\uc785\uc790 \ucc45\uc784<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc218\uc785 \uc804\uc5d0 CE \ub9c8\ud0b9 \ubc0f EU \uc801\ud569\uc131 \uc120\uc5b8\uc11c \ud655\uc778<\/li>\n\n\n\n<li>\uc81c\uc870\uc5c5\uccb4\uac00 EU AR\uc744 \uc9c0\uc815\ud588\ub294\uc9c0 \ud655\uc778<\/li>\n\n\n\n<li>\ubd88\ub9cc \ubc0f \ubd80\uc801\ud569 \uc0ac\ud56d \ub4f1\ub85d\ubd80 \uc720\uc9c0<\/li>\n\n\n\n<li>\uc2ec\uac01\ud55c \uc0ac\uac74\uc744 \uc81c\uc870\uc5c5\uccb4 \ubc0f AR\uc5d0 \ubcf4\uace0<\/li>\n\n\n\n<li>UDI\uac00 \ubd80\ucc29\ub418\uace0 \ub4f1\ub85d\ub418\uc5c8\ub294\uc9c0 \ud655\uc778<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc791\uc5c5<\/th><th>\uc218\uc785\uc790\ub294 \ub2e4\uc74c\uc744 \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4\u2026<\/th><\/tr><\/thead><tbody><tr><td>\ub77c\ubca8 \ud655\uc778<\/td><td>\ub77c\ubca8\uc774 MDR \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778<\/td><\/tr><tr><td>CE \ud655\uc778<\/td><td>\uc81c\ud488\uc5d0 \uc720\ud6a8\ud55c CE \ub9c8\ud0b9\uc774 \uc788\ub294\uc9c0 \ud655\uc778<\/td><\/tr><tr><td>\uc0ac\uac74 \ubcf4\uace0<\/td><td>AR \ubc0f \uad00\ud560 \ub2f9\uad6d\uc5d0 \ud1b5\ubcf4<\/td><\/tr><tr><td>\uae30\ub85d \ubcf4\uad00<\/td><td>10\ub144 \ub3d9\uc548 \uac10\uc0ac \ucd94\uc801 \uae30\ub85d \uc720\uc9c0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"choosing-reliable-partners\">\uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ud30c\ud2b8\ub108 \uc120\ud0dd<\/h3>\n\n\n\n<p>B2B \uad6c\ub9e4\uc790 \ubc0f \uc720\ud1b5\uc5c5\uccb4\ub97c \uc704\ud55c:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU AR \ubc0f \uc218\uc785 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc774\ud574\ud558\ub294 \ud55c\ud5dd \uac19\uc740 \uc81c\uc870\uc5c5\uccb4\uc640 \ud611\ub825<\/li>\n\n\n\n<li>\ubb3c\ub958 \ud30c\ud2b8\ub108\uac00 MDR \uc218\uc785 \ubb38\uc11c\ub97c \uc798 \uc54c\uace0 \uc788\ub294\uc9c0 \ud655\uc778<\/li>\n\n\n\n<li>AR \ubc0f \uc218\uc785\uc744 \ud1b5\ud569\uc801\uc73c\ub85c \uc81c\uacf5\ud558\ub294 \ud480\uc11c\ube44\uc2a4 \uc218\uc785 \ub300\ub9ac\uc5c5\uccb4\uc640 \ud611\ub825 \uace0\ub824<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udcbc \uc804\ubb38 \ud301: <a href=\"https:\/\/hanheng-medical.com\/ko\/\">\ud55c\ud765<\/a> \ud55c\ud5dd\uc740 \uc720\ud1b5\uc5c5\uccb4\ub97c \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \uc644\uc804\ud55c MDR \ubb38\uc11c\ub97c \uc900\ube44\ud558\uba70, \uc758\ub8cc \uc18c\ubaa8\ud488 \ucc98\ub9ac\uc5d0 \uacbd\ud5d8\uc774 \ud48d\ubd80\ud55c EU AR \ud30c\ud2b8\ub108\ub97c \ucd94\ucc9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\ub7ec\ud55c \uc5ed\ud560\uc744 \uc774\ud574\ud558\ub294 \uac83\uc740 \ub2e8\uc21c\ud55c \uaddc\uc81c\uac00 \uc544\ub2c8\ub77c \uc804\ub7b5\uc801\uc785\ub2c8\ub2e4. \uaddc\uc815 \uc900\uc218 \ud30c\ud2b8\ub108\ub97c \uc120\ud0dd\ud558\uba74 \uc138\uad00 \ud1b5\uad00\uc774 \ub354 \ube60\ub974\uace0, \uc2dc\uc7a5 \ud6c4 \ubb38\uc81c\uac00 \uc801\uc73c\uba70, EU \uc2dc\uc7a5 \uc804\ubc18\uc5d0 \uac78\uce5c \ud655\uc7a5\uc774 \ub354 \uc6d0\ud65c\ud574\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"7-how-to-successfully-import-medical-swabs-into-the-eu-step-by-step-guide-for-distributors\">7. EU\ub85c \uc758\ub8cc \uc2a4\uc640\ube0c \uc131\uacf5\uc801 \uc218\uc785 \ubc29\ubc95: \uc720\ud1b5\uc5c5\uc790\ub97c \uc704\ud55c \ub2e8\uacc4\ubcc4 \uac00\uc774\ub4dc<\/h2>\n\n\n\n<p>B2B \uad6c\ub9e4\uc790, \uc218\uc785\uc790, \uc720\ud1b5\uc5c5\uccb4\uc5d0\uac8c \uc788\uc5b4 \uc720\ub7fd \uc5f0\ud569\uc73c\ub85c \uc758\ub8cc \uc2a4\uc651\uc744 \uc218\uc785\ud558\ub294 \uc804\uccb4 \ud504\ub85c\uc138\uc2a4\ub97c \uc774\ud574\ud558\ub294 \uac83\uc740 \uaddc\uc815 \uc900\uc218\uc640 \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uaddc\uc81c \ub610\ub294 \uc138\uad00 \ubb38\uc81c\ub97c \ud53c\ud558\ub294 \ub370 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \ub2e4\uc74c \ub2e8\uacc4\ubcc4 \uc124\uba85\uc740 MDR 2017\/745 \ud558\uc5d0\uc11c 2025\ub144\uc5d0 \uc131\uacf5\uc801\uc73c\ub85c \uc218\uc785\ud558\ub294 \ub370 \ud544\uc694\ud55c \ubaa8\ub4e0 \ub0b4\uc6a9\uc744 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"step-by-step-import-process-for-medical-swabs-into-the-eu\">EU\ub85c\uc758 \uc758\ub8cc \uc2a4\uc651 \uc218\uc785 \ub2e8\uacc4\ubcc4 \ud504\ub85c\uc138\uc2a4<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\ub2e8\uacc4<\/th><th>\uc124\uba85<\/th><th>\ucc45\uc784\uc790<\/th><\/tr><\/thead><tbody><tr><td>1. \uc81c\ud488 \ubd84\ub958<\/td><td>MDR \uae30\uae30 \ub4f1\uae09 \uacb0\uc815 (\uc608: \ud074\ub798\uc2a4 I, IIa)<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>2. CE \ub9c8\ud0b9<\/td><td>\uc81c\ud488\uc758 CE \uc801\ud569\uc131 \ubcf4\uc7a5<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>3. EU \uc9c0\uc815\ub300\ub9ac\uc778 \uc9c0\uc815<\/td><td>\uc81c\uc870\uc5c5\uccb4\uac00 EU \uc678\ubd80\uc5d0 \uc788\ub294 \uacbd\uc6b0 \ud544\uc218<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>4. \uc218\uc785\uc790 \uc120\ud0dd<\/td><td>\uae30\uae30\ub97c \uc2dc\uc7a5\uc5d0 \ucd9c\uc2dc\ud558\ub294 \ubc95\uc801 \uc8fc\uccb4<\/td><td>\uc720\ud1b5\uc5c5\uccb4 \ub610\ub294 \ubb3c\ub958 \ud30c\ud2b8\ub108<\/td><\/tr><tr><td>5. \ubb38\uc11c \ud655\uc778<\/td><td>DoC, CE \uc778\uc99d\uc11c, IFU, UDI, \ub77c\ubca8\ub9c1<\/td><td>\uc218\uc785\uc5c5\uc790<\/td><\/tr><tr><td>6. EUDAMED \ub4f1\ub85d<\/td><td>\uae30\uae30 \ubc0f \uacbd\uc81c \uc6b4\uc601\uc790 \ub4f1\ub85d<\/td><td>\uc81c\uc870\uc5c5\uccb4\/EU AR<\/td><\/tr><tr><td>7. \uc138\uad00 \uc2e0\uace0<\/td><td>TARIC \ucf54\ub4dc, VAT, \uad00\uc138, CE \ud655\uc778<\/td><td>\uc218\uc785\uc5c5\uccb4\/\uc138\uad00 \ube0c\ub85c\ucee4<\/td><\/tr><tr><td>8. \uc2dc\uc7a5 \ud6c4 \uac10\uc2dc<\/td><td>\ubd88\ub9cc \ucc98\ub9ac, \uc0ac\uac74 \ubcf4\uace0<\/td><td>\uc218\uc785\uc5c5\uccb4 &amp; EU AR<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\uc774\uc81c \uac01 \ub2e8\uacc4\ub97c \ub354 \uc790\uc138\ud788 \ubd84\ud574\ud574 \ubcf4\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"1-determine-product-classification-under-mdr\">1. MDR\uc5d0 \ub530\ub978 \uc81c\ud488 \ubd84\ub958 \uacb0\uc815<\/h3>\n\n\n\n<p>\uc9c4\ub2e8 \ub610\ub294 \uc0d8\ud50c\ub9c1 \ubaa9\uc801\uc73c\ub85c \uc0ac\uc6a9\ub418\ub294 \uc758\ub8cc \uc2a4\uc651\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ub2e4\uc74c\uacfc \uac19\uc774 \ubd84\ub958\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud074\ub798\uc2a4 I: \ube44\uac15, \uad6c\uc778\ub450 \uc2a4\uc651<\/li>\n\n\n\n<li>\ud074\ub798\uc2a4 IIa: \uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc, \ubd80\uc778\uacfc \uc2a4\ud06c\ub808\uc774\ud37c, \uc790\uad81\uacbd\ubd80 \uc0d8\ud50c \uc218\uc9d1\uae30<\/li>\n<\/ul>\n\n\n\n<p>\uc774 \ubd84\ub958\ub294 \uaddc\uc81c \uc2ec\uc0ac \uc218\uc900\uacfc \uc801\ud569\uc131 \ud3c9\uac00\ub97c \uc704\ud55c \ud1b5\uc9c0 \uae30\uad00\uc758 \ud544\uc694 \uc5ec\ubd80\ub97c \uacb0\uc815\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"2-ensure-ce-marking-technical-documentation\">2. CE \ub9c8\ud0b9 \ubc0f \uae30\uc220 \ubb38\uc11c \ud655\ubcf4<\/h3>\n\n\n\n<p>\uc81c\uc870\uc5c5\uccb4\ub294 \ub2e4\uc74c\uc744 \uc900\ube44\ud558\uace0 \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc801\ud569\uc131 \uc120\uc5b8(DoC)<\/li>\n\n\n\n<li>CE \uc778\uc99d\uc11c (\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0)<\/li>\n\n\n\n<li>\uae30\uc220 \ubb38\uc11c (MDR \ubd80\ub85d II &amp; III)<\/li>\n\n\n\n<li>\uc784\uc0c1 \ud3c9\uac00 \ubcf4\uace0\uc11c<\/li>\n\n\n\n<li>\uc704\ud5d8 \uad00\ub9ac \ud30c\uc77c<\/li>\n\n\n\n<li>\uba78\uade0 \uac80\uc99d (\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0)<\/li>\n<\/ul>\n\n\n\n<p>Hanheng\uc758 CE \ub9c8\ud0b9 \uc2a4\uc651\uc744 \uc0ac\uc6a9\ud558\uba74 \uc720\ud1b5\uc5c5\uccb4\ub294 \uc704 \ubaa8\ub4e0 \ubb38\uc11c\uac00 \uc774\uc6a9 \uac00\ub2a5\ud558\uace0 \uc900\uc218\ub428\uc744 \ud655\uc2e0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"3-assign-an-eu-authorized-representative\">3. EU \uacf5\uc778 \ub300\ub9ac\uc778 \uc9c0\uc815<\/h3>\n\n\n\n<p>EU AR\uc758 \uc5f0\ub77d\ucc98\ub294 \uc81c\ud488 \ub77c\ubca8\uacfc IFU\uc5d0 \ud45c\uc2dc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc758\ub8cc \uae30\uae30 \uacbd\ud5d8\uacfc EU \uaddc\uc81c \ub2f9\uad6d\uacfc\uc758 \uc6d0\ud65c\ud55c \uc18c\ud1b5 \ub2a5\ub825\uc744 \uac00\uc9c4 \ub300\ub9ac\uc778\uc744 \uc120\ud0dd\ud558\uc138\uc694.<\/p>\n\n\n\n<p>\ud83d\udca1 \ud301: Hanheng\uc740 \uc790\uc0ac \uc81c\ud488 \ub77c\uc778\uc5d0 \uc774\ubbf8 \uc775\uc219\ud55c \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 EU AR\uc744 \ucd94\ucc9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"4-select-an-importer\">4. \uc218\uc785\uc5c5\uccb4 \uc120\ud0dd<\/h3>\n\n\n\n<p>\uc218\uc785\uc5c5\uccb4\ub294 \uc81c\ud488\uc774 EU \uc2dc\uc7a5\uc5d0 \uc9c4\uc785\ud55c \ud6c4 \uaddc\uc81c \ub2f9\uad6d\uc758 \uccab \ubc88\uc9f8 \uc5f0\ub77d\ucc98\uac00 \ub429\ub2c8\ub2e4. \uc790\uccb4\uc801\uc73c\ub85c \uc218\uc785\uc5c5\uccb4 \uc5ed\ud560\uc744 \ud558\uac70\ub098 \ubb3c\ub958 \ud30c\ud2b8\ub108\uc640 \ud611\ub825\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc218\uc785\uc5c5\uccb4 \uc694\uad6c \uc0ac\ud56d\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc2dc\uc7a5 \ucd9c\uc2dc \uc804\uc5d0 CE \ubc0f DoC \ud655\uc778<\/li>\n\n\n\n<li>\uc544\uc9c1 \ub4f1\ub85d\ub418\uc9c0 \uc54a\uc740 \uacbd\uc6b0 EUDAMED \ub4f1\ub85d<\/li>\n\n\n\n<li>\ubd88\ub9cc \ubc0f \ub9ac\ucf5c \ub85c\uadf8 \uc720\uc9c0<\/li>\n\n\n\n<li>\uc911\ub300 \uc0ac\uac74 \ubcf4\uace0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"5-verify-product-documentation-before-shipment\">5. \uc120\uc801 \uc804 \uc81c\ud488 \ubb38\uc11c \ud655\uc778<\/h3>\n\n\n\n<p>\uc218\uc785 \uc804\uc5d0 \ub2e4\uc74c \ubb38\uc11c\ub97c \uac80\ud1a0\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud074\ub798\uc2a4 I\uc758 \uacbd\uc6b0 CE \uc778\uc99d\uc11c \ub610\ub294 \uc790\uccb4 \uc778\uc99d<\/li>\n\n\n\n<li>\uc801\uc808\ud55c EU \uc5b8\uc5b4\ub85c \ub41c DoC<\/li>\n\n\n\n<li>UDI, EU AR \ubc0f \uc218\uc785\uc5c5\uccb4 \uc8fc\uc18c\uac00 \ud3ec\ud568\ub41c \ub77c\ubca8\ub9c1<\/li>\n\n\n\n<li>\uc0ac\uc6a9 \uc124\uba85\uc11c(IFU)<\/li>\n\n\n\n<li>ISO13485 \ubc0f ISO9001 \uc778\uc99d\uc11c<\/li>\n\n\n\n<li>\uba78\uade0 \ubc0f \uc0dd\uccb4 \uc801\ud569\uc131 \ubcf4\uace0\uc11c<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"6-register-in-eudamed\">6. EUDAMED \ub4f1\ub85d<\/h3>\n\n\n\n<p>\uc758\ub8cc \uae30\uae30 \uc720\ub7fd \ub370\uc774\ud130\ubca0\uc774\uc2a4(EUDAMED)\ub294 \ub2e4\uc74c\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uae30\ubcf8 UDI-DI \ub4f1\ub85d<\/li>\n\n\n\n<li>\uacbd\uc81c \uc6b4\uc601\uc790 \ub4f1\ub85d (SRN)<\/li>\n\n\n\n<li>\uae30\uae30 \ub4f1\ub85d<\/li>\n\n\n\n<li>\uacbd\uacc4 \ubc0f \uc2dc\uc7a5 \ud6c4 \ubaa8\ub2c8\ud130\ub9c1<\/li>\n<\/ul>\n\n\n\n<p>EUDAMED \ub4f1\ub85d\uc740 \ubaa8\ub4e0 \ud074\ub798\uc2a4 I \uc774\uc0c1 \uae30\uae30\uc5d0 \ub300\ud574 \uc810\uc810 \ub354 \ud544\uc218\uc801\uc73c\ub85c \ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"7-clear-eu-customs\">7. EU \uc138\uad00 \ud1b5\uad00<\/h3>\n\n\n\n<p>\uc138\uad00 \ud1b5\uad00\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EORI \ubc88\ud638 (\uacbd\uc81c \uc6b4\uc601\uc790 \ub4f1\ub85d \ubc0f \uc2dd\ubcc4)<\/li>\n\n\n\n<li>TARIC \ucf54\ub4dc (\uc608: \uc9c4\ub2e8 \uc2dc\uc57d\uc758 \uacbd\uc6b0 3822.00.00)<\/li>\n\n\n\n<li>CE \uc801\ud569\uc131 \uc99d\uba85<\/li>\n\n\n\n<li>\uc0c1\uc5c5 \uc1a1\uc7a5<\/li>\n\n\n\n<li>\uc120\ud558\uc99d\uad8c \ub610\ub294 \ud56d\uacf5\ud654\ubb3c\uc6b4\uc1a1\uc7a5<\/li>\n\n\n\n<li>\ud3ec\uc7a5 \ubaa9\ub85d<\/li>\n\n\n\n<li>\ud574\ub2f9 \uc218\uc785 \ubd80\uac00\uac00\uce58\uc138 \ubc0f \uad00\uc138 \ub0a9\ubd80<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udca1 \uba78\uade0 \uc2a4\uc651\uc758 TARIC \ucf54\ub4dc: 3005.90.10 (\uc758\ub8cc\uc6a9)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"8-maintain-post-market-compliance\">8. \uc2dc\ud310 \ud6c4 \uaddc\uc815 \uc900\uc218 \uc720\uc9c0<\/h3>\n\n\n\n<p>\uc218\uc785 \ud6c4 \uc9c0\uc18d\uc801\uc778 \uc758\ubb34\uac00 \ubc1c\uc0dd\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc81c\ud488 \ucd94\uc801\uc131 \uc720\uc9c0<\/li>\n\n\n\n<li>\uc81c\uc870\uc0ac \ubc0f EU AR\uc5d0 \uc0ac\uac74 \ubcf4\uace0<\/li>\n\n\n\n<li>\uc8fc\ubb34 \ub2f9\uad6d \ubb38\uc758\uc5d0 \uc751\ub2f5<\/li>\n\n\n\n<li>\ud544\uc694 \uc2dc \ub9ac\ucf5c \ub610\ub294 \ud604\uc7a5 \uc548\uc804 \uc870\uce58 \uad00\ub9ac<\/li>\n<\/ul>\n\n\n\n<p>\uc774 \uc804\uccb4 \uc8fc\uae30 \uac00\uc774\ub4dc\ub97c \ub530\ub974\uba74 EU \uae30\ubc18 \uc218\uc785\uc5c5\uccb4 \ubc0f \uc720\ud1b5\uc5c5\uccb4\ub294 \uaddc\uc815 \uc900\uc218 \ud504\ub85c\uc138\uc2a4\ub97c \uac04\uc18c\ud654\ud558\uace0 \uc2e0\ub8b0\ud560 \uc218 \uc788\uc73c\uba70 \ud655\uc7a5 \uac00\ub2a5\ud55c \uc758\ub8cc \uc2a4\uc651 \uacf5\uae09\ub9dd\uc744 \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2938\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2.jpg\" alt=\"\" class=\"wp-image-2938\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2949\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Viscose-FabricRayon-Tipped-SwabPlastic-ShaftLarge-area-Sampling-or-CleaningMolded-Breakpoint-E-03-3.jpg\" alt=\"\" class=\"wp-image-2949\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Viscose-FabricRayon-Tipped-SwabPlastic-ShaftLarge-area-Sampling-or-CleaningMolded-Breakpoint-E-03-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Viscose-FabricRayon-Tipped-SwabPlastic-ShaftLarge-area-Sampling-or-CleaningMolded-Breakpoint-E-03-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Viscose-FabricRayon-Tipped-SwabPlastic-ShaftLarge-area-Sampling-or-CleaningMolded-Breakpoint-E-03-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Viscose-FabricRayon-Tipped-SwabPlastic-ShaftLarge-area-Sampling-or-CleaningMolded-Breakpoint-E-03-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2943\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3.jpg\" alt=\"\" class=\"wp-image-2943\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"8-common-challenges-and-how-to-avoid-compliance-pitfalls-in-2025\">8. 2025\ub144 \uc77c\ubc18\uc801\uc778 \ub3c4\uc804 \uacfc\uc81c\uc640 \uaddc\uc81c \uc900\uc218 \ud568\uc815 \ud53c\ud558\ub294 \ubc29\ubc95<\/h2>\n\n\n\n<p>EU\ub85c \uc758\ub8cc \uc2a4\uc651\uc744 \uc218\uc785\ud558\ub294 \uac83\uc740 \uac04\ub2e8\ud574 \ubcf4\uc77c \uc218 \uc788\uc9c0\ub9cc, \ub9ce\uc740 \uc720\ud1b5\uc5c5\uccb4\uc640 \ub3c4\ub9e4\uc5c5\uccb4\uac00 \ubc30\uc1a1 \uc9c0\uc5f0, \ubc8c\uae08 \ubd80\uacfc, \ub610\ub294 \uaddc\uc81c \uae30\uad00\uacfc\uc758 \uad00\uacc4 \uc190\uc0c1\uc744 \ucd08\ub798\ud558\ub294 \ud53c\ud560 \uc218 \uc788\ub294 \uc2e4\uc218\ub97c \uc800\uc9c0\ub985\ub2c8\ub2e4. \uac00\uc7a5 \ud754\ud55c \ud568\uc815\uacfc \uc774\ub97c \ud53c\ud558\ub294 \ubc29\ubc95\uc744 \uc774\ud574\ud558\uba74 \uc2dc\uac04, \ube44\uc6a9, \uba85\uc131\uc744 \uc808\uc57d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"top-6-compliance-pitfalls-when-importing-medical-swabs\">\uc758\ub8cc \uc2a4\uc651 \uc218\uc785 \uc2dc \uc0c1\uc704 6\uac00\uc9c0 \uaddc\uc815 \uc900\uc218 \ud568\uc815<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\ud568\uc815<\/th><th>\uc704\ud5d8<\/th><th>\ud53c\ud558\ub294 \ubc29\ubc95<\/th><\/tr><\/thead><tbody><tr><td>\ub204\ub77d\ub418\uac70\ub098 \ubb34\ud6a8\uc778 CE \ub9c8\ud0b9<\/td><td>\uc81c\ud488 \uc555\uc218, \ubc8c\uae08<\/td><td>Hanheng\uc640 \uac19\uc740 CE \uc900\uc218 \uc81c\uc870\uc0ac\ub85c\ubd80\ud130\ub9cc \uc870\ub2ec<\/td><\/tr><tr><td>\uc9c0\uc815\ub41c EU \uacf5\uc778 \ub300\ub9ac\uc778 \uc5c6\uc74c<\/td><td>\uc138\uad00 \uac70\ubd80<\/td><td>\uc120\uc801 \uc804\uc5d0 AR \uc9c0\uc815<\/td><\/tr><tr><td>\uc798\ubabb\ub41c \uc81c\ud488 \ubd84\ub958<\/td><td>\uac10\uc0ac \uc2e4\ud328, \uc2dc\uc7a5 \uae08\uc9c0<\/td><td>\uc81c\uc870\uc0ac\uc640 MDR \ubd84\ub958 \ud655\uc778<\/td><\/tr><tr><td>\ubd88\uc644\uc804\ud55c \uae30\uc220 \ubb38\uc11c<\/td><td>\uc138\uad00 \ub610\ub294 \uac10\uc2dc \uc9c0\uc5f0<\/td><td>\uc8fc\ubb38 \uc804\uc5d0 \uc804\uccb4 \ubb38\uc11c \uc694\uccad<\/td><\/tr><tr><td>EU \uc5b8\uc5b4\uac00 \uc544\ub2cc \ub77c\ubca8\ub9c1<\/td><td>\uaddc\uc815 \ubbf8\uc900\uc218<\/td><td>\ub77c\ubca8\ub9c1 \ubc0f IFU \ubc88\uc5ed \ud655\uc778<\/td><\/tr><tr><td>\ud3ec\uc7a5\uc5d0 UDI \ubd80\uc7ac<\/td><td>\uaddc\uc81c \ucc98\ubc8c<\/td><td>\uc81c\uc870\uc0ac\uc5d0 \uc758\ud574 UDI \ubd80\ucc29 \ud655\uc778<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"real-world-import-challenges\">\uc2e4\uc81c \uc218\uc785 \ub3c4\uc804 \uacfc\uc81c<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ub3c5\uc77c\uc758 \ub300\ud615 \uc9c4\ub2e8 \uc720\ud1b5\uc5c5\uccb4\uac00 CE \ubb38\uc11c \ub204\ub77d\uc73c\ub85c 5,000\uac1c\uc758 \uc790\uad81\uacbd\ubd80 \uc2a4\uc651\uc774 \uc138\uad00\uc5d0 \uc555\ub958\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ud504\ub791\uc2a4 \ubcd1\uc6d0 \uc870\ub2ec \uae30\uad00\uc774 IFU\uac00 \uc911\uad6d\uc5b4\uc640 \uc601\uc5b4\ub9cc \ud3ec\ud568\ub418\uc5b4 \uc788\uc5b4 \uc120\uc801\uc744 \uac70\ubd80\ud588\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc601\uad6d \uae30\ubc18 \uc218\uc785\uc5c5\uccb4(\ube0c\ub809\uc2dc\ud2b8 \uc774\uc804)\uac00 \ud074\ub798\uc2a4 IIa \uae30\uae30\ub97c \uc218\uc785\ud55c \ud6c4 EUDAMED\uc5d0 \ub4f1\ub85d\ud558\uc9c0 \uc54a\uc544 \ubc8c\uae08\uc744 \ubd80\uacfc\ubc1b\uc558\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"how-to-stay-ahead-in-2025\">2025\ub144\uc5d0 \uc55e\uc11c \ub098\uac00\uae30<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU \uc900\uc218 \uacbd\ud5d8\uc73c\ub85c \uc785\uc99d\ub41c Hanheng\uc640 \uac19\uc740 \uac80\uc99d\ub41c \uc81c\uc870\uc0ac\uc640\ub9cc \ud611\ub825<\/li>\n\n\n\n<li>\ubaa8\ub4e0 \uc8fc\ubb38\uc5d0 \ub300\ud574 \uc120\uc801 \uc804 \uccb4\ud06c\ub9ac\uc2a4\ud2b8 \uac10\uc0ac \uc2e4\uc2dc<\/li>\n\n\n\n<li>\uc758\ub8cc \uae30\uae30 \ud504\ub85c\ud1a0\ucf5c\uc5d0 \uc775\uc219\ud55c \uc218\uc785 \ub300\ub9ac\uc778 \ub610\ub294 \uc138\uad00 \ube0c\ub85c\ucee4 \ud65c\uc6a9<\/li>\n\n\n\n<li>\uc720\ub7fd \uc704\uc6d0\ud68c \uc758\ub8cc \uae30\uae30 \ubd80\ubb38 \uc5c5\ub370\uc774\ud2b8 \uad6c\ub3c5<\/li>\n\n\n\n<li>\uc218\uc785 \ubc0f \uc720\ud1b5 \ud504\ub85c\uc138\uc2a4\uc758 \ubaa8\ub4e0 \ub2e8\uacc4\ub97c \ubb38\uc11c\ud654<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"compliance-checklist-for-eu-importers\">EU \uc218\uc785\uc5c5\uccb4\ub97c \uc704\ud55c \uaddc\uc815 \uc900\uc218 \uccb4\ud06c\ub9ac\uc2a4\ud2b8<\/h3>\n\n\n\n<p>\u2705 CE \ub9c8\ud06c \ubc0f MDR \uc77c\uce58 \ud655\uc778<br>\u2705 EU AR \uc9c0\uc815 \ubc0f \ubaa9\ub85d \ud655\uc778<br>\u2705 \ubaa8\ub4e0 \uae30\uc220 \ubb38\uc11c \uac80\ud1a0 \ubc0f \ubcf4\uad00<br>\u2705 \ub77c\ubca8\ub9c1 \ubc0f IFU\uac00 \uc5b8\uc5b4\/\ubc95\uc801 \uc694\uad6c\uc0ac\ud56d \ucda9\uc871 \ud655\uc778<br>\u2705 EUDAMED\uc5d0 \uae30\uae30 \ubc0f \uc6b4\uc601\uc790 \ub4f1\ub85d<br>\u2705 \uc2dc\ud310 \ud6c4 \uc131\ub2a5 \ubc0f \uc0ac\uac74 \ubcf4\uace0 \ubaa8\ub2c8\ud130\ub9c1<\/p>\n\n\n\n<p>EU \uc758\ub8cc \uc18c\ubaa8\ud488 \uc2dc\uc7a5\uc5d0\uc11c \uc131\uacf5\uc801\uc778 \uc7a5\uae30 \uc6b4\uc601\uc758 \ud575\uc2ec\uc740 \uc801\uadf9\uc801 \ub300\uc751\u2014\uc218\ub3d9\uc801 \ub300\uc751\uc774 \uc544\ub2cc\u2014\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"9-faqs-navigating-eu-import-rules-for-medical-swabs\">9. FAQ: EU \uc758\ub8cc \uc2a4\uc640\ube0c \uc218\uc785 \uaddc\uc815 \ud0d0\uc0c9<\/h2>\n\n\n\n<p>\uc544\ub798\ub294 2025\ub144 EU\ub85c\uc758 \uc2a4\uc640\ube0c \uc218\uc785\uc5d0 \uad00\ud55c B2B \uad6c\ub9e4\uc790, \uc218\uc785\uc5c5\uc790 \ubc0f \uc758\ub8cc \uc720\ud1b5\uc5c5\uccb4\ub85c\ubd80\ud130\uc758 \uac00\uc7a5 \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38\ub4e4\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q1-do-all-medical-swabs-require-ce-marking\">Q1: \ubaa8\ub4e0 \uc758\ub8cc\uc6a9 \uc2a4\uc640\ube0c\uc5d0 CE \ub9c8\ud0b9\uc774 \ud544\uc694\ud55c\uac00\uc694?<\/h3>\n\n\n\n<p>\ub124. \uc2a4\uc640\ube0c\uac00 \uc758\ub8cc \ub610\ub294 \uc9c4\ub2e8 \uc6a9\ub3c4(\uc608: \ube44\uc778\ub450, \uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc)\ub85c \uc0ac\uc6a9\ub418\ub294 \uacbd\uc6b0 MDR 2017\/745\uc5d0 \ub530\ub77c CE \ub9c8\ud0b9\uc774 \ud544\uc218\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q2-what-class-are-medical-swabs-under-mdr\">Q2: MDR\uc5d0 \ub530\ub978 \uc758\ub8cc\uc6a9 \uc2a4\uc640\ube0c\uc758 \ub4f1\uae09\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ube44\uac15\/\uc778\ub450 \uc2a4\uc640\ube0c: \ud074\ub798\uc2a4 I<\/li>\n\n\n\n<li>\uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc\/\uc2a4\ud06c\ub808\uc774\ud37c: \ud074\ub798\uc2a4 IIa<\/li>\n\n\n\n<li>\uc790\uac00 \ucc44\ucde8 \ud0a4\ud2b8: \ub2e4\uc591\ud560 \uc218 \uc788\uc9c0\ub9cc \uc885\uc885 \ud074\ub798\uc2a4 IIa<\/li>\n<\/ul>\n\n\n\n<p>\ud56d\uc0c1 \uc758\ub3c4\ub41c \uc6a9\ub3c4\ub97c \ud655\uc778\ud558\uace0 \uc81c\uc870\uc0ac\uc758 \ubd84\ub958 \uadfc\uac70\ub97c \uc0c1\ub2f4\ud558\uc138\uc694.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q3-what-documents-should-i-request-from-a-supplier-like-hanheng\">Q3: Hanheng \uac19\uc740 \uacf5\uae09\uc5c5\uccb4\ub85c\ubd80\ud130 \uc5b4\ub5a4 \ubb38\uc11c\ub97c \uc694\uccad\ud574\uc57c \ud558\ub098\uc694?<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc801\ud569\uc131 \uc120\uc5b8<\/li>\n\n\n\n<li>CE \uc778\uc99d\uc11c(\ud074\ub798\uc2a4 IIa\uc778 \uacbd\uc6b0)<\/li>\n\n\n\n<li>\uae30\uc220 \ud30c\uc77c(\ubd80\ub85d II)<\/li>\n\n\n\n<li>\uba78\uade0 \ubcf4\uace0\uc11c<\/li>\n\n\n\n<li>ISO13485 \ubc0f ISO9001 \uc778\uc99d<\/li>\n\n\n\n<li>EU \uc5b8\uc5b4\ub85c \ub41c \uc0ac\uc6a9 \uc9c0\uce68 \ubc0f \ub77c\ubca8\ub9c1<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q4-can-i-import-swabs-without-an-eu-authorized-representative\">Q4: EU \uacf5\uc778 \ub300\ub9ac\uc778 \uc5c6\uc774 \uc2a4\uc640\ube0c\ub97c \uc218\uc785\ud560 \uc218 \uc788\ub098\uc694?<\/h3>\n\n\n\n<p>\uc544\ub2c8\uc694. \uc81c\uc870\uc0ac\uac00 EU \uc678\ubd80\uc5d0 \uc788\ub294 \uacbd\uc6b0 \uacf5\uc778 \ub300\ub9ac\uc778\uc740 \ud544\uc218\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q5-does-hanheng-support-eu-import-compliance\">Q5: Hanheng\uc774 EU \uc218\uc785 \uaddc\uc815 \uc900\uc218\ub97c \uc9c0\uc6d0\ud558\ub098\uc694?<\/h3>\n\n\n\n<p>\ub124. Hanheng\uc740 MDR \uc900\uc218 \ubb38\uc11c, CE \ub9c8\ud0b9 \uc81c\ud488\uc744 \uc81c\uacf5\ud558\uba70, \uc758\ub8cc \uae30\uae30 \uc218\uc785\uc5d0 \uacbd\ud5d8\uc774 \uc788\ub294 EU AR \ubc0f \ubb3c\ub958 \ud30c\ud2b8\ub108\ub97c \ucd94\ucc9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q6-are-there-import-duties-on-medical-swabs\">Q6: \uc758\ub8cc\uc6a9 \uc2a4\uc640\ube0c\uc5d0 \uc218\uc785 \uad00\uc138\uac00 \ubd80\uacfc\ub418\ub098\uc694?<\/h3>\n\n\n\n<p>\uc758\ub8cc\uc6a9 \uc2a4\uc640\ube0c\ub294 \ud2b9\uc815 TARIC \ucf54\ub4dc\uc5d0 \ub530\ub77c \uad00\uc138 \uac10\uba74 \ub610\ub294 \uba74\uc81c \ub300\uc0c1\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uad6d\uac00\uc5d0 \ub530\ub77c \uc218\uc785 \ubd80\uac00\uac00\uce58\uc138\ub294 \uc5ec\uc804\ud788 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q7-can-i-private-label-hanheng-products-for-my-eu-brand\">Q7: Hanheng \uc81c\ud488\uc744 \ub0b4 EU \ube0c\ub79c\ub4dc\ub85c \uc0ac\uc124 \ub77c\ubca8\ub9c1\ud560 \uc218 \uc788\ub098\uc694?<\/h3>\n\n\n\n<p>\ub124. Hanheng\uc740 CE \uc900\uc218 \ubb38\uc11c\ub97c \uc81c\uacf5\ud558\ub294 OEM\/\uc0ac\uc124 \ub77c\ubca8\ub9c1 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\uba70, \uc790\uccb4 \ube0c\ub79c\ub4dc\ub85c \ud655\uc7a5\ud558\ub824\ub294 \uc720\ud1b5\uc5c5\uccb4\uc5d0\uac8c \uc774\uc0c1\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q8-how-do-i-ensure-my-products-are-registered-in-eudamed\">Q8: \uc81c\ud488\uc774 EUDAMED\uc5d0 \ub4f1\ub85d\ub418\uc5c8\ub294\uc9c0 \uc5b4\ub5bb\uac8c \ud655\uc778\ud558\ub098\uc694?<\/h3>\n\n\n\n<p>\uc81c\uc870\uc0ac \ubc0f EU AR\uc640 \ud611\ub825\ud558\uc5ec \uae30\ubcf8 UDI-DI\uc640 \uc81c\ud488 \ubaa9\ub85d\uc744 EUDAMED \uc2dc\uc2a4\ud15c\uc5d0 \ub4f1\ub85d\ud558\uc138\uc694.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\ud83e\uddea EU \uaddc\uc815 \uc900\uc218 \uc2a4\uc640\ube0c \uacf5\uae09\ub9dd \uad6c\ucd95 \uc900\ube44 \ub418\uc168\ub098\uc694?<\/p>\n\n\n\n<p><a href=\"https:\/\/hanheng-medical.com\/ko\/contact-us\/\">\uc7a5\uc464 \ud55c\ud5dd \uc758\ub8cc \uae30\uc220 <\/a>\uace0\uc131\ub2a5 CE \uc778\uc99d \uc0d8\ud50c\ub9c1 \uc18c\ubaa8\ud488\uc758 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ud30c\ud2b8\ub108\uc785\ub2c8\ub2e4. \uacac\uc801, \ubb38\uc11c \uac80\ud1a0 \ub610\ub294 \uaddc\uc815 \uc900\uc218 \uc0c1\ub2f4\uc744 \uc704\ud574 \uc624\ub298 \uc5f0\ub77d\ud558\uc138\uc694:<\/p>\n\n\n\n<p>\ud83c\udf10 \uc6f9\uc0ac\uc774\ud2b8: <a href=\"https:\/\/hanheng-medical.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><br>\ud83d\udce7 \uc774\uba54\uc77c: <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/p>\n\n\n\n<p>Hanheng\uacfc \ud568\uaed8 \ub354 \uc2a4\ub9c8\ud2b8\ud558\uace0 \uc548\uc804\ud558\uac8c \uc218\uc785\uc744 \uc2dc\uc791\ud558\uc138\uc694\u2014EU \uc2dc\uc7a5\uc744 \uc704\ud55c \uae00\ub85c\ubc8c \uc758\ub8cc \uc2a4\uc640\ube0c 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