{"id":13875,"date":"2023-05-23T05:54:05","date_gmt":"2023-05-23T05:54:05","guid":{"rendered":"https:\/\/www.registrarcorp.com\/medical-devices\/"},"modified":"2025-07-23T08:26:02","modified_gmt":"2025-07-23T08:26:02","slug":"%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0","status":"publish","type":"page","link":"https:\/\/www.registrarcorp.com\/ko\/industries\/medical-devices\/","title":{"rendered":"\uc758\ub8cc\uae30\uae30"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_section][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1751894926980{padding-top: 85px !important;padding-bottom: 0px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;hero-section max-breakpoint-md&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]\n<h1 class=\"banner-title\"><strong>\uc758\ub8cc \uae30\uae30 \uaddc\uc815 \uc900\uc218\uc640 \uad00\ub828\ud558\uc5ec<span style=\"color: #0081ff;\"> 510(k) \uba74\uc81c\ub294 \uaddc\uc81c\ub418\uc9c0 \uc54a\uc74c\uc744 \uc758\ubbf8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/strong><\/h1>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h4=&#8221;Montserrat&#8221; fnt_size_h4=&#8221;24px&#8221; el_class=&#8221;text-neutral-700&#8243;]\ub9ce\uc740 \uc0ac\ub78c\ub4e4\uc774 <strong>510(k) \uba74\uc81c<\/strong>\ud3c9\uade0\uc744 \uac10\ub3c5\ud558\uc9c0 \uc54a\ub294\ub2e4\uace0 \uac00\uc815\ud558\uc9c0\ub9cc \uba74\uc81c\ub41c \uc7a5\uce58\uc870\ucc28\ub3c4 FDA \ubc0f \uae00\ub85c\ubc8c \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c \ub2e8\uacc4\ub97c \uac04\uacfc\ud558\uba74 <strong>\ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc9c0\uc5f0, \uc218\uc785 \uc5b5\ub958 \ub610\ub294 \uc2ec\uc9c0\uc5b4 \uc2dc\uc7a5 \ucca0\uc218\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/strong> <\/p>\n<p>\ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ud558\uae30 \uc804, \uccab \ubc88\uc9f8 \ub2e8\uacc4\ub294 <strong>\ub4f1\ub85d\uc744 \uc62c\ubc14\ub974\uac8c \uc644\ub8cc\ud558\ub294 \uac83\uc785\ub2c8\ub2e4<\/strong>.[\/vc_column_text][vc_btn title=&#8221;FDA\uc5d0 \ub4f1\ub85d&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-registration%2Fmedical-devices%2F|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_video link=&#8221;https:\/\/www.youtube.com\/watch?v=FOXeZ64HRlA&#8221; css=&#8221;&#8221; el_class=&#8221;m-width-desktop-560 ms-xl-auto&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1744037944502{padding-top: 0px !important;background-color: #FFFFFF !important;}&#8221;][vc_row css=&#8221;.vc_custom_1744032680022{background-color: #FFFFFF !important;}&#8221;][vc_column][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 mb-mobile-32&#8243;]\n<h2 style=\"text-align: center;\">\uc120\ub3c4\uc801\uc778 \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac \uc2e0\ud0c1 \ub4f1\ub85d \ud68c\uc0ac<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; el_class=&#8221;text-neutral-700&#8243;]\n<p style=\"text-align: center;\"><strong>20\ub144 \uc774\uc0c1\uc758 \uacbd\ud5d8\uacfc<\/strong> 3,500\uac1c \uc774\uc0c1\uc758 \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac \uc9c0\uc6d0\uc73c\ub85c <strong>Registrar Corp\ub294 \uaddc\uc815 \uc900\uc218\ub97c \uac04\uc18c\ud654\ud569\ub2c8\ub2e4.<\/strong><\/p>\n[\/vc_column_text][vc_empty_space height=&#8221;60px&#8221;]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div 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src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ASOS-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - ASOS\" title=\"logo-grey-ASOS\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ASOS-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ASOS.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Thusane-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Thusane\" title=\"logo-grey-Thusane\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Thusane-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Thusane.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Lovehoney-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Lovehoney\" title=\"logo-grey-Lovehoney\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Lovehoney-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Lovehoney.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Moncler-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Moncler\" title=\"logo-grey-Moncler\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Moncler-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Moncler.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-mytheresa-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Mytheresa\" title=\"logo-grey-mytheresa\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-mytheresa-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-mytheresa.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThomasScientific-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Thomas Scientific\" title=\"logo-grey-ThomasScientific\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThomasScientific-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThomasScientific.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThommenMedical-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Logo - Thommen Medical\" title=\"logo-grey-ThommenMedical\" srcset=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThommenMedical-300x94.webp 300w, https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-ThommenMedical.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><div class=\"mpc-navigation mpc-init mpc-align--left mpc-navigation--style_1  mpc-nav-preset--\" data-mpcslider=\"mpc_carousel_image-856a34467e6a8b9\"><div class=\"mpc-nav__arrow mpcslick-prev\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><div class=\"mpc-nav__arrow mpcslick-next\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><\/div><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1744033064028{padding-top: 0px !important;background-color: #EEF6FB !important;}&#8221;][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743769302115{background-color: #EEF6FB !important;}&#8221;][vc_column offset=&#8221;vc_col-sm-offset-0&#8243;][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>\uaddc\uc815 \uc900\uc218 \ub85c\ub4dc\ub9f5<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221;]\n<p style=\"text-align: center;\">\uc758\ub8cc \uae30\uae30 \uaddc\uc815 \ud0d0\uc0c9\uc740 \ubcf5\uc7a1\ud560 \uc218 \uc788\uc9c0\ub9cc, \uc555\ub3c4\uc801\uc77c \ud544\uc694\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \ub2f9\uc0ac\ub294 \ubb34\ud55c\ud55c \uaddc\uc81c\ub97c \uccb4\uc9c8\ud558\ub294 \ub300\uc2e0, \uc774\ub97c \uac04\ub2e8\ud55c \ub2e8\uacc4\ub85c \uc138\ubd84\ud654\ud558\uc5ec \uc27d\uac8c \ucd9c\uc2dc\ud560 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4.<\/p>\n[\/vc_column_text][vc_empty_space height=&#8221;75px&#8221;][vc_row_inner][vc_column_inner el_class=&#8221;d-none d-lg-block&#8221; width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;53760&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-1 active&#8221;][vc_single_image image=&#8221;53770&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-2&#8243;][vc_single_image image=&#8221;53780&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-3&#8243;][vc_single_image image=&#8221;53790&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-4&#8243;][vc_single_image image=&#8221;53799&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-5&#8243;][vc_single_image image=&#8221;53809&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-6&#8243;][vc_single_image image=&#8221;53818&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;compliance-roadmap-image step-7&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;&#8221;]\n<ul class=\"compliance-roadmap desktop d-none d-lg-block\">\n<li class=\"active\">1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;14px&#8221;][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-1 active&#8221;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\" style=\"margin-top: -30px;\">\n<li class=\"active\">1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53760&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/strong><\/h4>\n<p>\ud574\uc678 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub294 FDA \ucee4\ubba4\ub2c8\ucf00\uc774\uc158\uc744 \ucc98\ub9ac\ud560 \ubbf8\uad6d \ub300\ub9ac\uc778\uc744 \uc9c0\uc815\ud558\uc5ec \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uace0 \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc9c0\uc5f0\uc744 \ubc29\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \uc911\uc694\ud55c \ud1b5\uc9c0\ub97c \ub204\ub77d\ud558\uba74 \ubc30\uc1a1 \uac70\ubd80 \ubc0f \uaddc\uc81c \uc870\uce58\uac00 \ucd08\ub798\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uacf5\uc2dd \ubbf8\uad6d \ub300\ub9ac\uc778\uc73c\ub85c\uc11c FDA \ubb38\uc758\uc5d0 \uc2e0\uc18d\ud558\uac8c \ub300\uc751\ud558\uace0, \uc870\uc0ac\ub97c \uc548\ub0b4\ud558\uba70, \uc6d0\ud65c\ud55c \uc0ac\uc5c5 \uc6b4\uc601\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. FDA\uc5d0\uc11c \uc778\uc815\ud55c \ubbf8\uad6d \ub300\ub9ac\uc778\uc73c\ub85c\uc11c \uc218\ucc9c \uac1c\uc758 \uae30\uc5c5\uc774 \uaddc\uc815 \uc900\uc218\ub97c \uc720\uc9c0\ud558\uace0 \ubd88\ud544\uc694\ud55c \uc704\ud5d8\uc744 \ud53c\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud574 \uc654\uc2b5\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;\ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-registration%2Fmedical-devices%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-2&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li class=\"active\">2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53770&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/strong><\/h4>\n<p>\ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ud558\uae30 \uc804\uc5d0 \ub9e4\ub144 \uc2dc\uc124\uc744 \ub4f1\ub85d\ud558\uace0 FDA\uc5d0 \uae30\uae30\ub97c \ub098\uc5f4\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ub2e8\uacc4\ub97c \uac74\ub108\ub6f0\uba74 \uac12\ube44\uc2fc \uc218\uc785 \uac70\ubd80 \ubc0f \uaddc\uc815 \uc900\uc218 \uacbd\uace0\uac00 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uadc0\ud558\uc758 \ub4f1\ub85d \ubc0f \ubaa9\ub85d\uc774 \uc815\ud655\ud558\uace0 \uc815\uc2dc\uc5d0 \uc644\ub8cc\ub418\ub3c4\ub85d \ubcf4\uc7a5\ud558\uace0, \uc5f0\ub840 \uac31\uc2e0\uc744 \uad00\ub9ac\ud558\uba70, FDA \uc218\uc218\ub8cc \uc9c0\uae09\uc744 \ucc98\ub9ac\ud558\uc5ec \ub9c8\uac10\uc77c\uc744 \ub193\uce58\uc9c0 \uc54a\ub3c4\ub85d \ud569\ub2c8\ub2e4. 20\ub144 \uc774\uc0c1\uc758 \uacbd\ud5d8\uacfc \uc218\ucc9c \uac74\uc758 \uc131\uacf5\uc801\uc778 \ub4f1\ub85d\uc744 \ud1b5\ud574 \uaddc\uc815 \uc900\uc218\ub97c \uac04\uc18c\ud654\ud569\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;FDA\uc5d0 \ub4f1\ub85d&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-registration%2Fmedical-devices%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-3&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li class=\"active\">3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53780&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/strong><\/h4>\n<p>\uace0\uc720 \uae30\uae30 \uc2dd\ubcc4\uc790(UDI)\ub294 \ucd94\uc801 \ubc0f \ud658\uc790 \uc548\uc804\uc744 \uc704\ud574 \ud544\uc218\uc785\ub2c8\ub2e4. \ub204\ub77d\ub418\uac70\ub098 \ubd80\uc815\ud655\ud55c UDI \ub370\uc774\ud130\ub294 \uaddc\uc815 \uc900\uc218 \uc704\ubc18, \uacf5\uae09\ub9dd \uc911\ub2e8 \ubc0f \uc2dc\uc7a5 \ucca0\uc218\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uae30\uae30\uc758 UDI \uc694\uad6c \uc0ac\ud56d\uc744 \uacb0\uc815\ud558\uace0, \ud3ec\ub9f7\uc744 \uc9c0\uc815\ud558\uc5ec FDA\uc5d0 \ub370\uc774\ud130\ub97c \uc81c\ucd9c\ud558\uba70, \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4. FDA\uc758 UDI \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc804\ubb38 \uc9c0\uc2dd\uc744 \ubc14\ud0d5\uc73c\ub85c 3,500\uac1c \uc774\uc0c1\uc758 \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac\uac00 \uc694\uad6c \uc0ac\ud56d\uc744 \uc6d0\ud65c\ud558\uac8c \ud0d0\uc0c9\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;UDI \uc900\uc218 \ubcf4\uc7a5&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-gudid%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-4&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li class=\"active\">4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53790&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/strong><\/h4>\n<p>\uc7a5\uce58 \ub77c\ubca8\uc740 \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uad6c\ub958 \ubc0f \uc81c\ud488 \ubcf4\ub958\ub97c \ubc29\uc9c0\ud558\uae30 \uc704\ud574 100% FDA\ub97c \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \ub204\ub77d\ub41c \uc815\ubcf4, \uc798\ubabb\ub41c \ud615\uc2dd \ub610\ub294 \uc624\ud574\uc758 \uc18c\uc9c0\uac00 \uc788\ub294 \ud074\ub808\uc784\uc740 \ubc30\uc1a1 \uac70\ubd80 \ubc0f \uaddc\uc81c \ucc98\ubc8c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\uc758 \ub77c\ubca8\ub9c1 \uc804\ubb38\uac00\ub294 \uadc0\uc0ac\uc758 \ub77c\ubca8\uc744 \uac80\ud1a0\ud558\uc5ec \uaddc\uc815 \uc900\uc218\ub97c \ud655\uc778\ud558\uace0, \uc801\uc808\ud55c UDI \ud615\uc2dd\uc744 \ubcf4\uc7a5\ud558\uba70, \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud558\uae30 \uc804\uc5d0 \uc7a0\uc7ac\uc801 \uc704\ubc18\uc744 \ud45c\uc2dc\ud569\ub2c8\ub2e4. FDA \ub77c\ubca8\ub9c1 \uaddc\uc815\uc5d0 \ub300\ud55c \uc2ec\uce35\uc801\uc778 \uc804\ubb38 \uc9c0\uc2dd\uc744 \ubc14\ud0d5\uc73c\ub85c \uace0\uac1d\uc774 \uc62c\ubc14\ub974\uac8c \uc791\uc5c5\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;\ub77c\ubca8 \uac80\ud1a0 \ubc1b\uae30&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Flabel-ingredients-review%2F%23meddev|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-5&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li class=\"active\">5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53799&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/strong><\/h4>\n<p>FDA\ub294 \uc774\uc0c1\ubc18\uc751\uc744 \uc801\uc2dc\uc5d0 \ubcf4\uace0\ud558\ub3c4\ub85d \uc694\uad6c\ud558\uba70 \ub9c8\uac10\uc77c\uc744 \ub193\uce58\uac70\ub098 \ubd80\uc815\ud655\ud55c \ub370\uc774\ud130\ub97c \uc81c\ucd9c\ud558\uba74 \uacbd\uace0 \uc11c\uc2e0, \ubbfc\uc0ac\uc0c1 \ubc8c\uae08, \uc81c\ud488 \ub9ac\ucf5c \ubc0f \uc7a0\uc7ac\uc801 \ubc95\uc801 \uc870\uce58\ub97c \ud3ec\ud568\ud55c \uc2ec\uac01\ud55c \ucc98\ubc8c\uc744 \ubc1b\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c(eMDR) \ubcf4\uace0\uc11c\uc758 \ud615\uc2dd\uc744 \uc62c\ubc14\ub974\uac8c \uc9c0\uc815\ud558\uace0 FDA\uc758 NextGen ESG\uc5d0 \uc81c\ucd9c\ud558\uba70 \uaddc\uc81c \uc77c\uc815\uc5d0 \ub530\ub77c \uc81c\ucd9c\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uc218\ucc9c \uac74\uc758 \uc131\uacf5\uc801\uc778 eMDR \uc81c\ucd9c\uc744 \ud1b5\ud574 \ud68c\uc0ac\ub294 \uc9c0\uc5f0\uc744 \ubc29\uc9c0\ud558\uace0 \uaddc\uc815\uc744 \uc900\uc218\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;eMDR \uc81c\ucd9c&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Fadverse-event-reporting%2Femdr%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-6&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li class=\"active\">6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li>7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53809&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/strong><\/h4>\n<p>FDA \uad6c\ub958 \ubc0f \uc218\uc785 \uacbd\uace0\ub294 \uacf5\uae09\ub9dd\uc744 \uc911\ub2e8\uc2dc\ucf1c \uc7ac\uc815\uc801 \uc190\uc2e4, \ubc30\uc1a1 \uc9c0\uc5f0 \ubc0f \uc7a0\uc7ac\uc801 \ubc95\uc801 \uc870\uce58\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\ud488\uc774 \uad6d\uacbd\uc5d0\uc11c \ud640\ub529\ub418\ub294 \uacbd\uc6b0 \uc2e0\uc18d\ud55c \uc870\uce58\uac00 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uad6c\ub958\uc758 \uc6d0\uc778\uc744 \ud30c\uc545\ud558\uace0, \uaddc\uc815 \uc900\uc218 \ubb38\uc11c\ub97c \uc900\ube44\ud558\uba70, FDA\uc640 \ud611\ub825\ud558\uc5ec \uac00\ub2a5\ud55c \ud55c \ube68\ub9ac \uc81c\ud488\uc744 \ucd9c\uc2dc\ud569\ub2c8\ub2e4. Import Alert \ubaa9\ub85d\uc5d0\uc11c \ud68c\uc0ac\ub97c \uc81c\uac70\ud55c \uacac\uc2e4\ud55c \uc2e4\uc801\uc744 \ubc14\ud0d5\uc73c\ub85c \uc2dc\uc7a5 \uc811\uadfc\uc131\uc744 \ube60\ub974\uac8c \ud68c\ubcf5\ud560 \uc218 \uc788\ub3c4\ub85d \ub3c4\uc640\ub4dc\ub9bd\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;\uac00\uc838\uc624\uae30 \uacbd\uace0 \ud574\uacb0&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Fimport-alerts-dwpe%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=&#8221;compliance-roadmap-copy step-7&#8243;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;]\n<ul class=\"compliance-roadmap d-block d-lg-none\">\n<li>1\ub2e8\uacc4: \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815<\/li>\n<li>2\ub2e8\uacc4: \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d \ubc0f \uc7a5\uce58 \ubaa9\ub85d \ubc1b\uae30<\/li>\n<li>3\ub2e8\uacc4: UDI \uc900\uc218 \ubc0f GUDID \uc81c\ucd9c \ud655\uc778<\/li>\n<li>4\ub2e8\uacc4: \uc758\ub8cc \uae30\uae30 \ub77c\ubca8 FDA \uc900\uc218 \ubc1b\uae30<\/li>\n<li>5\ub2e8\uacc4: \uc804\uc790 \uc758\ub8cc\uae30\uae30 \ubcf4\uace0\uc11c\ub97c \uc62c\ubc14\ub974\uac8c \uc81c\ucd9c<\/li>\n<li>6\ub2e8\uacc4: \uc218\uc785 \uacbd\ubcf4 \ubc0f FDA \uad6c\ub958\ub97c \uc2e0\uc18d\ud558\uac8c \ud574\uacb0<\/li>\n<li class=\"active\">7\ub2e8\uacc4: \ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/li>\n<\/ul>\n[\/vc_column_text][vc_single_image image=&#8221;53818&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; el_class=&#8221;d-block d-lg-none&#8221;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"step-subheader\"><strong>\ub9c8\uc2a4\ud130 \ud30c\uc77c\ub85c \uc911\uc694 \ub370\uc774\ud130 \uc81c\ucd9c<\/strong><\/h4>\n<p>\uc758\ub8cc \uae30\uae30 \ub9c8\uc2a4\ud130 \ud30c\uc77c(MAF)\uc744 \uc0ac\uc6a9\ud558\uba74 \ub3c5\uc810 \ub370\uc774\ud130\ub97c \uae30\ubc00\ub85c \uc720\uc9c0\ud558\uba74\uc11c \uc911\uc694\ud55c \uc81c\ud488 \uc815\ubcf4\ub97c FDA\uc5d0 \uc81c\ucd9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. MAF\uac00 \uc5c6\uc73c\uba74 \uaddc\uc81c \uc81c\ucd9c \uc911\uc5d0 \uc0ac\uc5c5 \ud30c\ud2b8\ub108 \ub610\ub294 \uacbd\uc7c1\uc5c5\uccb4\uc5d0 \uc601\uc5c5 \ube44\ubc00\uc744 \uacf5\uac1c\ud574\uc57c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 FDA \uc2b9\uc778 \ud615\uc2dd\uc73c\ub85c MAF\ub97c \uc900\ube44, \uc81c\ucd9c \ubc0f \uad00\ub9ac\ud569\ub2c8\ub2e4. \ub2f9\uc0ac\ub294 ISO 27001\uc744 \uc900\uc218\ud558\ub294 \ubcf4\uc548 \ud504\ub85c\uc138\uc2a4\ub97c \uc0ac\uc6a9\ud558\uc5ec MAF\ub97c \uc800\uc7a5, \ubcf4\ud638 \ubc0f \uc804\uc1a1\ud558\uc5ec \ucd5c\uace0 \uc218\uc900\uc758 \ub370\uc774\ud130 \ubcf4\uc548 \ubc0f \uae30\ubc00\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4. 3,500\uac1c \uc774\uc0c1\uc758 \uae30\uc5c5\uc774 FDA \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uba74\uc11c \ud601\uc2e0\uc744 \uc548\uc804\ud558\uac8c \uc9c0\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;\ub9c8\uc2a4\ud130 \ud30c\uc77c \uc81c\ucd9c&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Fmaster-files%2F%23maf|&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][\/vc_section][vc_section css=&#8221;.vc_custom_1744037702192{padding-top: 0px !important;}&#8221;][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743770224217{background-color: #FFFFFF !important;}&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;7\/12&#8243;][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-start text-primary-700 mb-mobile-32&#8243;]\n<h2>\uc758\ub8cc\uae30\uae30 \uc124\ub9bd \ud5c8\uac00(MDEL)\ub97c \ud1b5\ud574 \uce90\ub098\ub2e4\ub85c \ud655\uc7a5<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221;]\uce90\ub098\ub2e4\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \uc218\uc785 \ub610\ub294 \uc720\ud1b5\ud558\ub824\ub294 \ud68c\uc0ac\uc5d0\uac8c\ub294 \uc758\ub8cc\uae30\uae30 \uc124\ub9bd \ud5c8\uac00(MDEL)\uac00 \ud544\uc218\uc785\ub2c8\ub2e4. \ud558\ub098\uac00 \uc5c6\uc73c\uba74 \uc81c\ud488\uc744 \ud569\ubc95\uc801\uc73c\ub85c \ud310\ub9e4\ud560 \uc218 \uc5c6\uc2b5\ub2c8\ub2e4. <\/p>\n<p>Registrar Corp\ub294 \uae30\uae30\ub97c \ubd84\ub958\ud558\uace0, MDEL \uc2e0\uccad\uc11c\ub97c \uc900\ube44 \ubc0f \uc81c\ucd9c\ud558\uace0, \uac31\uc2e0\uc744 \uad00\ub9ac\ud558\uc5ec \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uce90\ub098\ub2e4 \ubcf4\uac74\ubd80\uc758 \uad11\ubc94\uc704\ud55c \uc804\ubb38 \uc9c0\uc2dd\uc744 \ubc14\ud0d5\uc73c\ub85c \uce90\ub098\ub2e4\ub85c\uc758 \ud655\uc7a5\uc744 \uc6a9\uc774\ud558\uac8c \ud569\ub2c8\ub2e4.[\/vc_column_text][vc_btn title=&#8221;MDEL \uc2dc\uc791\ud558\uae30&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Fhealth-canada%2F|&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;5\/12&#8243;][vc_single_image image=&#8221;51102&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;&#8221;][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;78px&#8221;][vc_separator css=&#8221;&#8221; el_class=&#8221;mb-mobile-32&#8243;][vc_empty_space height=&#8221;54px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>\ud3b8\ub9ac\ud55c \uc628\ub77c\uc778 \uc758\ub8cc \uae30\uae30 \uaddc\uc815 \uc900\uc218 \uad50\uc721<\/h2>\n[\/vc_column_text][vc_empty_space height=&#8221;28px&#8221;][vc_row_inner][vc_column_inner width=&#8221;5\/12&#8243;][vc_single_image image=&#8221;53829&#8243; img_size=&#8221;full&#8221; alignment=&#8221;right&#8221; css=&#8221;&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;7\/12&#8243;][vc_column_text css=&#8221;&#8221;]\uc628\ub77c\uc778 \uad50\uc721\uc744 \ud1b5\ud574 FDA \ubc0f \uae00\ub85c\ubc8c \uaddc\uc81c \ud45c\uc900\uc744 \uc900\uc218\ud569\ub2c8\ub2e4. <\/p>\n<p>\uc804\ubb38\uac00 \uc8fc\ub3c4 \uacfc\uc815\uc744 \ud1b5\ud574 \uc778\uc99d\uc744 \ubc1b\uc740 30,000\uba85 \uc774\uc0c1\uc758 \uc804\ubb38\uac00\ub4e4\uacfc \ud568\uaed8\ud558\uc2ed\uc2dc\uc624. \uc5b8\uc81c \uc5b4\ub514\uc11c\ub098 \ucd5c\uace0\uc758 \uc5c5\uacc4 \uac15\uc0ac\ub85c\ubd80\ud130 \ubc30\uc6b0\uace0 \uad50\uc721\uc5d0 \uc561\uc138\uc2a4\ud558\uc2ed\uc2dc\uc624.[\/vc_column_text][vc_btn title=&#8221;\uad50\uc721 \uc0b4\ud3b4\ubcf4\uae30&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;blue&#8221; size=&#8221;lg&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fcompliance-training%2Fmedical-devices%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; el_class=&#8221;red-blue-bg-blocks&#8221;][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743774875937{background-color: #001C3A !important;}&#8221;][vc_column][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-neutral-000 mb-mobile-32&#8243;]\n<h2>\ub354 \ube60\ub978 \uc2dc\uc7a5 \uc9c4\ucd9c<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-000&#8243;]\n<p style=\"text-align: center; color: #fff;\">FDA \uaddc\uc815 \uc900\uc218\ub294 \ubcf5\uc7a1\ud560 \uc218 \uc788\uc9c0\ub9cc \ud63c\uc790\uc11c \ud574\uacb0\ud560 \ud544\uc694\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. Registrar Corp\ub294 \ubaa8\ub4e0 \ub2e8\uacc4\uac00 \uc62c\ubc14\ub974\uac8c \ucc98\ub9ac\ub418\ub3c4\ub85d \ubcf4\uc7a5\ud558\ubbc0\ub85c \uc548\uc2ec\ud558\uace0 \uc2dc\uc791\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n[\/vc_column_text][vc_btn title=&#8221;\uc9c0\uae08 \uc2dc\uc791\ud558\uae30&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; align=&#8221;center&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;get-started-today&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-registration%2Fmedical-devices%2F|&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743771105032{background-color: #FFFFFF !important;}&#8221;][vc_column][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>\uc54c\uace0 \uacc4\uc2ed\uc2dc\uc624<\/h2>\n[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div id=\"mpc_post-16a34467e6e384\" class=\"mpc-single-post mpc-init mpc-transition mpc-overlay--fade mpc-item--fade mpc-layout--style_1 \"><div onclick=\"\" class=\"mpc-post\"><div class=\"mpc-post__wrapper\"><div class=\"mpc-post__thumbnail\" data-mpc_src=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2024\/06\/Class-I-Medical-Device-1024x576.jpg\" data-mpc_link=\"https:\/\/www.registrarcorp.com\/blog\/medical-devices\/510k-premarket\/class-i-medical-device\/\"><div class=\"mpc-post__overlay mpc-transition\"><div class=\"mpc-post--vertical-wrap\"><div class=\"mpc-post--vertical\" data-mpc_link=\"https:\/\/www.registrarcorp.com\/blog\/medical-devices\/510k-premarket\/class-i-medical-device\/\"><a href=\"https:\/\/www.registrarcorp.com\/blog\/medical-devices\/510k-premarket\/class-i-medical-device\/\" title=\"Read more about How Does a Class I Medical Device Differ from Class II &#038; III\" class=\"mpc-icon-anchor\"><\/a><a href=\"https:\/\/www.registrarcorp.com\/wp-content\/uploads\/2024\/06\/Class-I-Medical-Device.jpg\" title=\"How Does a Class I Medical Device Differ from Class II &#038; III\" class=\"mpc-lightbox mpc-icon-anchor mpc-magnific-popup\"><\/a><div class=\"mpc-post__content mpc-transition\"><h3 class=\"mpc-post__heading mpc-transition mpc-text-overflow\"><a href=\"https:\/\/www.registrarcorp.com\/blog\/medical-devices\/510k-premarket\/class-i-medical-device\/\" title=\"How Does a Class I Medical Device Differ from Class II &#038; III\">How Does a Class I Medical Device Differ from Class II &#038; III<\/a><\/h3><\/div><\/div><\/div><\/div><\/div><div class=\"mpc-post__content mpc-transition\"><h3 class=\"mpc-post__heading mpc-transition mpc-text-overflow\"><a href=\"https:\/\/www.registrarcorp.com\/blog\/medical-devices\/510k-premarket\/class-i-medical-device\/\" title=\"How Does a Class I Medical Device Differ from Class II &#038; III\">How Does a Class I Medical Device Differ from Class II &#038; III<\/a><\/h3><\/div><\/div><\/div><\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]\n<h4 class=\"blog-subheader\"><strong>\ube14\ub85c\uadf8<\/strong><\/h4>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221;]FDA \uaddc\uc815, \uae00\ub85c\ubc8c \uaddc\uc815 \uc900\uc218 \uc5c5\ub370\uc774\ud2b8, \uc804\ubb38\uac00 \ud301 \ub4f1\uc5d0 \ub300\ud55c \ucd5c\uc2e0 \uc778\uc0ac\uc774\ud2b8\ub294 \ube14\ub85c\uadf8\ub97c \ucc38\uc870\ud558\uc2ed\uc2dc\uc624.[\/vc_column_text][vc_btn title=&#8221;\ubaa8\ub450 \ubcf4\uae30&#8221; style=&#8221;classic&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;view-all-btn&#8221; link=&#8221;url:https%3A%2F%2Fwww.registrarcorp.com%2Fko%2Fservices%2Ffda-registration%2Fmedical-devices%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743771267703{padding-top: 50px !important;padding-bottom: 50px !important;background-color: #EEF6FB !important;}&#8221; el_class=&#8221;faq-accordion-section&#8221;][vc_column][vc_empty_space][vc_column_text css=&#8221;&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>FDA \uc758\ub8cc \uae30\uae30 \uaddc\uc815 \uc900\uc218\ub97c \uc704\ud55c FAQ<\/h2>\n[\/vc_column_text][vc_empty_space][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;1&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; el_class=&#8221;accordion&#8221;][vc_tta_section title=&#8221;FDA \uc124\ub9bd \ub4f1\ub85d\uc774\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?&#8221; tab_id=&#8221;faq1&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4, \ucd08\uae30 \uc218\uc785\uc5c5\uccb4 \ubc0f \uae30\ud0c0 \ud2b9\uc815 \uc2dc\uc124\uc740 FDA\uc5d0 \uc2dc\uc124\uc744 \ub4f1\ub85d\ud574\uc57c \ud569\ub2c8\ub2e4. \ub4f1\ub85d\uc740 \uc5f0\ub840 \uc694\uac74\uc774\uba70 \ud68c\uc0ac\ub294 \uaddc\uc815 \uc900\uc218 \ubb38\uc81c\ub97c \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \uc790\uc2e0\uc758 \uc815\ubcf4\uac00 \ucd5c\uc2e0 \uc0c1\ud0dc\uc778\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;FDA\uc5d0 \uc124\ub9bd\uc744 \ub4f1\ub85d\ud574\uc57c \ud558\ub294 \uc0ac\ub78c\uc740 \ub204\uad6c\uc785\ub2c8\uae4c?&#8221; tab_id=&#8221;faq2&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ud560 \uc758\ub8cc \uae30\uae30\uc758 \uc0dd\uc0b0, \uc7ac\ud3ec\uc7a5, \uc7ac\ub77c\ubca8\ub9c1 \ub610\ub294 \uc218\uc785\uacfc \uad00\ub828\ub41c \ubaa8\ub4e0 \uc2dc\uc124\uc740 \ubc18\ub4dc\uc2dc \ub4f1\ub85d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \ubbf8\uad6d\uc73c\ub85c \uae30\uae30\ub97c \uc218\ucd9c\ud558\ub294 \uc678\uad6d \uc81c\uc870\uc5c5\uccb4\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uc678\uad6d \uc758\ub8cc\uae30\uae30 \ud68c\uc0ac\uc758 \uacf5\uc2dd \ubbf8\uad6d \ub300\ub9ac\uc778\uc758 \uc5ed\ud560\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?&#8221; tab_id=&#8221;faq3&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ud558\ub294 \uc678\uad6d \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac\ub294 \uacf5\uc2dd \ubbf8\uad6d \ub300\ub9ac\uc778\uc744 \uc9c0\uc815\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ub300\ub9ac\uc778\uc740 FDA\uc640 \uc678\uad6d \ud68c\uc0ac \uac04\uc758 \uc5f0\ub77d \ub2f4\ub2f9\uc790 \uc5ed\ud560\uc744 \ud558\uba70 \uaddc\uc81c \ucee4\ubba4\ub2c8\ucf00\uc774\uc158, \ub4f1\ub85d \uad00\ub828 \uc9c8\ubb38 \ubc0f \uae34\uae09 \uc6b0\ub824\uc0ac\ud56d\uc744 \ucc98\ub9ac\ud569\ub2c8\ub2e4.[\/vc_column_text][vc_column_text][\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uc758\ub8cc\uae30\uae30 \ubaa9\ub85d\uc774\ub780 \ubb34\uc5c7\uc774\uba70 \uc65c \uc911\uc694\ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;faq4&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc640 \uc218\uc785\uc5c5\uccb4\ub294 \ubbf8\uad6d\uc5d0\uc11c \uc2dc\ud310\ud558\ub294 \uac01 \uae30\uae30\ub97c FDA\uc5d0 \ub098\uc5f4\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ubaa9\ub85d\uc740 \uae30\uae30, \uae30\uae30\uc758 \uc6a9\ub3c4 \ubc0f \uae30\uae30 \uaddc\uc815 \uc900\uc218\ub97c \ub2f4\ub2f9\ud558\ub294 \ud68c\uc0ac\uc5d0 \ub300\ud55c \ud22c\uba85\uc131\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;FDA\ub294 \uc758\ub8cc\uae30\uae30\ub97c \uc5b4\ub5bb\uac8c \ubd84\ub958\ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;faq5&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]FDA\ub294 \uc704\ud5d8 \uc218\uc900 \ubc0f \uaddc\uc81c \uc694\uac74\uc5d0 \ub530\ub77c \uc758\ub8cc\uae30\uae30\ub97c \uc138 \uac00\uc9c0 \ubd84\ub958\ub85c \ubd84\ub958\ud569\ub2c8\ub2e4.<\/p>\n<ul>\n<li><strong>\ub4f1\uae09 I(\uc800\uc704\ud5d8):<\/strong> \uc77c\ubc18\uc801\uc778 \ud1b5\uc81c\uac00 \ud544\uc694\ud560 \uc218 \uc788\uc9c0\ub9cc \ucd9c\uc2dc \uc804 \ud1b5\ubcf4\uc5d0\uc11c \uba74\uc81c\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\ub4f1\uae09 II(\uc911\ub4f1\ub3c4 \uc704\ud5d8):<\/strong> \uc77c\ubc18\uc801\uc73c\ub85c \uc774\ubbf8 \uc2b9\uc778\ub41c \uae30\uae30\uc640 \ub3d9\ub4f1\ud568\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud574 <strong>510(k) \ud5c8\uac00<\/strong>\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/li>\n<li><strong>III\ub4f1\uae09(\uace0\uc704\ud5d8):<\/strong> \uc548\uc804\uc131\uacfc \ud6a8\uacfc\ub97c \uc785\uc99d\ud558\uae30 \uc704\ud55c \uc784\uc0c1\uc2dc\ud5d8\uc744 \ud3ec\ud568\ud558\uc5ec <strong>\uc2dc\ud310 \uc804 \uc2b9\uc778(PMA)<\/strong>\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uc758\ub8cc \uae30\uae30\uc5d0 \ub300\ud55c \uc62c\ubc14\ub978 \ubd84\ub958\ub97c \uc5b4\ub5bb\uac8c \uacb0\uc815\ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016778132-1359bc43-3369&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\uae30\uae30 \ubd84\ub958\ub294 \uc0ac\uc6a9 \ubaa9\uc801, \uc704\ud5d8 \uc218\uc900 \ubc0f \uae30\uc874 FDA \uc2b9\uc778 \uc81c\ud488\uacfc\uc758 \uc720\uc0ac\uc131\uacfc \uac19\uc740 \uc694\uc778\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. \ud68c\uc0ac\ub294 <strong>FDA \uc81c\ud488 \ubd84\ub958 \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub97c<\/strong> \ucc38\uc870\ud558\uac70\ub098 FDA \uc9c0\uce68\uc5d0 \ub300\ud55c <strong>513(g) \uc694\uccad\uc744<\/strong> \uc81c\ucd9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uace0\uc720 \uae30\uae30 \uc2dd\ubcc4\uc790(UDI)\ub780 \ubb34\uc5c7\uc774\uba70 \ub204\uac00 \uc774\ub97c \ud544\uc694\ub85c \ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777943-8d5e467a-f339&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<strong>UDI<\/strong>\ub294 \ucd94\uc801\uc131\uacfc \uc548\uc804\uc131\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\uae30 \uc704\ud574 \uc758\ub8cc\uae30\uae30\uc5d0 \ud560\ub2f9\ub41c \uace0\uc720\ud55c \uc601\uc22b\uc790 \ucf54\ub4dc\uc785\ub2c8\ub2e4. \ub300\ubd80\ubd84\uc758 \uae30\uae30\uc5d0\ub294 \ub77c\ubca8\uacfc \ud3ec\uc7a5\uc5d0 UDI\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud558\uba70, \ud574\ub2f9 \uc815\ubcf4\ub294 <strong>\uae00\ub85c\ubc8c \uace0\uc720 \uae30\uae30 \uc2dd\ubcc4 \ub370\uc774\ud130\ubca0\uc774\uc2a4(GUDID)\uc5d0 \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;GUDID\uc5d0 \uc815\ubcf4\ub97c \uc81c\ucd9c\ud558\ub294 \ubc29\ubc95\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777784-44222cda-8913&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc640 \ub77c\ubca8\ub7ec\ub294 FDA\uc758 <strong>\uae00\ub85c\ubc8c \uace0\uc720 \uae30\uae30 \uc2dd\ubcc4 \ub370\uc774\ud130\ubca0\uc774\uc2a4(GUDID)\uc5d0 UDI \uad00\ub828 \ub370\uc774\ud130\ub97c \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong> \uc81c\ucd9c\ubb3c\uc740 \ud2b9\uc815 \ud615\uc2dd \ubc0f \ucf58\ud150\uce20 \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud558\uba70 \ud68c\uc0ac\ub294 GUDID \uacc4\uc815\uc744 \uc124\uc815\ud574\uc57c \ud569\ub2c8\ub2e4.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;eMDR\uc774\ub780 \ubb34\uc5c7\uc774\uba70 \ub204\uac00 \uc900\uc218\ud574\uc57c \ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777595-ce49d7a0-18ce&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<span class=\"TextRun SCXW156574888 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156574888 BCX0\"><\/span><\/span><span class=\"TextRun MacChromeBold SCXW156574888 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156574888 BCX0\">\uc804\uc790 <strong>\uc758\ub8cc\uae30\uae30 \ubcf4\uace0(<\/strong><\/span><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW156574888 BCX0\">eMDR<\/span><span class=\"NormalTextRun SCXW156574888 BCX0\">)<\/span><\/strong><\/span><span class=\"TextRun SCXW156574888 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156574888 BCX0\"> \uc2dc\uc2a4\ud15c\uc740 \uc774\uc0c1\ubc18\uc751 \ubc0f \uc624\uc791\ub3d9 \ubcf4\uace0\uc11c\ub97c \uc81c\ucd9c\ud558\uae30 \uc704\ud55c FDA\uc758 \ud50c\ub7ab\ud3fc<\/span><span class=\"NormalTextRun SCXW156574888 BCX0\">\uc785\ub2c8\ub2e4.<span class=\"NormalTextRun SCXW156574888 BCX0\"><\/span> \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4, \uc218\uc785\uc5c5\uccb4 \ubc0f \uc0ac\uc6a9\uc790 \uc2dc\uc124\uc740 eMDR \uc694\uac74\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4<\/span>.<span class=\"NormalTextRun SCXW156574888 BCX0\"><\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW156574888 BCX0\"><\/span><span class=\"NormalTextRun SCXW156574888 BCX0\"> <\/span><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\ub0b4 \uc758\ub8cc\uae30\uae30\uac00 FDA\uc5d0 \uc758\ud574 \uad6c\uae08\ub418\uba74 \uc5b4\ub5bb\uac8c \ud574\uc57c \ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777414-6ee0c8fb-b742&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<span class=\"TextRun SCXW233471976 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW233471976 BCX0\">\ub77c\ubca8<\/span> \uc624\ub958, \ub4f1\ub85d \ub204\ub77d \ub610\ub294 \uae30\ud0c0 \uaddc\uc815 \ubbf8\uc900\uc218 \ubb38\uc81c\ub85c <span class=\"NormalTextRun SCXW233471976 BCX0\">\uc778\ud574 \uae30\uae30\uac00 \uc5b5\ub958\ub420 \uc218 <\/span>\uc788\uc2b5\ub2c8\ub2e4.<span class=\"NormalTextRun SCXW233471976 BCX0\">  \uae30\uc5c5\uc740 \uc218\uc785\uc744 \uc7ac\uc2dc\ub3c4\ud558\uae30 \uc804\uc5d0 FDA\uc758 \uad6c\ub958 \ud1b5\uc9c0\ub97c \uac80\ud1a0\ud558\uace0, <\/span>\ubb38\uc81c\ub97c <span class=\"NormalTextRun SCXW233471976 BCX0\">\uc2dd\ubcc4\ud558\uace0<\/span>, \uaddc\uc81c \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud55c \uc2dc\uc815 \uc870\uce58\ub97c \ucde8\ud574\uc57c \ud569\ub2c8\ub2e4.<span class=\"NormalTextRun SCXW233471976 BCX0\"> <\/span><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;FDA \uc218\uc785 \uacbd\uace0\ub780 \ubb34\uc5c7\uc774\uba70, \ub0b4 \uc0ac\uc5c5\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777229-0a759e88-9b17&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<span class=\"TextRun MacChromeBold SCXW46141081 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW46141081 BCX0\">\uc218\uc785 \uacbd\uace0<\/span><\/span><span class=\"TextRun SCXW46141081 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW46141081 BCX0\">\ub294 <\/span><\/span><span class=\"TextRun SCXW46141081 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW46141081 BCX0\"> \uc81c\ud488 \ub610\ub294 \ud68c\uc0ac\uac00 FDA\uc5d0 \uc758\ud574 \ubc18\ubcf5\ub418\ub294 \uaddc\uc815\uc900\uc218 \ubb38\uc81c\uc5d0 \ub300\ud574 \ud50c\ub798\uadf8\uac00 \uc9c0\uc815\ub418\uc5b4 \uad6d\uacbd\uc5d0\uc11c \uc790\ub3d9 \uad6c\ub958\ub97c \ucd08\ub798\ud588\uc74c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. Import Alert\ub97c \uc0ac\uc6a9\ud558\ub294 \uae30\uc5c5\uc740 \ubc1c\uc1a1\ubb3c\uc744 \ucd9c\ud558\ud558\uae30 \uc804\uc5d0 \ubbf8\ud574\uacb0 \uaddc\uc81c \ubb38\uc81c\ub97c \ud574\uacb0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/span><span class=\"EOP SCXW46141081 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;510(k) \ud504\ub85c\uc138\uc2a4\ub294 \ubb34\uc5c7\uc774\uba70 \uc5b8\uc81c \ud544\uc694\ud569\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016777040-48e84151-392f&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]\ud68c\uc0ac\uac00 \ucd9c\uc2dc \uc804 \ud1b5\uc9c0\uc5d0\uc11c \uba74\uc81c\ub418\uc9c0 \uc54a\ub294 II \ub4f1\uae09 \uae30\uae30\ub97c \ub3c4\uc785\ud558\ub294 \uacbd\uc6b0 <span class=\"TextRun SCXW238585404 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW238585404 BCX0\"><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW238585404 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW238585404 BCX0\">510(k) \uc81c\ucd9c<\/span><\/span><\/strong>\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<span class=\"TextRun SCXW238585404 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW238585404 BCX0\"> <\/span><span class=\"NormalTextRun SCXW238585404 BCX0\"><\/span><span class=\"NormalTextRun SCXW238585404 BCX0\">  \uc774 \uc81c\ucd9c<\/span>\ubb3c\uc740 \uc7a5\uce58\uac00 \uc774\ubbf8 \uc2b9\uc778\ub41c \uc7a5\uce58\uc640 \u201c\uc2e4\uc9c8\uc801\uc73c\ub85c \ub3d9\ub4f1\u201d\ud558\ub2e4\ub294 \uac83\uc744 <span class=\"NormalTextRun SCXW238585404 BCX0\">\ubcf4\uc5ec\uc90d\ub2c8\ub2e4<\/span>.<span class=\"NormalTextRun SCXW238585404 BCX0\"> <\/span><\/span><span class=\"EOP SCXW238585404 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;De Novo \uc81c\ucd9c\ubb3c\uc774\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016776840-ab87c843-ae3f&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<span class=\"TextRun SCXW148321255 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148321255 BCX0\"><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW148321255 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148321255 BCX0\">De Novo \uacbd\ub85c<\/span><\/span><\/strong><span class=\"TextRun SCXW148321255 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148321255 BCX0\">\ub294 \uae30\uae30\uac00 \uae30\uc874\uc5d0 \ub3d9\ub4f1\ud558\uc9c0 \uc54a\uc9c0\ub9cc \uc704\ud5d8\uc774 \ub0ae\uc740 \uac83\uc73c\ub85c \uac04\uc8fc\ub418\ub294 \uacbd\uc6b0\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \uc774 \ud504\ub85c\uc138\uc2a4\ub97c \ud1b5\ud574 FDA\ub294 \uc0c8\ub85c\uc6b4 \uae30\uae30\ub97c \ubd84\ub958\ud558\uace0 \uaddc\uc81c \uc694\uac74\uc744 \uc218\ub9bd\ud560 \uc218 <\/span>\uc788\uc2b5\ub2c8\ub2e4.<span class=\"NormalTextRun SCXW148321255 BCX0\"><\/span><span class=\"NormalTextRun SCXW148321255 BCX0\"> <\/span><\/span><span class=\"EOP SCXW148321255 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\ucd9c\uc2dc \uc804 \uc2b9\uc778(PMA)\uc774\ub780 \ubb34\uc5c7\uc774\uba70, 510(k)\uc640 \uc5b4\ub5bb\uac8c \ub2e4\ub985\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016776583-14b26f87-fe37&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<strong><span class=\"TextRun MacChromeBold SCXW58311528 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58311528 BCX0\">PMA<\/span><\/span><\/strong><span class=\"TextRun SCXW58311528 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58311528 BCX0\">\ub294 \uc704\ud5d8\uc774 \ub192\uc740 III \ub4f1\uae09 \uae30\uae30\uc5d0 \ud544\uc694\ud569\ub2c8\ub2e4. \uae30\uc874 \uae30\uae30\uc640 \ub3d9\ub4f1\ud568\uc744 \ubcf4\uc5ec\uc8fc\ub294 <strong><span class=\"TextRun MacChromeBold SCXW58311528 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58311528 BCX0\">510(k) \ud504\ub85c\uc138\uc2a4<\/span><\/span><\/strong>\uc640 \ub2ec\ub9ac<\/span><\/span>, PMA\ub294 \uc548\uc804\uc131\uacfc \uc720\ud6a8\uc131\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud574 \uad11\ubc94\uc704\ud55c \uc784\uc0c1 \uac80\uc0ac\uc640 FDA \uac80\ud1a0\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4.<span class=\"TextRun SCXW58311528 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58311528 BCX0\"><\/span><\/span><span class=\"EOP SCXW58311528 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uc815\ubcf4\uc790\uc720\ubc95(FOIA)\uc774\ub780 \ubb34\uc5c7\uc774\uba70, \uc6b0\ub9ac \ud68c\uc0ac\uc5d0 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\uae4c?&#8221; tab_id=&#8221;1744016775955-c2c3ab54-fc3b&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text css=&#8221;&#8221;]<strong><span class=\"TextRun MacChromeBold SCXW179932056 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW179932056 BCX0\">FOIA<\/span><\/span><\/strong>\uc5d0 <span class=\"TextRun SCXW179932056 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW179932056 BCX0\">\ub530\ub77c <\/span><\/span><span class=\"TextRun SCXW179932056 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW179932056 BCX0\">\ud68c\uc0ac\ub294 \uacfc\uac70 \uc7a5\uce58 \uc2b9\uc778, \uac80\uc0ac \ubcf4\uace0\uc11c \ubc0f \uc9d1\ud589 \uc870\uce58\ub97c \ud3ec\ud568\ud55c FDA \uae30\ub85d\uc5d0 \ub300\ud55c \uc561\uc138\uc2a4\ub97c \uc694\uccad\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \uaddc\uc81c \uacc4\ud68d\uc5d0 \ub300\ud55c \uadc0\uc911\ud55c \ud1b5\ucc30\ub825\uc744 \uc81c\uacf5\ud560 \uc218 <\/span>\uc788\uc2b5\ub2c8\ub2e4.<span class=\"NormalTextRun SCXW179932056 BCX0\"><\/span><span class=\"NormalTextRun SCXW179932056 BCX0\"> <\/span><\/span><span class=\"EOP SCXW179932056 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\uc758\ub8cc\uae30\uae30 \ub9c8\uc2a4\ud130 \ud30c\uc77c(MDMF)\uc774\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?&#8221; 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