{"id":75202,"date":"2023-06-01T06:18:28","date_gmt":"2023-06-01T06:18:28","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/tuan-thu-thiet-bi-phat-xa-buc-xa\/"},"modified":"2026-08-11T13:46:38","modified_gmt":"2026-08-11T13:46:38","slug":"tuan-thu-thiet-bi-phat-xa-buc-xa","status":"publish","type":"page","link":"https:\/\/staging.registrarcorp.com\/vi\/tuan-thu-thiet-bi-phat-xa-buc-xa\/","title":{"rendered":"Tu\u00e2n th\u1ee7 Thi\u1ebft b\u1ecb Ph\u00e1t x\u1ea1 B\u1ee9c x\u1ea1"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1726505182147{padding-top: 50px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;vertical-text-align hero-section&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;col-txt-center&#8221;][vc_column_text css=&#8221;&#8221;]\n<h1 class=\"banner-title\"><strong>C\u1ea7n tr\u1ee3 gi\u00fap \u0111\u1ec3 nh\u1eadn<span style=\"color: #0081ff;\"> Tu\u00e2n th\u1ee7 Thi\u1ebft b\u1ecb \u0110i\u1ec7n t\u1eed Ph\u00e1t x\u1ea1 B\u1ee9c x\u1ea1 (RED)?<\/span><\/strong><\/h1>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h4=&#8221;Montserrat&#8221; fnt_size_h4=&#8221;24px&#8221;]Vi\u1ec7c nh\u1eadp kh\u1ea9u RED \u0111i k\u00e8m v\u1edbi r\u1ea5t nhi\u1ec1u quy tr\u00ecnh v\u00e0 th\u1ee7 t\u1ee5c gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh, t\u1eeb vi\u1ec7c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ea1i di\u1ec7n \u0111\u1ecba ph\u01b0\u01a1ng \u0111\u1ec3 c\u00f3 \u0111\u01b0\u1ee3c S\u1ed1 \u0111\u0103ng k\u00fd c\u1ee7a FDA v\u00e0 g\u1eedi b\u00e1o c\u00e1o s\u1ea3n ph\u1ea9m. \u0110\u00f3 l\u00e0 n\u01a1i Registrar Corp b\u01b0\u1edbc v\u00e0o. V\u1edbi h\u01a1n 20 n\u0103m kinh nghi\u1ec7m h\u01b0\u1edbng d\u1eabn c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t trong v\u00e0 ngo\u00e0i n\u01b0\u1edbc th\u00f4ng qua vi\u1ec7c tu\u00e2n th\u1ee7 FDA, ch\u00fang t\u00f4i c\u00f3 th\u1ec3 gi\u00fap \u0111\u01b0a s\u1ea3n ph\u1ea9m c\u1ee7a b\u1ea1n \u0111\u1ebfn th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.[\/vc_column_text][vc_btn title=&#8221;Li\u00ean h\u1ec7 v\u1edbi Nh\u00e0 \u0111\u0103ng k\u00fd Corp h\u00f4m nay&#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;.vc_custom_1687529950084{padding-top: 20px !important;}&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn btnTextBold&#8221; link=&#8221;url:%23formSection|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;75208&#8243; img_size=&#8221;large&#8221; alignment=&#8221;right&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1685610609084{padding-top: 50px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;vertical-text-align&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;75204&#8243; img_size=&#8221;610&#215;426&#8243;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;col-txt-center&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;32px&#8221; fnt_family_h2=&#8221;Montserrat&#8221; fnt_size_h2=&#8221;32px&#8221; fnt_family_h3=&#8221;Montserrat&#8221;]\n<p style=\"font-weight: 600;\">Nh\u00e0 \u0111\u0103ng k\u00fd Corp RED Services<\/p>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18px&#8221; fnt_family_h5=&#8221;Montserrat&#8221; fnt_size_h5=&#8221;18px&#8221;]Ch\u00fang t\u00f4i \u1edf \u0111\u00e2y \u0111\u1ec3 tr\u1edf th\u00e0nh nh\u00f3m tu\u00e2n th\u1ee7 t\u1ea1i \u0111\u1ecba ph\u01b0\u01a1ng c\u1ee7a b\u1ea1n \u0111\u1ec3 b\u1ea1n c\u00f3 th\u1ec3 \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh c\u1ee7a RED. C\u00e1c d\u1ecbch v\u1ee5 c\u1ee7a ch\u00fang t\u00f4i d\u00e0nh cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t, nh\u00e0 l\u1eafp r\u00e1p v\u00e0 nh\u00e0 nh\u1eadp kh\u1ea9u RED bao g\u1ed3m:[\/vc_column_text][vc_column_text]\n<div class=\"p-main-list\">\n<div class=\"p-list-icon\"><img decoding=\"async\" class=\"alignnone size-full wp-image-3814\" src=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services1.png\" alt=\"\" width=\"42\" height=\"42\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services1.png 84w, https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services1-150x150.png 150w, https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services1-600x600.png 600w\" sizes=\"(max-width: 42px) 100vw, 42px\" \/><\/div>\n<p>\u0110\u1ea1i l\u00fd \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh t\u1ea1i Hoa K\u1ef3 cho D\u1ecbch v\u1ee5 Quy tr\u00ecnh<\/p>\n<\/div>\n<div class=\"p-main-list\">\n<div class=\"p-list-icon\"><img decoding=\"async\" class=\"alignnone size-full wp-image-3806\" src=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services2.png\" alt=\"\" width=\"44\" height=\"44\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services2.png 88w, https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services2-150x150.png 150w, https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services2-600x600.png 600w\" sizes=\"(max-width: 44px) 100vw, 44px\" \/><\/div>\n<p>Chu\u1ea9n b\u1ecb v\u00e0 g\u1eedi B\u00e1o c\u00e1o th\u01b0\u1eddng ni\u00ean v\u1ec1 s\u1ea3n ph\u1ea9m v\u00e0 b\u00e1o c\u00e1o th\u01b0\u1eddng ni\u00ean<\/p>\n<\/div>\n<div class=\"p-main-list\">\n<div class=\"p-list-icon\"><img decoding=\"async\" width=\"104\" height=\"86\" class=\"alignnone size-full wp-image-3835\" src=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2023\/06\/red-services3-1.png\" alt=\"\"><\/div>\n<p>H\u1ed7 tr\u1ee3 S\u1ed1 \u0111\u0103ng k\u00fd FDA<\/p>\n<\/div>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1685362047546{background-color: #ffffff !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h2=&#8221;Montserrat&#8221; fnt_family_h3=&#8221;Montserrat&#8221; fnt_size_h3=&#8221;24px&#8221;]\n<p style=\"font-weight: 600;\">\u0110\u1ea1i l\u00fd Hoa K\u1ef3<\/p>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18px&#8221; fnt_family_h5=&#8221;Montserrat&#8221; fnt_size_h5=&#8221;18px&#8221;]\u0110\u1ea1i l\u00fd D\u1ecbch v\u1ee5 X\u1eed l\u00fd t\u1ea1i Hoa K\u1ef3 \u0111\u00f3ng vai tr\u00f2 l\u00e0 \u0111\u1ea1i di\u1ec7n c\u1ee7a c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t n\u01b0\u1edbc ngo\u00e0i b\u1eb1ng c\u00e1ch nh\u1eadn b\u1ea5t k\u1ef3 t\u00e0i li\u1ec7u ph\u00e1p l\u00fd n\u00e0o c\u1ee7a Hoa K\u1ef3 \u0111\u01b0\u1ee3c cung c\u1ea5p cho nh\u00e0 s\u1ea3n xu\u1ea5t. V\u1edbi Registrar Corp, b\u1ea1n s\u1ebd nh\u1eadn \u0111\u01b0\u1ee3c m\u1ed9t \u0111\u1ea1i l\u00fd chuy\u00ean d\u1ee5ng, ng\u01b0\u1eddi s\u1ebd nhanh ch\u00f3ng chuy\u1ec3n ti\u1ebfp b\u1ea5t k\u1ef3 t\u00e0i li\u1ec7u n\u00e0o trong tr\u01b0\u1eddng h\u1ee3p h\u00e0nh \u0111\u1ed9ng ph\u00e1p l\u00fd, \u0111\u1ec3 b\u1ea1n c\u00f3 th\u1ec3 tr\u1ea3 l\u1eddi k\u1ecbp th\u1eddi.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;food-rt-col&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h2=&#8221;Montserrat&#8221; fnt_family_h3=&#8221;Montserrat&#8221; fnt_size_h3=&#8221;24px&#8221;]\n<p style=\"font-weight: 600;\">S\u1ed1 \u0111\u0103ng k\u00fd FDA<\/p>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18px&#8221; fnt_family_h5=&#8221;Montserrat&#8221; fnt_size_h5=&#8221;18px&#8221;]S\u1ed1 \u0111\u0103ng k\u00fd FDA c\u1ee7a b\u1ea1n, ho\u1eb7c s\u1ed1 nh\u1eadn d\u1ea1ng b\u00e1o c\u00e1o duy nh\u1ea5t, s\u1ebd \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111\u1ec3 \u0111i\u1ec1n v\u00e0o c\u00e1c t\u00e0i li\u1ec7u nh\u1eadp kh\u1ea9u t\u1ea1i c\u1ea3ng nh\u1eadp c\u1ea3nh. Ch\u00fang t\u00f4i c\u00f3 th\u1ec3 l\u00e0m vi\u1ec7c v\u1edbi b\u1ea1n \u0111\u1ec3 c\u00f3 \u0111\u01b0\u1ee3c S\u1ed1 \u0111\u0103ng k\u00fd FDA c\u1ee7a b\u1ea1n v\u00e0 h\u01b0\u1edbng d\u1eabn b\u1ea1n qua quy tr\u00ecnh nh\u1eadp kh\u1ea9u m\u1ed9t c\u00e1ch nhanh ch\u00f3ng v\u00e0 hi\u1ec7u qu\u1ea3.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1685603355338{background-color: #ffffff !important;}&#8221; el_class=&#8221;vertical-text-align&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h2=&#8221;Montserrat&#8221; fnt_family_h3=&#8221;Montserrat&#8221; fnt_size_h3=&#8221;24px&#8221;]\n<p style=\"font-weight: 600;\">G\u1eedi b\u00e1o c\u00e1o s\u1ea3n ph\u1ea9m<\/p>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18px&#8221; fnt_family_h5=&#8221;Montserrat&#8221; fnt_size_h5=&#8221;18px&#8221;]Tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n RED, b\u1ea1n ph\u1ea3i g\u1eedi B\u00e1o c\u00e1o s\u1ea3n ph\u1ea9m t\u1edbi Trung t\u00e2m thi\u1ebft b\u1ecb v\u00e0 s\u1ee9c kh\u1ecfe ph\u00f3ng x\u1ea1 (CDRH) c\u1ee7a FDA. B\u1ea1n c\u0169ng c\u1ea7n ph\u1ea3i t\u1ea1o B\u00e1o c\u00e1o th\u01b0\u1eddng ni\u00ean m\u1ed7i n\u0103m s\u1ea3n ph\u1ea9m c\u1ee7a b\u1ea1n c\u00f3 m\u1eb7t tr\u00ean th\u1ecb tr\u01b0\u1eddng. \u0110\u1ed9i ng\u0169 chuy\u00ean gia c\u1ee7a Registrar Corp c\u00f3 th\u1ec3 gi\u00fap b\u1ea1n duy tr\u00ec h\u1ed3 s\u01a1 RED v\u00e0 t\u1ed5 ch\u1ee9c, chu\u1ea9n b\u1ecb v\u00e0 g\u1eedi b\u00e1o c\u00e1o s\u1ea3n ph\u1ea9m th\u01b0\u1eddng xuy\u00ean.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;food-rt-col&#8221;][vc_single_image image=&#8221;75203&#8243; img_size=&#8221;463&#215;246&#8243; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1685610582693{padding-bottom: 100px !important;background-color: #ffffff !important;}&#8221;][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1685362239351{padding-top: 0px !important;}&#8221;][vc_btn title=&#8221;\u0110\u0103ng k\u00fd S\u1ed1 \u0111\u0103ng k\u00fd&#8221; 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img_size=&#8221;medium&#8221; alignment=&#8221;right&#8221; css=&#8221;.vc_custom_1700046407325{margin-bottom: -105px !important;}&#8221; el_class=&#8221;hide-row&#8221;][vc_custom_heading text=&#8221;C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p&#8221; font_container=&#8221;tag:h2|font_size:40px|text_align:left|color:%23003873&#8243; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221; css=&#8221;.vc_custom_1700046521506{border-bottom-width: 0.5px !important;padding-bottom: 20px !important;border-bottom-color: #000000 !important;border-bottom-style: solid !important;}&#8221;][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;][vc_tta_section title=&#8221;S\u1ea3n ph\u1ea9m n\u00e0o \u0111\u01b0\u1ee3c coi l\u00e0 Thi\u1ebft b\u1ecb \u0110i\u1ec7n t\u1eed Ph\u00e1t x\u1ea1 B\u1ee9c x\u1ea1 (RED)?&#8221; tab_id=&#8221;1685604840761-3c3da900-1f52&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text]RED \u0111\u01b0\u1ee3c FDA \u0111\u1ecbnh ngh\u0129a l\u00e0 b\u1ea5t k\u1ef3 s\u1ea3n ph\u1ea9m n\u00e0o c\u00f3 ch\u1ee9a m\u1ea1ch \u0111i\u1ec7n t\u1eed v\u00e0 t\u1ea1o ra b\u1ea5t k\u1ef3 lo\u1ea1i b\u1ee9c x\u1ea1 n\u00e0o, ch\u1eb3ng h\u1ea1n nh\u01b0 b\u1ee9c x\u1ea1 X (tia X), vi s\u00f3ng, s\u00f3ng v\u00f4 tuy\u1ebfn (t\u1ea7n s\u1ed1 v\u00f4 tuy\u1ebfn (RF)), laser, \u00e1nh s\u00e1ng nh\u00ecn th\u1ea5y, \u00e2m thanh, si\u00eau \u00e2m ho\u1eb7c tia c\u1ef1c t\u00edm. M\u1ed9t s\u1ed1 v\u00ed d\u1ee5 v\u1ec1 RED bao g\u1ed3m h\u1ec7 th\u1ed1ng X-quang ch\u1ea9n \u0111o\u00e1n, s\u1ea3n ph\u1ea9m laser, m\u00e0n tr\u00ecnh di\u1ec5n \u00e1nh s\u00e1ng laser v\u00e0 l\u00f2 vi s\u00f3ng.<\/p>\n<p>B\u1ea1n c\u00f3 th\u1ec3 t\u00ecm th\u1ea5y c\u00e1c thu\u1eadt ng\u1eef ph\u00e1p l\u00fd v\u00e0 \u0111\u1ecbnh ngh\u0129a v\u1ec1 RED t\u1ea1i <a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2010-title21\/html\/USCODE-2010-title21-chap9-subchapV-partC-sec360ii.htm\" target=\"_blank\" rel=\"noopener\">\u0111\u00e2y<\/a>.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;T\u00f4i c\u00f3 b\u1eaft bu\u1ed9c ph\u1ea3i duy tr\u00ec h\u1ed3 s\u01a1 v\u00e0 g\u1eedi b\u00e1o c\u00e1o cho c\u00e1c s\u1ea3n ph\u1ea9m \u0110\u1ece kh\u00f4ng?&#8221; tab_id=&#8221;1685604840786-46b71773-a396&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text]C\u00f3, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i duy tr\u00ec h\u1ed3 s\u01a1 v\u1ec1 RED c\u1ee7a h\u1ecd v\u00e0 g\u1eedi b\u00e1o c\u00e1o cho Trung t\u00e2m Thi\u1ebft b\u1ecb v\u00e0 S\u1ee9c kh\u1ecfe Ph\u00f3ng x\u1ea1 (CDRH) c\u1ee7a FDA. C\u00f3 th\u1ec3 t\u00ecm th\u1ea5y c\u00e1c y\u00eau c\u1ea7u v\u00e0 th\u00f4ng tin c\u1ee5 th\u1ec3 v\u1ec1 b\u00e1o c\u00e1o v\u00e0 l\u01b0u gi\u1eef h\u1ed3 s\u01a1 trong B\u1ea3ng 1 c\u1ee7a <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=1002\" target=\"_blank\" rel=\"noopener\">Ti\u00eau \u0111\u1ec1 21 c\u1ee7a B\u1ed9 lu\u1eadt Quy \u0111\u1ecbnh Li\u00ean bang<\/a> v\u00e0 tr\u00ean <a href=\"https:\/\/www.fda.gov\/radiation-emitting-products\/getting-radiation-emitting-product-market-frequently-asked-questions\/submitting-reports-and-requirements-maintaining-records-radiation\" target=\"_blank\" rel=\"noopener\">trang web c\u1ee7a FDA<\/a>.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Khi n\u00e0o t\u00f4i ph\u1ea3i g\u1eedi th\u00f4ng tin s\u1ea3n ph\u1ea9m v\u00e0 b\u00e1o c\u00e1o th\u01b0\u1eddng ni\u00ean?&#8221; tab_id=&#8221;1685604840811-081bf594-48aa&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text]S\u1ea3n ph\u1ea9m c\u00f3 m\u00e0u \u0110\u1ece, c\u00e1c b\u00e1o c\u00e1o b\u1ed5 sung ho\u1eb7c vi\u1ebft t\u1eaft ph\u1ea3i \u0111\u01b0\u1ee3c n\u1ed9p tr\u01b0\u1edbc khi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u v\u00e0o Hoa K\u1ef3 ho\u1eb7c tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n s\u1ea3n ph\u1ea9m qua c\u00e1c d\u00f2ng ti\u1ec3u bang n\u1ebfu l\u00e0 s\u1ea3n ph\u1ea9m n\u1ed9i \u0111\u1ecba. B\u00e1o c\u00e1o cho s\u1ea3n ph\u1ea9m nh\u1eadp kh\u1ea9u ph\u1ea3i \u0111\u01b0\u1ee3c g\u1eedi \u00edt nh\u1ea5t m\u1ed9t th\u00e1ng tr\u01b0\u1edbc khi giao h\u00e0ng.<\/p>\n<p>B\u00e1o c\u00e1o RED h\u00e0ng n\u0103m s\u1ebd \u0111\u01b0\u1ee3c g\u1eedi \u0111\u1ebfn h\u1ea1n h\u00e0ng n\u0103m v\u00e0o ng\u00e0y 1 th\u00e1ng 9 v\u00e0 s\u1ebd bao g\u1ed3m vi\u1ec7c s\u1ea3n xu\u1ea5t cho Hoa K\u1ef3 t\u1eeb ng\u00e0y 1 th\u00e1ng 7 c\u1ee7a n\u0103m tr\u01b0\u1edbc \u0111\u1ebfn ng\u00e0y 30 th\u00e1ng 6 c\u1ee7a n\u0103m hi\u1ec7n t\u1ea1i.<\/p>\n<p>Vi\u1ec7c g\u1eedi b\u00e1o c\u00e1o s\u1edbm cho ph\u00e9p CDRH c\u00f3 th\u1eddi gian li\u00ean h\u1ec7 v\u1edbi b\u1ea1n v\u1ec1 c\u00e1c v\u1ea5n \u0111\u1ec1 ti\u1ec1m \u1ea9n v\u00e0 cung c\u1ea5p x\u00e1c nh\u1eadn th\u01b0 x\u00e1c nh\u1eadn bao g\u1ed3m s\u1ed1 nh\u1eadn d\u1ea1ng duy nh\u1ea5t cho b\u00e1o c\u00e1o c\u1ee7a b\u1ea1n ho\u1eb7c S\u1ed1 \u0111\u0103ng k\u00fd.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;S\u1ed1 \u0111\u0103ng k\u00fd c\u00f3 ngh\u0129a l\u00e0 s\u1ea3n ph\u1ea9m c\u1ee7a t\u00f4i \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t kh\u00f4ng?&#8221; tab_id=&#8221;1685604840838-308ed055-8ebb&#8221; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text]Kh\u00f4ng, S\u1ed1 \u0111\u0103ng k\u00fd c\u1ee7a FDA ch\u1ec9 c\u00f3 ngh\u0129a l\u00e0 b\u00e1o c\u00e1o c\u1ee7a b\u1ea1n \u0111\u00e3 \u0111\u01b0\u1ee3c nh\u1eadn v\u00e0 x\u1eed l\u00fd v\u00e0o c\u01a1 s\u1edf d\u1eef li\u1ec7u c\u1ee7a CDRH Document Control Center (DCC).[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;T\u00f4i c\u00f3 ph\u1ea3i \u0111\u1ee3i th\u01b0 x\u00e1c nh\u1eadn \u0111\u1ec3 g\u1eedi s\u1ea3n ph\u1ea9m c\u1ee7a m\u00ecnh kh\u00f4ng?&#8221; tab_id=&#8221;1685604840864-ced74f40-76b7&#8243; el_class=&#8221;prior-faq-sec&#8221;][vc_column_text]Kh\u00f4ng, nh\u01b0ng b\u1ea1n c\u1ea7n ph\u1ea3i xu\u1ea5t tr\u00ecnh S\u1ed1 \u0111\u0103ng k\u00fd t\u1ea1i c\u1ea3ng nh\u1eadp c\u1ea3nh, n\u1ebfu kh\u00f4ng l\u00f4 h\u00e0ng c\u1ee7a b\u1ea1n s\u1ebd b\u1ecb gi\u1eef l\u1ea1i. Th\u01b0 x\u00e1c nh\u1eadn v\u00e0 S\u1ed1 \u0111\u0103ng k\u00fd \u0111\u01b0\u1ee3c coi l\u00e0 b\u1eb1ng ch\u1ee9ng cho th\u1ea5y CDRH \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o c\u1ee7a b\u1ea1n v\u00e0 c\u00e1c c\u00f4ng ty nh\u1eadp kh\u1ea9u RED s\u1ebd c\u1ea7n bao g\u1ed3m S\u1ed1 \u0111\u0103ng k\u00fd c\u1ee7a h\u1ecd tr\u00ean m\u1eabu x\u00e1c nh\u1eadn nh\u1eadp kh\u1ea9u, <a href=\"https:\/\/www.fda.gov\/about-fda\/reports-manuals-forms\/forms\" target=\"_blank\" rel=\"noopener\">FDA 2877<\/a>.<\/p>\n<p>T\u00f9y thu\u1ed9c v\u00e0o c\u00e1c bi\u1ebfn th\u1ec3 c\u1ee7a m\u1eabu thi\u1ebft b\u1ecb \u0111ang \u0111\u01b0\u1ee3c nh\u1eadp v\u00e0 c\u00f4ng ngh\u1ec7 trong thi\u1ebft b\u1ecb (v\u00ed d\u1ee5: thi\u1ebft b\u1ecb laser v\u00e0 tia X trong m\u1ed9t l\u00f4 h\u00e0ng), b\u1ea1n c\u00f3 th\u1ec3 c\u1ea7n t\u1ea1o hai S\u1ed1 \u0111\u0103ng k\u00fd tr\u1edf l\u00ean t\u1ea1i c\u1ea3ng nh\u1eadp c\u1ea3nh.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1726505182147{padding-top: 50px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;vertical-text-align hero-section&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;col-txt-center&#8221;][vc_column_text css=&#8221;&#8221;] C\u1ea7n tr\u1ee3 gi\u00fap \u0111\u1ec3 nh\u1eadn Tu\u00e2n th\u1ee7 Thi\u1ebft b\u1ecb \u0110i\u1ec7n t\u1eed Ph\u00e1t x\u1ea1 B\u1ee9c x\u1ea1 (RED)? [\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24px&#8221; fnt_family_h4=&#8221;Montserrat&#8221; fnt_size_h4=&#8221;24px&#8221;]Vi\u1ec7c nh\u1eadp kh\u1ea9u RED \u0111i k\u00e8m v\u1edbi r\u1ea5t nhi\u1ec1u quy tr\u00ecnh v\u00e0 th\u1ee7 t\u1ee5c gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh, t\u1eeb vi\u1ec7c<\/p>\n","protected":false},"author":33,"featured_media":0,"parent":75491,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/page-sidebar-none.php","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"class_list":["post-75202","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/75202","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/comments?post=75202"}],"version-history":[{"count":2,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/75202\/revisions"}],"predecessor-version":[{"id":75233,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/75202\/revisions\/75233"}],"up":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/75491"}],"wp:attachment":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media?parent=75202"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}