{"id":1521,"date":"2026-10-23T15:56:34","date_gmt":"2026-10-23T06:56:34","guid":{"rendered":"https:\/\/hansemvietnam.com\/?p=1521"},"modified":"2026-10-23T15:56:34","modified_gmt":"2026-10-23T06:56:34","slug":"fda-medical-device-webinar-ifu-and-labeling","status":"publish","type":"post","link":"https:\/\/hansemvietnam.com\/vi\/blog\/fda-medical-device-webinar-ifu-and-labeling\/","title":{"rendered":"H\u1ed9i th\u1ea3o tr\u1ef1c tuy\u1ebfn v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 quy \u0111\u1ecbnh FDA: \nH\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) v\u00e0 D\u00e1n nh\u00e3n (Data Labeling)"},"content":{"rendered":"<div class=\"para_first\">\n    <div class=\"blog_scription_wrap\">\n    <p>Hansem Global ph\u1ed1i h\u1ee3p c\u00f9ng Amin Wasserman Gurnani (AWG), m\u1ed9t h\u00e3ng lu\u1eadt t\u1ea1i Hoa K\u1ef3 chuy\u00ean v\u1ec1 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a FDA, t\u1ed5 ch\u1ee9c h\u1ed9i th\u1ea3o tr\u1ef1c tuy\u1ebfn v\u1ec1 nh\u1eefng \u0111i\u1ec1u doanh nghi\u1ec7p c\u1ea7n chu\u1ea9n b\u1ecb \u0111\u1ec3 \u0111\u01b0a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0o th\u1ecb tr\u01b0\u1eddng M\u1ef9. V\u1edbi ch\u1ee7 \u0111\u1ec1 \u201cL\u00e0m \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u: \u0110\u01b0a thi\u1ebft b\u1ecb y t\u1ebf ra th\u1ecb tr\u01b0\u1eddng M\u1ef9 \u0111\u00fang quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt\u201d, h\u1ed9i th\u1ea3o k\u00e9o d\u00e0i m\u1ed9t gi\u1edd s\u1ebd k\u1ebft h\u1ee3p g\u00f3c nh\u00ecn ph\u00e1p l\u00fd v\u1edbi chuy\u00ean m\u00f4n x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u. AWG s\u1ebd gi\u1edbi thi\u1ec7u nh\u1eefng y\u00eau c\u1ea7u ph\u00e1p l\u00fd quan tr\u1ecdng c\u1ee7a FDA, c\u00f2n Hansem Global s\u1ebd l\u00e0m r\u00f5 c\u00e1ch chuy\u1ec3n c\u00e1c y\u00eau c\u1ea7u \u0111\u00f3 th\u00e0nh n\u1ed9i dung c\u1ee5 th\u1ec3 trong t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) v\u00e0 d\u00e1n nh\u00e3n thi\u1ebft b\u1ecb.<\/p>\n    <div class=\"blog_scription\">\n            <p class=\"scripted\">\n                Scripted by<br>\n                <span class=\"corporate\">Hansem Vi\u1ec7t Nam<\/span>\n            <\/p>\n            <figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/hansemvietnam.com\/wp-content\/themes\/hansemv\/img\/common\/profile_hs_vietnam.png\" alt=\"\" class=\"wp-image-743\"><\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n<div class=\"blog_view_box\">\n    <figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/banner_261023.png\" alt=\"FDA Medical Device Webinar: IFU and Labeling\" class=\"wp-image-743\"><\/figure>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Th\u00f4ng tin h\u1ed9i th\u1ea3o<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>Ng\u00e0y<\/strong><strong><\/strong><\/td><td><strong>Th\u1ee9 Ba, ng\u00e0y 10 th\u00e1ng 11 n\u0103m 2026<\/strong><strong><\/strong><\/td><\/tr><\/thead><tbody><tr><td>Th\u1eddi gian<\/td><td>14:00\u201315:00 gi\u1edd mi\u1ec1n \u0110\u00f4ng Hoa K\u1ef3 (2:00 \u2013 3:00 gi\u1edd Vi\u1ec7t Nam)<\/td><\/tr><tr><td>H\u00ecnh th\u1ee9c<\/td><td>H\u1ed9i th\u1ea3o tr\u1ef1c tuy\u1ebfn tr\u1ef1c ti\u1ebfp (GoToWebinar)<\/td><\/tr><tr><td>\u0110\u01a1n v\u1ecb t\u1ed5 ch\u1ee9c<\/td><td>Amin Wasserman Gurnani (AWG) v\u00e0 Hansem Global<\/td><\/tr><tr><td>\u0110\u0103ng k\u00fd<\/td><td><a href=\"https:\/\/register.gotowebinar.com\/register\/3566545699040380768\" target=\"_blank\" rel=\"noopener\">https:\/\/register.gotowebinar.com\/register\/3566545699040380768<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">V\u00ec sao n\u00ean tham d\u1ef1?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">M\u1ef9 v\u1eabn l\u00e0 m\u1ed9t trong nh\u1eefng th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb y t\u1ebf c\u1ea1nh tranh nh\u1ea5t, \u0111\u1ed3ng th\u1eddi c\u00f3 h\u1ec7 th\u1ed1ng quy \u0111\u1ecbnh qu\u1ea3n l\u00fd ch\u1eb7t ch\u1ebd b\u1eadc nh\u1ea5t. Ngay c\u1ea3 khi s\u1edf h\u1eefu s\u1ea3n ph\u1ea9m ch\u1ea5t l\u01b0\u1ee3ng cao, nhi\u1ec1u doanh nghi\u1ec7p v\u1eabn ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nh\u1eefng ch\u1eadm tr\u1ec5 t\u1ed1n k\u00e9m do h\u1ed3 s\u01a1 t\u00e0i li\u1ec7u ch\u01b0a \u0111\u1ea7y \u0111\u1ee7 ho\u1eb7c hi\u1ec3u ch\u01b0a \u0111\u00fang c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd. D\u00f9 \u0111\u1eb7t tr\u1ee5 s\u1edf t\u1ea1i M\u1ef9 hay n\u01b0\u1edbc ngo\u00e0i, nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ec1u ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00f9ng m\u1ed9t h\u1ec7 th\u1ed1ng y\u00eau c\u1ea7u c\u1ee7a FDA; trong \u0111\u00f3, ghi nh\u00e3n li\u00ean quan \u0111\u1ebfn h\u1ea7u h\u1ebft c\u00e1c y\u00eau c\u1ea7u n\u00e0y.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">H\u1ed9i th\u1ea3o s\u1ebd gi\u1ea3i th\u00edch c\u00e1c y\u00eau c\u1ea7u tr\u1ecdng y\u1ebfu \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng khi n\u00e0o v\u00e0 nh\u01b0 th\u1ebf n\u00e0o, \u0111\u01b0a ra h\u01b0\u1edbng d\u1eabn th\u1ef1c ti\u1ec5n v\u1ec1 th\u1eddi gian tri\u1ec3n khai v\u00e0 r\u1ee7i ro khi c\u01a1 quan qu\u1ea3n l\u00fd th\u1ef1c thi quy \u0111\u1ecbnh, \u0111\u1ed3ng th\u1eddi chia s\u1ebb c\u00e1c gi\u1ea3i ph\u00e1p gi\u00fap gi\u1ea3m thi\u1ec3u nguy c\u01a1 b\u1ecb c\u01a1 quan qu\u1ea3n l\u00fd xem x\u00e9t k\u1ef9.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">N\u1ed9i dung h\u1ed9i th\u1ea3o<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>C\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd c\u1ee7a FDA (AWG)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>H\u1ed3 s\u01a1 n\u1ed9p tr\u01b0\u1edbc khi \u0111\u01b0a thi\u1ebft b\u1ecb y t\u1ebf ra th\u1ecb tr\u01b0\u1eddng, bao g\u1ed3m h\u1ed3 s\u01a1 510(k)<\/li>\n\n\n\n<li>Quy \u0111\u1ecbnh v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMSR)<\/li>\n\n\n\n<li>\u0110\u0103ng k\u00fd c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, kinh doanh v\u00e0 li\u1ec7t k\u00ea thi\u1ebft b\u1ecb<\/li>\n\n\n\n<li>B\u00e1o c\u00e1o v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>X\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u IFU b\u1ea3o \u0111\u1ea3m an to\u00e0n, d\u1ec5 s\u1eed d\u1ee5ng v\u00e0 s\u1eb5n s\u00e0ng \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh (Hansem Global)<br><\/strong>Tr\u01b0\u1edbc khi x\u00e1c \u0111\u1ecbnh nh\u1eefng quy \u0111\u1ecbnh n\u00e0o c\u1ee7a FDA \u00e1p d\u1ee5ng cho t\u00e0i li\u1ec7u IFU, nh\u00e0 s\u1ea3n xu\u1ea5t n\u00ean \u0111\u1eb7t ra m\u1ed9t c\u00e2u h\u1ecfi c\u01a1 b\u1ea3n h\u01a1n: t\u00e0i li\u1ec7u n\u00e0y \u0111\u00e3 th\u1ef1c s\u1ef1 h\u01b0\u1edbng d\u1eabn ng\u01b0\u1eddi d\u00f9ng s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb hi\u1ec7u qu\u1ea3 hay ch\u01b0a? Hansem Global s\u1ebd tr\u00ecnh b\u00e0y c\u00e1c nguy\u00ean t\u1eafc x\u00e2y d\u1ef1ng th\u00f4ng tin h\u01b0\u1edbng d\u1eabn ng\u01b0\u1eddi d\u00f9ng c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng trong m\u1ecdi ng\u00e0nh, bao g\u1ed3m thi\u1ebft k\u1ebf IFU l\u1ea5y ng\u01b0\u1eddi d\u00f9ng l\u00e0m trung t\u00e2m theo IEC\/IEEE 82079-1 v\u00e0 c\u00e1ch truy\u1ec1n \u0111\u1ea1t th\u00f4ng tin an to\u00e0n theo ANSI Z535.6. Ti\u1ebfp \u0111\u00f3, h\u1ed9i th\u1ea3o s\u1ebd l\u00e0m r\u00f5 c\u00e1ch t\u00edch h\u1ee3p c\u00e1c y\u00eau c\u1ea7u ri\u00eang c\u1ee7a FDA d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf, ch\u1eb3ng h\u1ea1n quy \u0111\u1ecbnh ghi nh\u00e3n t\u1ea1i 21 CFR Part 801 v\u00e0 m\u00e3 \u0111\u1ecbnh danh thi\u1ebft b\u1ecb duy nh\u1ea5t (UDI), v\u00e0o t\u00e0i li\u1ec7u IFU.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ai n\u00ean tham d\u1ef1?<br><\/strong>Ch\u01b0\u01a1ng tr\u00ecnh d\u00e0nh cho c\u00e1c doanh nghi\u1ec7p thi\u1ebft b\u1ecb y t\u1ebf v\u1eeba v\u00e0 nh\u1ecf \u0111ang t\u00ecm ki\u1ebfm c\u00e1i nh\u00ecn t\u1ed5ng quan r\u00f5 r\u00e0ng, thi\u1ebft th\u1ef1c v\u1ec1 vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh FDA khi \u0111\u01b0a s\u1ea3n ph\u1ea9m v\u00e0o th\u1ecb tr\u01b0\u1eddng M\u1ef9. H\u1ed9i th\u1ea3o \u0111\u1eb7c bi\u1ec7t ph\u00f9 h\u1ee3p v\u1edbi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Doanh nghi\u1ec7p chu\u1ea9n b\u1ecb l\u1ea7n \u0111\u1ea7u ra m\u1eaft s\u1ea3n ph\u1ea9m t\u1ea1i M\u1ef9 ho\u1eb7c m\u1edf r\u1ed9ng ho\u1ea1t \u0111\u1ed9ng sang th\u1ecb tr\u01b0\u1eddng n\u00e0y<\/li>\n\n\n\n<li>Chuy\u00ean gia ph\u1ee5 tr\u00e1ch ph\u00e1p ch\u1ebf, tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng<\/li>\n\n\n\n<li>B\u1ed9 ph\u1eadn x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt v\u00e0 ghi nh\u00e3n<\/li>\n\n\n\n<li>L\u00e3nh \u0111\u1ea1o doanh nghi\u1ec7p mu\u1ed1n r\u00e0 so\u00e1t, \u0111\u00e1nh gi\u00e1 t\u00ednh v\u1eefng ch\u1eafc c\u1ee7a chi\u1ebfn l\u01b0\u1ee3c ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng M\u1ef9 hi\u1ec7n t\u1ea1i<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ngo\u00e0i l\u00e3nh th\u1ed5 M\u1ef9, trong \u0111\u00f3 c\u00f3 doanh nghi\u1ec7p t\u1ea1i ch\u00e2u \u00c1 v\u00e0 ch\u00e2u \u00c2u, c\u0169ng s\u1ebd hi\u1ec3u r\u00f5 h\u01a1n t\u00e1c \u0111\u1ed9ng c\u1ee7a c\u00e1c y\u00eau c\u1ea7u FDA \u0111\u1ed1i v\u1edbi c\u1ea3 h\u1ed3 s\u01a1 n\u1ed9p cho c\u01a1 quan qu\u1ea3n l\u00fd l\u1eabn t\u00e0i li\u1ec7u s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Di\u1ec5n gi\u1ea3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Neil O\u2019Flaherty | Lu\u1eadt s\u01b0 th\u00e0nh vi\u00ean, Amin Wasserman Gurnani<br><\/strong>Neil c\u00f3 h\u01a1n 36 n\u0103m kinh nghi\u1ec7m h\u00e0nh ngh\u1ec1 lu\u1eadt, \u0111\u1ea1i di\u1ec7n cho c\u00e1c doanh nghi\u1ec7p thi\u1ebft b\u1ecb y t\u1ebf. \u00d4ng t\u01b0 v\u1ea5n cho kh\u00e1ch h\u00e0ng v\u1ec1 thi\u1ebft b\u1ecb lo\u1ea1i I, II v\u00e0 III trong t\u1ea5t c\u1ea3 c\u00e1c giai \u0111o\u1ea1n, t\u1eeb chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 tr\u01b0\u1edbc khi \u0111\u01b0a s\u1ea3n ph\u1ea9m ra th\u1ecb tr\u01b0\u1eddng \u0111\u1ebfn ho\u1ea1t \u0111\u1ed9ng th\u01b0\u01a1ng m\u1ea1i, v\u1edbi kh\u00e1ch h\u00e0ng t\u1eeb c\u00e1c t\u1eadp \u0111o\u00e0n \u0111a qu\u1ed1c gia \u0111\u1ebfn doanh nghi\u1ec7p kh\u1edfi nghi\u1ec7p.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Brian Cho | Gi\u00e1m \u0111\u1ed1c \u0111i\u1ec1u h\u00e0nh, PMP, Hansem Global<br><\/strong>Brian h\u1ed7 tr\u1ee3 c\u00e1c doanh nghi\u1ec7p thi\u1ebft b\u1ecb y t\u1ebf x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u r\u00f5 r\u00e0ng, ch\u00ednh x\u00e1c v\u00e0 s\u1eb5n s\u00e0ng cho c\u00f4ng t\u00e1c b\u1ea3n \u0111\u1ecba h\u00f3a t\u1ea1i th\u1ecb tr\u01b0\u1eddng M\u1ef9 c\u0169ng nh\u01b0 qu\u1ed1c t\u1ebf. \u00d4ng mang \u0111\u1ebfn g\u00f3c nh\u00ecn th\u1ef1c ti\u1ec5n v\u1ec1 m\u1ed1i li\u00ean h\u1ec7 gi\u1eefa ch\u1ea5t l\u01b0\u1ee3ng t\u00e0i li\u1ec7u, b\u1ea3n \u0111\u1ecba h\u00f3a v\u00e0 c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd trong qu\u00e1 tr\u00ecnh \u0111\u01b0a s\u1ea3n ph\u1ea9m ra th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0110\u0103ng k\u00fd ngay<br><\/strong>S\u1ed1 l\u01b0\u1ee3ng ch\u1ed7 tham d\u1ef1 c\u00f3 h\u1ea1n.<\/br>\nVui l\u00f2ng \u0111\u0103ng k\u00fd gi\u1eef ch\u1ed7 qua li\u00ean k\u1ebft d\u01b0\u1edbi \u0111\u00e2y.<br>\u2022\t\u0110\u0103ng k\u00fd: <a href=\"https:\/\/register.gotowebinar.com\/register\/3566545699040380768\" target=\"_blank\" rel=\"noopener\">https:\/\/register.gotowebinar.com\/register\/3566545699040380768<\/a><br>\u2022\tTrang s\u1ef1 ki\u1ec7n tr\u00ean website AWG: <a href=\"https:\/\/awglaw.com\/events\/how-to-get-it-right-legally-launch-a-medical-device-in-the-u-s\/\" target=\"_blank\" rel=\"noopener\">https:\/\/awglaw.com\/events\/how-to-get-it-right-legally-launch-a-medical-device-in-the-u-s\/<\/a><br>N\u1ebfu doanh nghi\u1ec7p c\u1ee7a b\u1ea1n \u0111ang c\u00f3 k\u1ebf ho\u1ea1ch x\u00e2y d\u1ef1ng, d\u1ecbch thu\u1eadt ho\u1eb7c b\u1ea3n \u0111\u1ecba h\u00f3a t\u00e0i li\u1ec7u IFU cho thi\u1ebft b\u1ecb y t\u1ebf, h\u00e3y li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i. C\u00e1c chuy\u00ean gia ph\u1ee5 tr\u00e1ch t\u1eebng d\u1ecbch v\u1ee5 lu\u00f4n s\u1eb5n s\u00e0ng trao \u0111\u1ed5i v\u00e0 t\u01b0 v\u1ea5n chi ti\u1ebft.<\/p>","protected":false},"excerpt":{"rendered":"<p>Hansem Global ph\u1ed1i h\u1ee3p c\u00f9ng Amin Wasserman Gurnani (AWG), m\u1ed9t h\u00e3ng lu\u1eadt t\u1ea1i Hoa K\u1ef3 chuy\u00ean v\u1ec1 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a FDA, t\u1ed5 ch\u1ee9c h\u1ed9i th\u1ea3o tr\u1ef1c tuy\u1ebfn v\u1ec1 nh\u1eefng \u0111i\u1ec1u doanh nghi\u1ec7p c\u1ea7n chu\u1ea9n b\u1ecb \u0111\u1ec3 \u0111\u01b0a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0o th\u1ecb tr\u01b0\u1eddng M\u1ef9. V\u1edbi ch\u1ee7 \u0111\u1ec1 \u201cL\u00e0m \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u: \u0110\u01b0a thi\u1ebft b\u1ecb y t\u1ebf ra th\u1ecb tr\u01b0\u1eddng M\u1ef9 \u0111\u00fang quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt\u201d, h\u1ed9i th\u1ea3o k\u00e9o d\u00e0i m\u1ed9t gi\u1edd s\u1ebd k\u1ebft h\u1ee3p g\u00f3c nh\u00ecn ph\u00e1p l\u00fd v\u1edbi chuy\u00ean m\u00f4n x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u. AWG s\u1ebd gi\u1edbi thi\u1ec7u nh\u1eefng y\u00eau c\u1ea7u ph\u00e1p l\u00fd quan tr\u1ecdng c\u1ee7a FDA, c\u00f2n Hansem Global s\u1ebd l\u00e0m r\u00f5 c\u00e1ch chuy\u1ec3n c\u00e1c y\u00eau c\u1ea7u \u0111\u00f3 th\u00e0nh n\u1ed9i dung c\u1ee5 th\u1ec3 trong t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) v\u00e0 d\u00e1n nh\u00e3n thi\u1ebft b\u1ecb.<\/p>","protected":false},"author":1,"featured_media":1525,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,1,126],"tags":[200,201,26,204,203,202,206,198,205],"class_list":["post-1521","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-active","category-blog","category-localization","tag-fdacompliance","tag-fdaregulations","tag-hansemglobal","tag-ifu","tag-instructionsforuse","tag-medicaldevicelabeling","tag-medicaldevicelocalization","tag-medicaldevices","tag-medicaldevicewebinar"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.6 - 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