{"id":60009,"date":"2023-10-27T15:44:58","date_gmt":"2023-10-27T06:44:58","guid":{"rendered":"https:\/\/monolith.law\/vi\/?p=60009"},"modified":"2023-11-07T09:13:25","modified_gmt":"2023-11-07T00:13:25","slug":"medical-equipment-regulation","status":"publish","type":"post","link":"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation","title":{"rendered":"Quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf &#8211; \u0110\u1ea1o lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n"},"content":{"rendered":"\n<p>C\u00f3 nhi\u1ec1u lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c nhau. Trong s\u1ed1 \u0111\u00f3, c\u00f3 nh\u1eefng thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 \u1ea3nh h\u01b0\u1edfng l\u1edbn \u0111\u1ebfn c\u01a1 th\u1ec3 v\u00e0 s\u1ee9c kh\u1ecfe c\u1ee7a ch\u00fang ta.<\/p>\n\n\n\n<p>N\u1ebfu qu\u1ea3ng c\u00e1o kh\u00f4ng ph\u00f9 h\u1ee3p v\u1ec1 c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf n\u00e0y \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i, c\u00f3 kh\u1ea3 n\u0103ng ng\u01b0\u1eddi tin v\u00e0o n\u1ed9i dung qu\u1ea3ng c\u00e1o kh\u00f4ng ph\u00f9 h\u1ee3p \u0111\u00f3 s\u1ebd mua v\u00e0 s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb y t\u1ebf, d\u1eabn \u0111\u1ebfn h\u1eadu qu\u1ea3 l\u00e0 g\u00e2y ra thi\u1ec7t h\u1ea1i s\u1ee9c kh\u1ecfe nghi\u00eam tr\u1ecdng.<\/p>\n\n\n\n<p>Do \u0111\u00f3, vi\u1ec7c \u0111\u0103ng t\u1ea3i qu\u1ea3ng c\u00e1o v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong Lu\u1eadt v\u1ec1 \u0110\u1ea3m b\u1ea3o Ch\u1ea5t l\u01b0\u1ee3ng, Hi\u1ec7u qu\u1ea3 v\u00e0 An to\u00e0n c\u1ee7a D\u01b0\u1ee3c ph\u1ea9m, Thi\u1ebft b\u1ecb y t\u1ebf, v.v. (sau \u0111\u00e2y g\u1ecdi l\u00e0 &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf&#8221; c\u1ee7a Nh\u1eadt B\u1ea3n).<\/p>\n\n\n\n<p>V\u00ec v\u1eady, trong b\u00e0i vi\u1ebft n\u00e0y, ch\u00fang t\u00f4i s\u1ebd gi\u1edbi thi\u1ec7u v\u1ec1 quy \u0111\u1ecbnh ph\u00e1p l\u00fd li\u00ean quan \u0111\u1ebfn qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf d\u00e0nh cho nh\u1eefng doanh nghi\u1ec7p \u0111ang c\u00e2n nh\u1eafc vi\u1ec7c \u0111\u0103ng t\u1ea3i qu\u1ea3ng c\u00e1o v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-\u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09 wp-block-embed-\u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"zTySdfRPPU\"><a href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-supplies-law\">Quy \u0111\u1ecbnh ph\u00e1p l\u00fd v\u1ec1 vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thu\u1ed1c: Gi\u1ea3i th\u00edch v\u1ec1 &#8216;Lu\u1eadt thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n&#8217;<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Quy \u0111\u1ecbnh ph\u00e1p l\u00fd v\u1ec1 vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thu\u1ed1c: Gi\u1ea3i th\u00edch v\u1ec1 &#8216;Lu\u1eadt thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n&#8217;&#8221; &#8212; \u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09\" src=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-supplies-law\/embed#?secret=PWtP5hJmI0#?secret=zTySdfRPPU\" data-secret=\"zTySdfRPPU\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-\u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09 wp-block-embed-\u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"u8UBGDQHII\"><a href=\"https:\/\/monolith.law\/vi\/general-corporate\/cbd-ad-pmd-restriction\">Quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o s\u1ea3n ph\u1ea9m CBD l\u00e0 g\u00ec? Lu\u1eadt s\u01b0 gi\u1ea3i th\u00edch m\u1ed1i quan h\u1ec7 v\u1edbi &#8216;Lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217; v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 kh\u00e1c<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o s\u1ea3n ph\u1ea9m CBD l\u00e0 g\u00ec? Lu\u1eadt s\u01b0 gi\u1ea3i th\u00edch m\u1ed1i quan h\u1ec7 v\u1edbi &#8216;Lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217; v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 kh\u00e1c&#8221; &#8212; \u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b5\u30a4\u30c8\uff08\u30d9\u30c8\u30ca\u30e0\u8a9e\uff09\" src=\"https:\/\/monolith.law\/vi\/general-corporate\/cbd-ad-pmd-restriction\/embed#?secret=RzhC0P6WFA#?secret=u8UBGDQHII\" data-secret=\"u8UBGDQHII\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Quy_dinh_ve_quang_cao_thiet_bi_y_te_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban_la_gi\" title=\"Quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?\">Quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Dinh_nghia_phap_ly_ve_thiet_bi_y_te\" title=\"\u0110\u1ecbnh ngh\u0129a ph\u00e1p l\u00fd v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf\">\u0110\u1ecbnh ngh\u0129a ph\u00e1p l\u00fd v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Quy_dinh_ve_bieu_hien_quang_cao_thiet_bi_y_te\" title=\"Quy \u0111\u1ecbnh v\u1ec1 bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf\">Quy \u0111\u1ecbnh v\u1ec1 bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Dinh_nghia_%E2%80%9Cquang_cao%E2%80%9D\" title=\"\u0110\u1ecbnh ngh\u0129a &#8220;qu\u1ea3ng c\u00e1o&#8221;\">\u0110\u1ecbnh ngh\u0129a &#8220;qu\u1ea3ng c\u00e1o&#8221;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Ve_doi_tuong_cua_quy_dinh_quang_cao_thiet_bi_y_te\" title=\"V\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf\">V\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Bieu_hien_nao_la_doi_tuong_cua_quy_dinh\" title=\"Bi\u1ec3u hi\u1ec7n n\u00e0o l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh\">Bi\u1ec3u hi\u1ec7n n\u00e0o l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Ve_viec_cam_quang_cao_phong_dai_vv_lien_quan_den_thiet_bi_y_te_Dieu_66\" title=\"V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf (\u0110i\u1ec1u 66)\">V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf (\u0110i\u1ec1u 66)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Ve_viec_cam_quang_cao_thiet_bi_y_te_truoc_khi_duoc_phe_duyet_Dieu_68\" title=\"V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (\u0110i\u1ec1u 68)\">V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (\u0110i\u1ec1u 68)<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Tong_ket\" title=\"T\u1ed5ng k\u1ebft\">T\u1ed5ng k\u1ebft<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/medical-equipment-regulation\/#Huong_dan_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\" title=\"H\u01b0\u1edbng d\u1eabn c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i\">H\u01b0\u1edbng d\u1eabn c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Quy_dinh_ve_quang_cao_thiet_bi_y_te_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban_la_gi\"><\/span>Quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act), \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf c\u0169ng nh\u01b0 ng\u0103n ch\u1eb7n s\u1ef1 ph\u00e1t sinh v\u00e0 lan r\u1ed9ng c\u1ee7a nh\u1eefng r\u1ee7i ro v\u1ec1 s\u1ee9c kh\u1ecfe do vi\u1ec7c s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb y t\u1ebf, c\u00e1c quy \u0111\u1ecbnh sau \u0111\u00e2y \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng cho vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf:<\/p>\n\n\n\n<ul>\n<li>C\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i (\u0110i\u1ec1u 66)<\/li>\n\n\n\n<li>C\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (\u0110i\u1ec1u 68)<\/li>\n<\/ul>\n\n\n\n<p>D\u01b0\u1edbi \u0111\u00e2y, ch\u00fang t\u00f4i s\u1ebd gi\u1ea3i th\u00edch chi ti\u1ebft v\u1ec1 c\u00e1c quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_phap_ly_ve_thiet_bi_y_te\"><\/span>\u0110\u1ecbnh ngh\u0129a ph\u00e1p l\u00fd v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/Monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation4.jpg\" alt=\"\" class=\"wp-image-45031\" \/><\/figure><\/div>\n\n\n<p>\u0110\u1ecbnh ngh\u0129a v\u1ec1 &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221; \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong \u0110i\u1ec1u 2, Kho\u1ea3n 4 c\u1ee7a &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8221; nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(\u0110\u1ecbnh ngh\u0129a)<br>Trong lu\u1eadt n\u00e0y, &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221; l\u00e0 c\u00e1c m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v. (tr\u1eeb s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, v.v.) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, ho\u1eb7c c\u00f3 m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh.<\/p>\n<\/blockquote>\n\n\n\n<p>T\u1eeb \u0111\u1ecbnh ngh\u0129a tr\u00ean, \u0111\u1ec3 \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221;, c\u1ea7n ph\u1ea3i \u0111\u00e1p \u1ee9ng m\u1ed9t trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau:<\/p>\n\n\n\n<ul>\n<li>\u0110\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt<\/li>\n\n\n\n<li>C\u00f3 m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt<\/li>\n<\/ul>\n\n\n\n<p>L\u01b0u \u00fd r\u1eb1ng, t\u1eeb \u0111\u1ecbnh ngh\u0129a &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221;, c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, v.v. \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb, do \u0111\u00f3, c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, v.v. kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5 c\u1ee5 th\u1ec3 v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf g\u1ea7n g\u0169i v\u1edbi cu\u1ed9c s\u1ed1ng h\u00e0ng ng\u00e0y c\u1ee7a ch\u00fang ta bao g\u1ed3m nhi\u1ec7t k\u1ebf, m\u00e1y \u0111o huy\u1ebft \u00e1p, k\u00ednh \u00e1p tr\u00f2ng, v.v.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, AED c\u0169ng \u0111\u01b0\u1ee3c coi l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Quy_dinh_ve_bieu_hien_quang_cao_thiet_bi_y_te\"><\/span>Quy \u0111\u1ecbnh v\u1ec1 bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/Monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation2.jpg\" alt=\"\" class=\"wp-image-45028\" \/><\/figure><\/div>\n\n\n<p>Quy \u0111\u1ecbnh v\u1ec1 bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0 \u0111\u00e3 n\u00eau tr\u01b0\u1edbc \u0111\u00e2y, qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i v\u00e0 qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh n\u00e0y.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_%E2%80%9Cquang_cao%E2%80%9D\"><\/span>\u0110\u1ecbnh ngh\u0129a &#8220;qu\u1ea3ng c\u00e1o&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n (Ph\u00e1p lu\u1eadt Yakuji), kh\u00f4ng c\u00f3 quy \u0111\u1ecbnh \u0111\u1ecbnh ngh\u0129a v\u1ec1 &#8220;qu\u1ea3ng c\u00e1o&#8221; \u0111\u1ed1i v\u1edbi &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221;.<\/p>\n\n\n\n<p>Tuy nhi\u00ean, thu\u1eadt ng\u1eef &#8220;qu\u1ea3ng c\u00e1o&#8221; \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong c\u00e1c quy \u0111\u1ecbnh c\u1ee7a Ph\u00e1p lu\u1eadt Yakuji, n\u1ebfu kh\u00f4ng bi\u1ebft \u0111i\u1ec1u g\u00ec \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;qu\u1ea3ng c\u00e1o&#8221;, s\u1ebd kh\u00f4ng th\u1ec3 x\u00e1c \u0111\u1ecbnh li\u1ec7u Ph\u00e1p lu\u1eadt Yakuji c\u00f3 \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng hay kh\u00f4ng.<\/p>\n\n\n\n<p>V\u00ec v\u1eady, c\u1ea7n ph\u1ea3i xem x\u00e9t \u00fd ngh\u0129a c\u1ee7a &#8220;qu\u1ea3ng c\u00e1o&#8221;.<\/p>\n\n\n\n<p>V\u1ec1 &#8220;qu\u1ea3ng c\u00e1o&#8221; theo Ph\u00e1p lu\u1eadt Yakuji, c\u00e1c y\u00eau c\u1ea7u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong &#8220;V\u1ec1 vi\u1ec7c \u00e1p d\u1ee5ng qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m, v.v. trong Ph\u00e1p lu\u1eadt Yakuji&#8221; (Th\u00f4ng b\u00e1o s\u1ed1 148 ng\u00e0y 29 th\u00e1ng 9 n\u0103m 1998 (1998) c\u1ee7a C\u1ee5c Gi\u00e1m s\u00e1t v\u00e0 H\u01b0\u1edbng d\u1eabn An to\u00e0n D\u01b0\u1ee3c ph\u1ea9m, B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n g\u1eedi \u0111\u1ebfn c\u00e1c Gi\u00e1m \u0111\u1ed1c S\u1edf Y t\u1ebf c\u1ee7a c\u00e1c t\u1ec9nh, th\u00e0nh ph\u1ed1).<\/p>\n\n\n\n<p>C\u1ee5 th\u1ec3, n\u1ebfu \u0111\u00e1p \u1ee9ng 3 y\u00eau c\u1ea7u sau \u0111\u00e2y, n\u00f3 s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;qu\u1ea3ng c\u00e1o&#8221;:<\/p>\n\n\n\n<ul>\n<li>\u00dd \u0111\u1ecbnh thu h\u00fat kh\u00e1ch h\u00e0ng r\u00f5 r\u00e0ng<\/li>\n\n\n\n<li>T\u00ean s\u1ea3n ph\u1ea9m thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 r\u00f5 r\u00e0ng<\/li>\n\n\n\n<li>Tr\u1ea1ng th\u00e1i m\u00e0 ng\u01b0\u1eddi d\u00e2n th\u00f4ng th\u01b0\u1eddng c\u00f3 th\u1ec3 nh\u1eadn bi\u1ebft<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ve_doi_tuong_cua_quy_dinh_quang_cao_thiet_bi_y_te\"><\/span>V\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0110i\u1ec3m c\u1ea7n l\u01b0u \u00fd v\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 kh\u00f4ng c\u00f3 gi\u1edbi h\u1ea1n v\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng, m\u1ecdi ng\u01b0\u1eddi \u0111\u1ec1u l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh.<\/p>\n\n\n\n<p>Do \u0111\u00f3, ngay c\u1ea3 khi kh\u00f4ng ph\u1ea3i l\u00e0 doanh nghi\u1ec7p b\u00e1n thi\u1ebft b\u1ecb y t\u1ebf, n\u1ebfu ti\u1ebfn h\u00e0nh qu\u1ea3ng c\u00e1o v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf, b\u1ea1n s\u1ebd ph\u1ea3i tu\u00e2n theo quy \u0111\u1ecbnh c\u1ee7a Ph\u00e1p lu\u1eadt Yakuji.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bieu_hien_nao_la_doi_tuong_cua_quy_dinh\"><\/span>Bi\u1ec3u hi\u1ec7n n\u00e0o l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Nh\u01b0 \u0111\u00e3 n\u00eau tr\u01b0\u1edbc \u0111\u00e2y, \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a quy \u0111\u1ecbnh theo Ph\u00e1p lu\u1eadt Yakuji l\u00e0 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. (\u0110i\u1ec1u 66) v\u00e0 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (\u0110i\u1ec1u 68).<\/p>\n\n\n\n<p>V\u00ec v\u1eady, d\u01b0\u1edbi \u0111\u00e2y, ch\u00fang t\u00f4i s\u1ebd gi\u1ea3i th\u00edch chi ti\u1ebft v\u1ec1 t\u1eebng quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ve_viec_cam_quang_cao_phong_dai_vv_lien_quan_den_thiet_bi_y_te_Dieu_66\"><\/span>V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf (\u0110i\u1ec1u 66)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u0110i\u1ec1u 66 c\u1ee7a Ph\u00e1p lu\u1eadt Yakuji quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v.)<br>\u0110i\u1ec1u 66: Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3 ho\u1eb7c lan truy\u1ec1n th\u00f4ng tin gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u su\u1ea5t c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, d\u00f9 r\u00f5 r\u00e0ng hay ng\u1ee5 \u00fd.<br>2: Vi\u1ec7c qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3 ho\u1eb7c lan truy\u1ec1n th\u00f4ng tin c\u00f3 th\u1ec3 g\u00e2y hi\u1ec3u l\u1ea7m r\u1eb1ng m\u1ed9t b\u00e1c s\u0129 ho\u1eb7c ng\u01b0\u1eddi kh\u00e1c \u0111\u00e3 b\u1ea3o \u0111\u1ea3m c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u su\u1ea5t c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 vi ph\u1ea1m \u0111i\u1ec1u tr\u00ean.<br>3: Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p ng\u1ee5 \u00fd vi\u1ec7c ph\u00e1 thai ho\u1eb7c s\u1eed d\u1ee5ng t\u00e0i li\u1ec7u ho\u1eb7c h\u00ecnh v\u1ebd khi\u00eau d\u00e2m li\u00ean quan \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o.<\/p>\n<\/blockquote>\n\n\n\n<p>N\u1ed9i dung v\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c t\u1ed5ng h\u1ee3p nh\u01b0 sau:<\/p>\n\n\n\n<ul>\n<li>C\u1ea5m qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3, lan truy\u1ec1n th\u00f4ng tin gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3, hi\u1ec7u su\u1ea5t c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n\n\n\n<li>C\u1ea5m qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3, lan truy\u1ec1n th\u00f4ng tin c\u00f3 th\u1ec3 g\u00e2y hi\u1ec3u l\u1ea7m r\u1eb1ng m\u1ed9t b\u00e1c s\u0129, v.v. \u0111\u00e3 b\u1ea3o \u0111\u1ea3m c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u su\u1ea5t c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n\n\n\n<li>C\u1ea5m ng\u1ee5 \u00fd vi\u1ec7c ph\u00e1 thai ho\u1eb7c s\u1eed d\u1ee5ng t\u00e0i li\u1ec7u, h\u00ecnh v\u1ebd khi\u00eau d\u00e2m li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<\/ul>\n\n\n\n<p>V\u00ed d\u1ee5 \u0111i\u1ec3n h\u00ecnh v\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, v.v. li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 tr\u01b0\u1eddng h\u1ee3p qu\u1ea3ng c\u00e1o c\u00f3 hi\u1ec7u qu\u1ea3 l\u1edbn m\u1eb7c d\u00f9 thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng c\u00f3 hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u qu\u1ea3 r\u1ea5t nh\u1ecf. Ngo\u00e0i ra, c\u0169ng c\u00f3 th\u1ec3 xem x\u00e9t tr\u01b0\u1eddng h\u1ee3p qu\u1ea3ng c\u00e1o c\u00f3 c\u01a1 s\u1edf v\u1ec1 hi\u1ec7u qu\u1ea3 c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng c\u00e1ch ch\u1ec9 ra d\u1eef li\u1ec7u c\u1ee5 th\u1ec3, nh\u01b0ng d\u1eef li\u1ec7u c\u1ee5 th\u1ec3 \u0111\u00f3 l\u00e0 d\u1eef li\u1ec7u gi\u1ea3 m\u1ea1o \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ec9nh s\u1eeda.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ve_viec_cam_quang_cao_thiet_bi_y_te_truoc_khi_duoc_phe_duyet_Dieu_68\"><\/span>V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (\u0110i\u1ec1u 68)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u0110i\u1ec1u 68 c\u1ee7a Ph\u00e1p lu\u1eadt Yakuji quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(C\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t)<br>\u0110i\u1ec1u 68: Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p qu\u1ea3ng c\u00e1o v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u su\u1ea5t c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong \u0110i\u1ec1u 14 Kho\u1ea3n 1, \u0110i\u1ec1u 23-2-5 Kho\u1ea3n 1 ho\u1eb7c \u0110i\u1ec1u 23-2-23 Kho\u1ea3n 1 m\u00e0 ch\u01b0a nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 ph\u00ea duy\u1ec7t ho\u1eb7c ch\u1ee9ng nh\u1eadn theo \u0110i\u1ec1u 14 Kho\u1ea3n 1, \u0110i\u1ec1u 19-2 Kho\u1ea3n 1, \u0110i\u1ec1u 23-2-5 Kho\u1ea3n 1, \u0110i\u1ec1u 23-2-17 Kho\u1ea3n 1, \u0110i\u1ec1u 23-2-25 Kho\u1ea3n 1 ho\u1eb7c \u0110i\u1ec1u 23-2-37 Kho\u1ea3n 1 ho\u1eb7c \u0110i\u1ec1u 23-2-23 Kho\u1ea3n 1.<\/p>\n<\/blockquote>\n\n\n\n<p>V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, qu\u1ea3ng c\u00e1o v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c hi\u1ec7u su\u1ea5t c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (ho\u1eb7c ch\u1ee9ng nh\u1eadn) l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng c\u1ee7a l\u1ec7nh c\u1ea5m.<\/p>\n\n\n\n<p>V\u1ec1 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, ngay c\u1ea3 khi \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u1edf n\u01b0\u1edbc ngo\u00e0i, n\u1ebfu ch\u01b0a \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u1edf Nh\u1eadt B\u1ea3n, vi\u1ec7c qu\u1ea3ng c\u00e1o s\u1ebd vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, v\u00ec v\u1eady c\u1ea7n ph\u1ea3i c\u1ea9n th\u1eadn.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tong_ket\"><\/span>T\u1ed5ng k\u1ebft<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/Monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation3.jpg\" alt=\"\" class=\"wp-image-45030\" \/><\/figure><\/div>\n\n\n<p>Ch\u00fang t\u00f4i \u0111\u00e3 gi\u1edbi thi\u1ec7u v\u1ec1 quy \u0111\u1ecbnh ph\u00e1p l\u00fd li\u00ean quan \u0111\u1ebfn qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf d\u00e0nh cho nh\u1eefng doanh nghi\u1ec7p \u0111ang c\u00e2n nh\u1eafc vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf, n\u1ebfu b\u1ea1n \u0111\u0103ng qu\u1ea3ng c\u00e1o m\u00e0 kh\u00f4ng ki\u1ec3m tra k\u1ef9 n\u1ed9i dung, c\u00f3 th\u1ec3 s\u1ebd vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act).<\/p>\n\n\n\n<p>Do \u0111\u00f3, nh\u1eefng doanh nghi\u1ec7p \u0111ang c\u00e2n nh\u1eafc vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf c\u1ea7n ph\u1ea3i c\u1ea9n th\u1eadn.<\/p>\n\n\n\n<p>Vi\u1ec7c c\u00f3 vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf hay kh\u00f4ng s\u1ebd \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u1ef1a tr\u00ean hi\u1ec7u qu\u1ea3 th\u1ef1c t\u1ebf c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 m\u1ed1i li\u00ean h\u1ec7 v\u1edbi n\u1ed9i dung qu\u1ea3ng c\u00e1o m\u00e0 b\u1ea1n \u0111ang c\u00e2n nh\u1eafc \u0111\u0103ng.<\/p>\n\n\n\n<p>\u0110\u1ec3 x\u00e1c \u0111\u1ecbnh xem qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n hay kh\u00f4ng, b\u1ea1n c\u1ea7n ph\u1ea3i th\u1ef1c hi\u1ec7n m\u1ed9t ph\u00e1n \u0111o\u00e1n chuy\u00ean m\u00f4n.<\/p>\n\n\n\n<p>Do \u0111\u00f3, ch\u00fang t\u00f4i khuy\u1ebfn ngh\u1ecb nh\u1eefng doanh nghi\u1ec7p \u0111ang c\u00e2n nh\u1eafc vi\u1ec7c \u0111\u0103ng qu\u1ea3ng c\u00e1o thi\u1ebft b\u1ecb y t\u1ebf n\u00ean tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0 c\u00f3 ki\u1ebfn th\u1ee9c chuy\u00ean m\u00f4n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Huong_dan_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\"><\/span>H\u01b0\u1edbng d\u1eabn c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>V\u0103n ph\u00f2ng lu\u1eadt s\u01b0 Monolis, chuy\u00ean v\u1ec1 IT, \u0111\u1eb7c bi\u1ec7t l\u00e0 Internet v\u00e0 lu\u1eadt, l\u00e0 m\u1ed9t v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u00f3 chuy\u00ean m\u00f4n cao v\u1ec1 c\u1ea3 hai m\u1eb7t. G\u1ea7n \u0111\u00e2y, vi ph\u1ea1m &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n&#8217; trong l\u0129nh v\u1ef1c qu\u1ea3ng c\u00e1o tr\u00ean m\u1ea1ng \u0111\u00e3 tr\u1edf th\u00e0nh m\u1ed9t v\u1ea5n \u0111\u1ec1 l\u1edbn, v\u00e0 nhu c\u1ea7u ki\u1ec3m tra ph\u00e1p l\u00fd ng\u00e0y c\u00e0ng t\u0103ng. V\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i ph\u00e2n t\u00edch r\u1ee7i ro ph\u00e1p l\u00fd li\u00ean quan \u0111\u1ebfn doanh nghi\u1ec7p \u0111\u00e3 b\u1eaft \u0111\u1ea7u ho\u1eb7c \u0111ang chu\u1ea9n b\u1ecb b\u1eaft \u0111\u1ea7u, d\u1ef1a tr\u00ean c\u00e1c quy \u0111\u1ecbnh c\u1ee7a nhi\u1ec1u lu\u1eadt kh\u00e1c nhau, v\u00e0 c\u1ed1 g\u1eafng h\u1ee3p ph\u00e1p h\u00f3a doanh nghi\u1ec7p m\u00e0 kh\u00f4ng c\u1ea7n ph\u1ea3i d\u1eebng l\u1ea1i. Chi ti\u1ebft \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u00e0i vi\u1ebft d\u01b0\u1edbi \u0111\u00e2y.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u00f3 nhi\u1ec1u lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c nhau. Trong s\u1ed1 \u0111\u00f3, c\u00f3 nh\u1eefng thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 \u1ea3nh h\u01b0\u1edfng l\u1edbn \u0111\u1ebfn c\u01a1 th\u1ec3 v\u00e0 s\u1ee9c kh\u1ecfe c\u1ee7a ch\u00fang ta. N\u1ebfu qu\u1ea3ng c\u00e1o kh\u00f4ng ph\u00f9 h\u1ee3p v\u1ec1 c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf n\u00e0y \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i, c\u00f3  [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":60105,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[30,24],"acf":[],"_links":{"self":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/60009"}],"collection":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/comments?post=60009"}],"version-history":[{"count":1,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/60009\/revisions"}],"predecessor-version":[{"id":60106,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/60009\/revisions\/60106"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media\/60105"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media?parent=60009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/categories?post=60009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/tags?post=60009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}