{"id":6949,"date":"2025-01-31T16:56:05","date_gmt":"2025-01-31T09:56:05","guid":{"rendered":"https:\/\/jasaipakdanizinedar.com\/?p=6949"},"modified":"2025-10-31T15:27:34","modified_gmt":"2025-10-31T08:27:34","slug":"mewujudkan-kemandirian-industri-alat-kesehatan-panduan-mengurus-izin-akd","status":"publish","type":"post","link":"https:\/\/jasaipakdanizinedar.com\/en\/mewujudkan-kemandirian-industri-alat-kesehatan-panduan-mengurus-izin-akd\/","title":{"rendered":"# Achieving Self-Reliance in the Medical Device Industry: A Guide to Managing AKD Licensing"},"content":{"rendered":"<blockquote class=\"instagram-media\" data-instgrm-captioned data-instgrm-permalink=\"https:\/\/www.instagram.com\/reel\/DM_8DgES-4F\/?utm_source=ig_embed&amp;utm_campaign=loading\" data-instgrm-version=\"14\" style=\" background:#FFF; border:0; border-radius:3px; box-shadow:0 0 1px 0 rgba(0,0,0,0.5),0 1px 10px 0 rgba(0,0,0,0.15); margin: 1px; max-width:540px; min-width:326px; padding:0; width:99.375%; width:-webkit-calc(100% - 2px); width:calc(100% - 2px);\"><div style=\"padding:16px;\"> <a href=\"https:\/\/www.instagram.com\/reel\/DM_8DgES-4F\/?utm_source=ig_embed&amp;utm_campaign=loading\" style=\" background:#FFFFFF; line-height:0; padding:0 0; text-align:center; text-decoration:none; width:100%;\" target=\"_blank\"> <div style=\" display: flex; flex-direction: row; align-items: center;\"> <div style=\"background-color: #F4F4F4; border-radius: 50%; flex-grow: 0; height: 40px; margin-right: 14px; width: 40px;\"><\/div> <div style=\"display: flex; flex-direction: column; flex-grow: 1; justify-content: center;\"> <div style=\" background-color: #F4F4F4; border-radius: 4px; flex-grow: 0; height: 14px; margin-bottom: 6px; width: 100px;\"><\/div> <div style=\" background-color: #F4F4F4; border-radius: 4px; flex-grow: 0; height: 14px; width: 60px;\"><\/div><\/div><\/div><div style=\"padding: 19% 0;\"><\/div> <div style=\"display:block; height:50px; margin:0 auto 12px; width:50px;\"><svg width=\"50px\" height=\"50px\" viewbox=\"0 0 60 60\" version=\"1.1\" xmlns=\"https:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"https:\/\/www.w3.org\/1999\/xlink\"><g stroke=\"none\" stroke-width=\"1\" fill=\"none\" fill-rule=\"evenodd\"><g transform=\"translate(-511.000000, -20.000000)\" fill=\"#000000\"><g><path d=\"M556.869,30.41 C554.814,30.41 553.148,32.076 553.148,34.131 C553.148,36.186 554.814,37.852 556.869,37.852 C558.924,37.852 560.59,36.186 560.59,34.131 C560.59,32.076 558.924,30.41 556.869,30.41 M541,60.657 C535.114,60.657 530.342,55.887 530.342,50 C530.342,44.114 535.114,39.342 541,39.342 C546.887,39.342 551.658,44.114 551.658,50 C551.658,55.887 546.887,60.657 541,60.657 M541,33.886 C532.1,33.886 524.886,41.1 524.886,50 C524.886,58.899 532.1,66.113 541,66.113 C549.9,66.113 557.115,58.899 557.115,50 C557.115,41.1 549.9,33.886 541,33.886 M565.378,62.101 C565.244,65.022 564.756,66.606 564.346,67.663 C563.803,69.06 563.154,70.057 562.106,71.106 C561.058,72.155 560.06,72.803 558.662,73.347 C557.607,73.757 556.021,74.244 553.102,74.378 C549.944,74.521 548.997,74.552 541,74.552 C533.003,74.552 532.056,74.521 528.898,74.378 C525.979,74.244 524.393,73.757 523.338,73.347 C521.94,72.803 520.942,72.155 519.894,71.106 C518.846,70.057 518.197,69.06 517.654,67.663 C517.244,66.606 516.755,65.022 516.623,62.101 C516.479,58.943 516.448,57.996 516.448,50 C516.448,42.003 516.479,41.056 516.623,37.899 C516.755,34.978 517.244,33.391 517.654,32.338 C518.197,30.938 518.846,29.942 519.894,28.894 C520.942,27.846 521.94,27.196 523.338,26.654 C524.393,26.244 525.979,25.756 528.898,25.623 C532.057,25.479 533.004,25.448 541,25.448 C548.997,25.448 549.943,25.479 553.102,25.623 C556.021,25.756 557.607,26.244 558.662,26.654 C560.06,27.196 561.058,27.846 562.106,28.894 C563.154,29.942 563.803,30.938 564.346,32.338 C564.756,33.391 565.244,34.978 565.378,37.899 C565.522,41.056 565.552,42.003 565.552,50 C565.552,57.996 565.522,58.943 565.378,62.101 M570.82,37.631 C570.674,34.438 570.167,32.258 569.425,30.349 C568.659,28.377 567.633,26.702 565.965,25.035 C564.297,23.368 562.623,22.342 560.652,21.575 C558.743,20.834 556.562,20.326 553.369,20.18 C550.169,20.033 549.148,20 541,20 C532.853,20 531.831,20.033 528.631,20.18 C525.438,20.326 523.257,20.834 521.349,21.575 C519.376,22.342 517.703,23.368 516.035,25.035 C514.368,26.702 513.342,28.377 512.574,30.349 C511.834,32.258 511.326,34.438 511.181,37.631 C511.035,40.831 511,41.851 511,50 C511,58.147 511.035,59.17 511.181,62.369 C511.326,65.562 511.834,67.743 512.574,69.651 C513.342,71.625 514.368,73.296 516.035,74.965 C517.703,76.634 519.376,77.658 521.349,78.425 C523.257,79.167 525.438,79.673 528.631,79.82 C531.831,79.965 532.853,80.001 541,80.001 C549.148,80.001 550.169,79.965 553.369,79.82 C556.562,79.673 558.743,79.167 560.652,78.425 C562.623,77.658 564.297,76.634 565.965,74.965 C567.633,73.296 568.659,71.625 569.425,69.651 C570.167,67.743 570.674,65.562 570.82,62.369 C570.966,59.17 571,58.147 571,50 C571,41.851 570.966,40.831 570.82,37.631\"><\/path><\/g><\/g><\/g><\/svg><\/div><div style=\"padding-top: 8px;\"> <div style=\" color:#3897f0; font-family:Arial,sans-serif; font-size:14px; font-style:normal; font-weight:550; line-height:18px;\">Lihat postingan ini di Instagram<\/div><\/div><div style=\"padding: 12.5% 0;\"><\/div> <div style=\"display: flex; flex-direction: row; margin-bottom: 14px; align-items: center;\"><div> <div style=\"background-color: #F4F4F4; border-radius: 50%; height: 12.5px; width: 12.5px; transform: translateX(0px) translateY(7px);\"><\/div> <div style=\"background-color: #F4F4F4; height: 12.5px; transform: rotate(-45deg) translateX(3px) translateY(1px); width: 12.5px; flex-grow: 0; margin-right: 14px; margin-left: 2px;\"><\/div> <div style=\"background-color: #F4F4F4; border-radius: 50%; height: 12.5px; width: 12.5px; transform: translateX(9px) translateY(-18px);\"><\/div><\/div><div style=\"margin-left: 8px;\"> <div style=\" background-color: #F4F4F4; border-radius: 50%; flex-grow: 0; height: 20px; width: 20px;\"><\/div> <div style=\" width: 0; height: 0; border-top: 2px solid transparent; border-left: 6px solid #f4f4f4; border-bottom: 2px solid transparent; transform: translateX(16px) translateY(-4px) rotate(30deg)\"><\/div><\/div><div style=\"margin-left: auto;\"> <div style=\" width: 0px; border-top: 8px solid #F4F4F4; border-right: 8px solid transparent; transform: translateY(16px);\"><\/div> <div style=\" background-color: #F4F4F4; flex-grow: 0; height: 12px; width: 16px; transform: translateY(-4px);\"><\/div> <div style=\" width: 0; height: 0; border-top: 8px solid #F4F4F4; border-left: 8px solid transparent; transform: translateY(-4px) translateX(8px);\"><\/div><\/div><\/div> <div style=\"display: flex; flex-direction: column; flex-grow: 1; justify-content: center; margin-bottom: 24px;\"> <div style=\" background-color: #F4F4F4; border-radius: 4px; flex-grow: 0; height: 14px; margin-bottom: 6px; width: 224px;\"><\/div> <div style=\" background-color: #F4F4F4; border-radius: 4px; flex-grow: 0; height: 14px; width: 144px;\"><\/div><\/div><\/a><p style=\" color:#c9c8cd; font-family:Arial,sans-serif; font-size:14px; line-height:17px; margin-bottom:0; margin-top:8px; overflow:hidden; padding:8px 0 7px; text-align:center; text-overflow:ellipsis; white-space:nowrap;\"><a href=\"https:\/\/www.instagram.com\/reel\/DM_8DgES-4F\/?utm_source=ig_embed&amp;utm_campaign=loading\" style=\" color:#c9c8cd; font-family:Arial,sans-serif; font-size:14px; font-style:normal; font-weight:normal; line-height:17px; text-decoration:none;\" target=\"_blank\">Sebuah kiriman dibagikan oleh Multi Jasa Berjaya (@multijasaberjaya)<\/a><\/p><\/div><\/blockquote>\n<script async src=\"\/\/www.instagram.com\/embed.js\"><\/script>\n\n\n\n<p>Industri alat kesehatan dalam negeri terus berkembang seiring dengan dorongan pemerintah untuk meningkatkan kemandirian produksi lokal. Salah satu langkah penting dalam mendukung pertumbuhan ini adalah mendapatkan <strong>Izin Edar AKD (Alat Kesehatan Dalam Negeri)<\/strong>. Pihak perusahaan tidak dapat memasarkan produk secara legal di Indonesia tanpa izin ini.<\/p>\n\n\n\n<p>Produsen lokal sering kali menghadapi tantangan dalam mengurus izin AKD karena harus memenuhi banyak persyaratan dan prosedur. Oleh karena itu, <strong>kami hadir sebagai solusi profesional untuk membantu Anda mendapatkan izin AKD dengan cepat, mudah, dan sesuai regulasi<\/strong>.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"581\" src=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-1024x581.webp\" alt=\"\" class=\"wp-image-6950\" srcset=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-1024x581.webp 1024w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-300x170.webp 300w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-768x436.webp 768w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-1536x871.webp 1536w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/pengajuan-AKD-2048x1161.webp 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Mengapa Izin AKD Itu Penting?<\/strong><\/h4>\n\n\n\n<p>Produsen alat kesehatan dalam negeri harus memperoleh izin AKD sebagai syarat utama agar produknya dapat beredar secara legal dan mendapat kepercayaan dari pasar. Beberapa alasan mengapa izin AKD sangat penting, antara lain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li> <strong>Memastikan Kepatuhan Regulasi<\/strong> \u2013 Produk yang memiliki izin edar telah melewati evaluasi dan dinyatakan memenuhi standar keamanan serta mutu oleh Kementerian Kesehatan.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li> <strong>Meningkatkan Kepercayaan Konsumen<\/strong> \u2013 Dengan izin resmi, produk alat kesehatan akan lebih dipercaya oleh rumah sakit, klinik, apotek, dan distributor.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li> <strong>Mendukung Pertumbuhan Bisnis<\/strong> \u2013 Izin edar membuka peluang lebih luas untuk menjual produk secara nasional, baik melalui tender pemerintah maupun distribusi swasta.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li> <strong>Memperkuat Daya Saing Produk Lokal<\/strong> \u2013 Dengan perizinan yang lengkap, produk alat kesehatan dalam negeri bisa bersaing dengan produk impor.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-wide\"\/>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Syarat Mengurus Izin AKD<\/strong><\/h4>\n\n\n\n<p>Sebelum mengajukan izin AKD, pastikan Anda telah menyiapkan dokumen berikut:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>IDAK<\/strong> &amp; <strong>Good Distribution Practice for Medical Devices (CDAKB) Certificate<\/strong> \u2013 Jika pengajuan dilakukan oleh perusahaan distributor, bukan produsen.<\/li>\n\n\n\n<li><strong>Akta PT &amp; SK<\/strong> \u2013 Harus mencantumkan KBLI yang relevan dengan alat kesehatan yang diproduksi.<\/li>\n\n\n\n<li><strong>NIB (Nomor Induk Berusaha) dengan KBLI yang Sesuai<\/strong> \u2013 Wajib terdaftar sesuai dengan jenis alat kesehatan yang diajukan.<\/li>\n\n\n\n<li><strong>PKKPR (Persetujuan Kesesuaian Kegiatan Pemanfaatan Ruang) Non-UMK<\/strong> \u2013 Diperlukan untuk perusahaan yang bukan termasuk usaha mikro dan kecil.<\/li>\n\n\n\n<li><strong>Trademark Certificate<\/strong> \u2013 Untuk memastikan bahwa produk yang didaftarkan memiliki perlindungan merek.<\/li>\n\n\n\n<li><strong>Tenaga Ahli<\/strong> \u2013 Harus memiliki tenaga ahli yang memenuhi syarat sesuai regulasi.<\/li>\n\n\n\n<li><strong>Uji Produk di Indonesia<\/strong> \u2013 Hanya diperlukan jika alat kesehatan diproduksi oleh OEM.<\/li>\n\n\n\n<li><strong>Terjemahan oleh Penerjemah Tersumpah<\/strong> \u2013 Jika ada dokumen yang memerlukan penerjemahan resmi.<\/li>\n<\/ol>\n\n\n\n<p>Kami memahami bahwa mengurus semua persyaratan ini bisa menjadi proses yang rumit dan memakan waktu. Oleh karena itu, <strong>kami siap membantu Anda dalam setiap tahap pengurusan izin AKD agar lebih mudah dan efisien<\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-wide\"\/>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Why Use Our Services?<\/strong><\/h4>\n\n\n\n<p> <strong>a.<\/strong> <strong>Proses Cepat dan Tepat<\/strong> \u2013 Kami berpengalaman dalam menangani izin alat kesehatan, sehingga proses berjalan  lancar tanpa hambatan.<\/p>\n\n\n\n<p> <strong>b.<\/strong> <strong>Dukungan dari Ahli Berpengalaman<\/strong> \u2013 Tim kami terdiri dari profesional yang memahami regulasi dan prosedur perizinan alat kesehatan.<\/p>\n\n\n\n<p> <strong>c. Kepatuhan Penuh terhadap Regulasi<\/strong> \u2013 Kami memastikan bahwa setiap dokumen yang diajukan sudah sesuai   dengan peraturan yang berlaku.<\/p>\n\n\n\n<p> <strong>d. Hemat Waktu &amp; Biaya<\/strong> \u2013 Anda tidak perlu repot mengurus sendiri perizinan yang rumit. Kami akan membantu dari awal hingga izin diterbitkan.<\/p>\n\n\n\n<p> <strong>e. Konsultasi Gratis<\/strong> \u2013 Kami siap memberikan konsultasi awal tanpa biaya untuk membantu Anda memahami kebutuhan dan proses perizinan.<\/p>\n\n\n\n<h4 class=\"wp-block-heading has-text-align-center\"><strong>Ingin Mengurus Izin AKD dengan Mudah? Hubungi Kami Sekarang!<\/strong><\/h4>\n\n\n\n<p>Jangan biarkan proses perizinan menghambat pertumbuhan bisnis Anda! Percayakan pengurusan izin AKD kepada kami dan fokuslah pada pengembangan serta pemasaran produk Anda.<\/p>\n\n\n\n<p><em>Untuk panduan lebih lengkap tentang pengurusan AKD (Alat Kesehatan Dalam Negeri), kunjungi halaman utama layanan kami di<\/em><strong><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/layanan-kami\/perizinan-kemenkes\/perizinan-ipak-idak\/\"> <\/a><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/layanan-kami\/perizinan-kemenkes\/izin-edar-alkes-dalam-negeri-akd\/\">Jasa Pengurusan Izin Edar AKD (Alat Kesehatan Dalam Negeri)<\/a><\/strong><\/p>\n\n\n\n<p>\ud83d\udd17 <em>Related Articles:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2025\/02\/12\/mengenal-perbedaan-alat-kesehatan-dan-pkrt-dalam-industri-kesehatan\/\">Understanding the Difference Between Medical Devices and PKRT in the Healthcare Industry<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2025\/01\/29\/perkembangan-industri-alat-kesehatan-dalam-negeri-tantangan-dan-peluang\/\">The Development of the Domestic Medical Device Industry: Challenges and Opportunities<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2025\/10\/31\/legalitas-bisnis-alat-kesehatan\/\">Legalitas Dulu, Baru Melaju: Kunci Sukses Bisnis Alkes di Indonesia<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2025\/10\/22\/panduan-persiapan-izin-idak-kemenkes\/\">Preparation Steps Before Applying for an IDAK License: A Practical Guide for Medical Device Distributors<\/a><\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udcde <a href=\"https:\/\/web.whatsapp.com\/send\/?phone=6281219683506&amp;text=Halo%2C+Multi+Jasa+Berjaya%2C+%0D%0A%0D%0ASaya+dengan+%3A+..%0D%0ADari+perusahaan+%3A+..+%0D%0Asaya+ingin+konsultasi+mengenai+perizinan+%E2%80%A6+%0D%0A%0D%0AMohon+info+mengenai%2C+%0D%0AHarga%0D%0APersyaratan%0D%0AEstimasi+waktu+%0D%0A%0D%0ADan+bagaimana+mekanisme+atau+alur+jika+ingin+dibantu+kepengurusannya+oleh+MJB%3F+%0D%0A%0D%0ATerimakasih&amp;type=phone_number&amp;app_absent=0&amp;utm_campaign=wa_api_send_v2\"><strong>Klik disini<\/strong><\/a> untuk konsultasi, Gratis!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Lihat postingan ini di Instagram Sebuah kiriman dibagikan oleh Multi Jasa Berjaya (@multijasaberjaya) Industri alat kesehatan dalam negeri terus berkembang seiring dengan dorongan pemerintah untuk meningkatkan kemandirian produksi lokal. Salah satu langkah penting dalam mendukung pertumbuhan ini adalah mendapatkan Izin Edar AKD (Alat Kesehatan Dalam Negeri). Pihak perusahaan tidak dapat memasarkan produk secara legal di [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6950,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[62],"tags":[119,164,165,173,167,121,166,175,147,123,174,124,172,148],"class_list":["post-6949","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bisnis-regulasi","tag-akd","tag-akd-penolakan","tag-akd-perbaikan","tag-akd-terbit","tag-alat-kesehatan-dari-dalam-negeri","tag-alkes","tag-alkes-lokal","tag-aman","tag-cepat","tag-izin-edar","tag-jasa-izin-edar","tag-konsultan","tag-panduan-proses-akd","tag-terpercaya"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Panduan Mengurus Izin AKD - 081219683506<\/title>\n<meta name=\"description\" content=\"Industri alat kesehatan lokal terus berkembang. 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