{"id":6882,"date":"2025-01-20T13:54:32","date_gmt":"2025-01-20T06:54:32","guid":{"rendered":"https:\/\/jasaipakdanizinedar.com\/?p=6882"},"modified":"2025-10-13T15:55:26","modified_gmt":"2025-10-13T08:55:26","slug":"dokumen-penting-untuk-mengajukan-izin-edar-akl-checklist-lengkap","status":"publish","type":"post","link":"https:\/\/jasaipakdanizinedar.com\/en\/dokumen-penting-untuk-mengajukan-izin-edar-akl-checklist-lengkap\/","title":{"rendered":"# Essential Documents for AKL License Application: A Complete Checklist"},"content":{"rendered":"<blockquote class=\"instagram-media\" data-instgrm-captioned data-instgrm-permalink=\"https:\/\/www.instagram.com\/reel\/DMrfyVSy1RK\/?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\/DMrfyVSy1RK\/?utm_source=ig_embed&amp;utm_campaign=loading\" style=\" background:#FFFFFF; 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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\/DMrfyVSy1RK\/?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<h3 class=\"wp-block-heading\">Kesalahan Umum dalam Penyusunan Dokumen<\/h3>\n\n\n\n<p>Mengurus izin edar alat kesehatan (AKL) merupakan langkah penting bagi distributor yang ingin memasarkan produk impor secara legal di Indonesia. Proses ini memerlukan kelengkapan dokumen yang harus sesuai dengan persyaratan Kementerian Kesehatan. Artikel ini memberikan <strong>checklist lengkap dokumen penting<\/strong> yang harus disiapkan agar pengajuan izin edar Anda berjalan lancar.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"585\" src=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-1024x585.webp\" alt=\"\" class=\"wp-image-6884\" srcset=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-1024x585.webp 1024w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-300x171.webp 300w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-768x439.webp 768w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-1536x878.webp 1536w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/Dokumen-AKL-2-2048x1170.webp 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What is an AKL License?<\/strong><\/h4>\n\n\n\n<p>Kementerian Kesehatan menerbitkan izin edar AKL sebagai sertifikat resmi. Sertifikat ini menjamin bahwa alat kesehatan yang beredar telah memenuhi standar keamanan, mutu, dan manfaat. Izin ini wajib dimiliki oleh semua produk alat kesehatan impor sebelum dipasarkan.<\/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>Checklist Dokumen Penting untuk Izin Edar AKL<\/strong><\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>IDAK (Izin Distribusi Alat Kesehatan)<\/strong><\/li>\n\n\n\n<li><strong>Sertifikat<\/strong> <strong>CDAKB (Good Distribution Practice for Medical Devices)<\/strong><\/li>\n\n\n\n<li><strong>Akta Perusahaan dan SK (Surat Keputusan)<\/strong><\/li>\n\n\n\n<li><strong>NIB (Nomor Induk Berusaha) dengan KBLI Terkait<\/strong><\/li>\n\n\n\n<li><strong>PKKPR (Persetujuan Kesesuaian Kegiatan Pemanfaatan Ruang)<\/strong><\/li>\n\n\n\n<li><strong>Trademark Certificate<\/strong><\/li>\n\n\n\n<li><strong>Tenaga Ahli<\/strong><\/li>\n\n\n\n<li><strong>Laporan Uji Produk di Indonesia (Jika OEM)<\/strong><\/li>\n\n\n\n<li><strong>Terjemahan oleh Penerjemah Tersumpah<\/strong><br><\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img decoding=\"async\" width=\"1024\" height=\"584\" src=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-1024x584.webp\" alt=\"\" class=\"wp-image-6885\" style=\"width:898px;height:auto\" srcset=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-1024x584.webp 1024w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-300x171.webp 300w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-768x438.webp 768w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-1536x876.webp 1536w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/01\/TIPS-MJB-2048x1168.webp 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Penjelasan Tambahan untuk Kelancaran Proses<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pentingnya IDAK dan CDAKB:<\/strong><br>Dua dokumen ini adalah dasar legalitas bagi perusahaan yang bergerak di bidang alat kesehatan. Tanpa IDAK dan CDAKB, perusahaan tidak dapat mengajukan izin edar.<\/li>\n\n\n\n<li><strong>Relevansi KBLI pada Akta dan NIB:<\/strong><br>Untuk mematuhi regulasi, KBLI harus mencerminkan bidang usaha alat kesehatan. Selanjutnya, periksa kembali apakah kode KBLI Anda mencakup distribusi, produksi, atau aktivitas lain terkait alat kesehatan.<\/li>\n\n\n\n<li><strong>Uji Produk Lokal untuk OEM:<\/strong><br>Petugas melakukan uji ini untuk memastikan produk luar negeri memenuhi standar yang berlaku di Indonesia. Ini menjadi syarat penting bagi produk OEM sebelum mendapatkan izin edar.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-default\"\/>\n\n\n\n<p>Dengan mempersiapkan dokumen di atas, proses pengajuan izin edar AKL Anda dapat berjalan lebih lancar. Jika membutuhkan panduan lebih detail atau bantuan administrasi, <strong>PT Multi Jasa Berjaya<\/strong> siap mendampingi Anda dengan layanan profesional.<\/p>\n\n\n\n<p>Semoga informasi ini bermanfaat! \ud83d\ude0a<\/p>\n\n\n\n<p>\ud83d\udd17 <a href=\"https:\/\/api.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\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0);color:#4d5bff\" class=\"has-inline-color\">Klik disini<\/mark><\/strong><\/a> dan dapatkan 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) Kesalahan Umum dalam Penyusunan Dokumen Mengurus izin edar alat kesehatan (AKL) merupakan langkah penting bagi distributor yang ingin memasarkan produk impor secara legal di Indonesia. Proses ini memerlukan kelengkapan dokumen yang harus sesuai dengan persyaratan Kementerian Kesehatan. Artikel ini memberikan checklist lengkap [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6884,"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":[119,164,165,117,180,163,121,147,177,179,125,124,146,181,178,148],"class_list":["post-6882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bisnis-regulasi","tag-akd","tag-akd-penolakan","tag-akd-perbaikan","tag-akl","tag-akl-perbaikan","tag-alat-kesehatan","tag-alkes","tag-cepat","tag-distribusi-alkes","tag-izin-edar-perbaikan","tag-jasa","tag-konsultan","tag-murah","tag-penolakan","tag-produksi-alkes","tag-terpercaya"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dokumen Penting untuk Mengajukan Izin Edar AKL - 0812 1968 3506<\/title>\n<meta name=\"description\" content=\"Dokumen penting izin edar AKL wajib dipenuhi produsen dan distributor agar dapat memasarkan produk alat kesehatan secara legal di Indonesia.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jasaipakdanizinedar.com\/en\/dokumen-penting-untuk-mengajukan-izin-edar-akl-checklist-lengkap\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dokumen Penting untuk Mengajukan Izin Edar AKL - 0812 1968 3506\" \/>\n<meta property=\"og:description\" content=\"Dokumen penting izin edar AKL wajib dipenuhi produsen dan distributor agar dapat memasarkan produk alat kesehatan secara legal di Indonesia.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/jasaipakdanizinedar.com\/en\/dokumen-penting-untuk-mengajukan-izin-edar-akl-checklist-lengkap\/\" \/>\n<meta property=\"og:site_name\" content=\"PT. 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