{"id":8810,"date":"2025-10-22T10:07:00","date_gmt":"2025-10-22T03:07:00","guid":{"rendered":"https:\/\/jasaipakdanizinedar.com\/?p=8810"},"modified":"2025-10-22T15:13:56","modified_gmt":"2025-10-22T08:13:56","slug":"panduan-persiapan-izin-idak-kemenkes","status":"publish","type":"post","link":"https:\/\/jasaipakdanizinedar.com\/en\/panduan-persiapan-izin-idak-kemenkes\/","title":{"rendered":"# Langkah Persiapan Sebelum Mengajukan Izin IDAK: Panduan Penting untuk Distributor Alat Kesehatan"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Sebelum memulai bisnis distribusi alat kesehatan, memahami <strong>proses dan persiapan pengajuan Izin IDAK (Izin Distribusi Alat Kesehatan)<\/strong> adalah langkah penting yang tidak boleh diabaikan. Izin ini merupakan dasar legalitas agar perusahaan dapat menyalurkan alat kesehatan secara sah di Indonesia, sesuai dengan <strong>Permenkes No. 14 Tahun 2021<\/strong> tentang <em>Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Kesehatan.<\/em><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK-1024x683.webp\" alt=\"\" class=\"wp-image-8815\" srcset=\"https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK-1024x683.webp 1024w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK-300x200.webp 300w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK-768x512.webp 768w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK-18x12.webp 18w, https:\/\/jasaipakdanizinedar.com\/wp-content\/uploads\/2025\/10\/dokumen-IDAK.webp 1536w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Dalam artikel ini, PT <strong>Multi Jasa Berjaya (MJB)<\/strong> akan membahas secara detail apa saja yang perlu Anda siapkan agar proses pengajuan IDAK berjalan lancar dan efisien.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>1. Memahami Fungsi dan Tujuan IDAK<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK atau <em>Izin Distribusi Alat Kesehatan<\/em> adalah izin resmi yang diterbitkan oleh <strong>Kementerian Kesehatan (Kemenkes)<\/strong> kepada perusahaan yang akan melakukan kegiatan distribusi, penyimpanan, dan penyaluran alat kesehatan dalam skala besar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dengan memiliki IDAK, perusahaan Anda:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Diakui secara <strong>resmi dan legal<\/strong> oleh pemerintah.<\/li>\n\n\n\n<li>Dapat mengikuti <strong>pengadaan pemerintah melalui e-Katalog LKPP<\/strong>.<\/li>\n\n\n\n<li>Memperoleh <strong>kepercayaan lebih<\/strong> dari mitra rumah sakit, klinik, maupun distributor lainnya.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tanpa izin ini, kegiatan distribusi alat kesehatan dianggap tidak sah dan berpotensi terkena sanksi administratif maupun hukum.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>2. Menyiapkan Legalitas Perusahaan yang Valid<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sebelum mengajukan IDAK, pastikan seluruh dokumen legalitas perusahaan Anda sudah lengkap dan sesuai regulasi terbaru. Beberapa hal penting yang perlu Anda periksa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Business Identification Number (NIB)<\/strong> dengan <strong>KBLI 46691<\/strong> sebagai kegiatan utama.<\/li>\n\n\n\n<li><strong>Akta Pendirian dan Perubahan Terbaru<\/strong> yang sudah menyesuaikan KBLI 2020.<\/li>\n\n\n\n<li><strong>NPWP dan Domisili Kantor<\/strong> yang jelas, bukan virtual office.<\/li>\n\n\n\n<li><strong>Nomor telepon tetap (fixed line)<\/strong> untuk keperluan verifikasi.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Dokumen ini menjadi dasar dalam pemeriksaan administratif di sistem Kemenkes. Jika salah satu tidak valid, pengajuan IDAK bisa tertunda.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>3. Menyiapkan Sumber Daya Manusia (PJT\/Tenaga Ahli)<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regulasi Kemenkes mensyaratkan perusahaan distribusi alat kesehatan memiliki <strong>Penanggung Jawab Teknis (PJT)\/tenaga ahli<\/strong> yang kompeten sesuai klasifikasi produk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Beberapa ketentuan penting:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Jumlah dan latar belakang pendidikan tenaga ahli menyesuaikan jenis alat kesehatan yang didistribusikan.<\/li>\n\n\n\n<li>Untuk <strong>alat elektromedik radiasi<\/strong>, wajib memiliki <strong>PPR (Petugas Proteksi Radiasi)<\/strong>.<\/li>\n\n\n\n<li>PJT harus bersedia mengikuti pelatihan untuk mendapatkan <strong>Sertifikat Kompetensi<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Pastikan seluruh personel teknis memiliki dokumen pendukung seperti ijazah, sertifikat, dan SK penunjukan.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>4. Memastikan Sarana dan Prasarana Memenuhi Standar<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kantor dan gudang distribusi merupakan bagian penting dari proses verifikasi IDAK. Lokasi harus <strong>nyata dan sesuai peruntukan<\/strong>, bukan sekadar alamat surat-menyurat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Beberapa poin yang perlu diperhatikan:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Layout atau denah ruangan harus sesuai fungsi (penyimpanan, administrasi, dan pengemasan).<\/li>\n\n\n\n<li>Lingkungan dan kondisi bangunan memenuhi standar keamanan dan kebersihan.<\/li>\n\n\n\n<li>Satu alamat hanya boleh digunakan untuk <strong>satu perusahaan pemegang IDAK<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tim MJB biasanya memberikan pendampingan langsung, termasuk pengarahan penataan ruangan dan dokumentasi foto lokasi untuk kebutuhan verifikasi Kemenkes.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>5. Melengkapi Dokumen Teknis dan Administratif<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Selain legalitas dasar, perusahaan juga wajib menyiapkan dokumen pendukung seperti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Struktur organisasi, daftar alat kesehatan yang akan didistribusikan.<\/li>\n\n\n\n<li>Denah bangunan dan foto sarana distribusi.<\/li>\n\n\n\n<li>Surat keterangan PJT dan daftar peralatan kerja.<\/li>\n\n\n\n<li>Akta Perjanjian PJT dan Perusahaan.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">MJB membantu memastikan seluruh dokumen ini lengkap dan sesuai format resmi sebelum diajukan ke sistem OSS-RBA dan Kemenkes.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>6. Pengajuan Melalui Sistem Kemenkes dan Monitoring Proses<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Setelah seluruh berkas diverifikasi, pengajuan dilakukan melalui sistem resmi Kemenkes yang terintegrasi dengan <strong>OSS-RBA<\/strong>.<br>Tahapan ini meliputi:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Upload dokumen perusahaan dan teknis.<\/li>\n\n\n\n<li>Pemeriksaan oleh petugas Kemenkes.<\/li>\n\n\n\n<li>Proses verifikasi dan validasi lapangan.<\/li>\n\n\n\n<li>Penerbitan <strong>Nomor IDAK resmi<\/strong>.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Durasi pengurusan umumnya 2\u20134 minggu tergantung kelengkapan berkas dan respon sistem.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>7. Tips Agar Proses IDAK Lancar dan Cepat<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pastikan <strong>KBLI, NIB, dan akta<\/strong> sudah disesuaikan dengan regulasi terbaru.<\/li>\n\n\n\n<li>Gunakan <strong>alamat dan gudang yang valid<\/strong>, bukan virtual office.<\/li>\n\n\n\n<li>Siapkan <strong>dokumen tenaga ahli<\/strong> sejak awal untuk mempercepat validasi.<\/li>\n\n\n\n<li>Gunakan pendampingan profesional agar terhindar dari kesalahan administrasi.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\ud83d\udcbc Percayakan Proses IDAK Anda pada Tim Profesional<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Mengurus izin IDAK membutuhkan ketelitian, pemahaman regulasi, dan ketepatan dokumen.<br>PT <strong>Multi Jasa Berjaya (MJB)<\/strong> hadir untuk membantu Anda dari tahap konsultasi, pemeriksaan dokumen, hingga izin resmi diterbitkan oleh Kemenkes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dengan pengalaman bertahun-tahun di bidang legalitas <strong>alat kesehatan dan PKRT<\/strong>, kami memastikan proses pengurusan izin berjalan <strong>cepat, aman, dan sesuai regulasi.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Untuk panduan lebih lengkap tentang pengurusan izin distribusi alat kesehatan (IDAK), kunjungi halaman utama layanan kami di<\/em><strong><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/layanan-kami\/perizinan-kemenkes\/perizinan-ipak-idak\/\"> Jasa Pengurusan IPAK\/IDAK PT Multi Jasa Berjaya<\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd17 <em>Related Articles:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2024\/09\/26\/cara-efektif-mendapatkan-izin-distribusi-alat-kesehatan\/\" target=\"_blank\" rel=\"noreferrer noopener\">Planning to Distribute Medical Devices? Effective Ways to Obtain a Medical Device Distribution License<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2024\/11\/19\/wajib-tahu-akta-notaris-kerjasama-pjt-syarat-baru-distributor-alat-kesehatan-2025\/\" target=\"_blank\" rel=\"noreferrer noopener\">Must Know! Notarial Deed of Cooperation with the Responsible Technical Officer (PJT): A New Requirement for Medical Device Distribution<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/jasaipakdanizinedar.com\/en\/2024\/10\/28\/sertifikasi-cdakb-kenali-persiapan-yang-harus-anda-lakukan\/\" target=\"_blank\" rel=\"noreferrer noopener\">CDAKB Certification: Understand the Preparations You Need to Make<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><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>Klik disini<\/strong><\/a> dan dapatkan Konsultasi Gratis!<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Sebelum memulai bisnis distribusi alat kesehatan, memahami proses dan persiapan pengajuan Izin IDAK (Izin Distribusi Alat Kesehatan) adalah langkah penting yang tidak boleh diabaikan. Izin ini merupakan dasar legalitas agar perusahaan dapat menyalurkan alat kesehatan secara sah di Indonesia, sesuai dengan Permenkes No. 14 Tahun 2021 tentang Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8815,"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":[163,177,160,202,227,226,232],"class_list":["post-8810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bisnis-regulasi","tag-alat-kesehatan","tag-distribusi-alkes","tag-idak","tag-ipak","tag-kemenkes","tag-legalitas-usaha","tag-mjb"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Langkah Persiapan Sebelum Mengajukan Izin IDAK: Panduan Penting untuk Distributor Alat Kesehatan<\/title>\n<meta name=\"description\" content=\"Pelajari langkah-langkah penting sebelum mengajukan Izin IDAK agar proses distribusi alat kesehatan Anda lancar. 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