{"id":2795,"date":"2025-10-01T08:35:09","date_gmt":"2025-10-01T01:35:09","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=2795"},"modified":"2025-11-26T09:55:58","modified_gmt":"2025-11-26T02:55:58","slug":"kewajiban-pelaporan-audit-internal-bagi-perusahaan-alkes-pemegang-sertifikat-cdakb","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/kewajiban-pelaporan-audit-internal-bagi-perusahaan-alkes-pemegang-sertifikat-cdakb\/","title":{"rendered":"Obligation to Submit Internal Audit Reports for Medical Device Companies Holding GDPMD Certificates"},"content":{"rendered":"<p>An update from the Ministry of Health of the Republic of Indonesia states that all medical device companies that hold a Good Distribution Practice for Medical Devices (GDMPD) certificate are required to submit their internal audit reports to the Ministry of Health once a year.<\/p>\n\n\n\n<p>This requirement refers to the new regulation, Government Regulation (PP) No. 28 of 2025 concerning Risk-Based Business Licensing Implementation, specifically Article 238, Paragraph 3, which outlines the supervision and inspection of business operator reports.<\/p>\n\n\n\n<p>This regulation will come<strong> <\/strong>into effect in September 2025. Internal audit reports can be submitted via email to <a href=\"mailto:audit.cdakb@gmail.com\">audit.cdakb@gmail.com<\/a><strong>. <\/strong>Companies are only required to submit proof or a summary (resume) of the internal audit implementation to fulfill this obligation.<\/p>\n\n\n\n<p>Companies that fail to submit their annual internal audit reports may face serious sanctions from the Ministry of Health, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Revocation of Distribution Permit Number (NIE)<\/li>\n\n\n\n<li>Withdrawal of the CDAKB Certificate<\/li>\n\n\n\n<li>Closure of access to PB UMKU licensing applications via OSS RBA<\/li>\n<\/ul>\n\n\n\n<p>With the introduction of this new regulation, it is expected that all medical device business operators will become more proactive and compliant in fulfilling their internal audit obligations, as part of a more transparent and accountable supervision system for medical device distribution.<\/p>\n\n\n\n<p>Source :<\/p>\n\n\n\n<p><a href=\"https:\/\/drive.google.com\/file\/d\/18IB_HbKe8kf7GA3UDdRjY9hfMnwLlrgs\/view?usp=sharing\" target=\"_blank\" rel=\"noopener\" title=\"\">Surat Pemberitahuan Penyampaian Laporan Hasil Audit Internal oleh Distributor Alkes<\/a><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\" id=\"https:\/\/derayglobalutama.com\/contact-us\/\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-medium-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/derayglobalutama.com\/en\/contact-us\/\" style=\"border-radius:89px;background-color:#a9653c\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Contact Us<\/strong><\/a><\/div>\n<\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Pembaruan informasi dari Kementerian Kesehatan Republik Indonesia menyebutkan bahwa seluruh perusahaan alat kesehatan (Alkes) yang telah memiliki Sertifikat Cara Distribusi Alat Kesehatan yang Baik (CDAKB) wajib melaporkan hasil audit internal perusahaan kepada Kemenkes satu kali dalam setahun. Ketentuan ini merujuk pada regulasi baru, yaitu Peraturan Pemerintah (PP) Nomor 28 Tahun 2025 tentang Penyelenggaraan Perizinan Berusaha [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":2796,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2795","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"rttpg_featured_image_url":{"full":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"landscape":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"portraits":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-150x150.png",150,150,true],"medium":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-300x164.png",300,164,true],"large":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"1536x1536":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"2048x2048":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2.png",771,421,false],"trp-custom-language-flag":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-18x10.png",18,10,true],"woocommerce_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-300x300.png",300,300,true],"woocommerce_single":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-600x328.png",600,328,true],"woocommerce_gallery_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2025\/10\/thumbnail-Page-2-100x100.png",100,100,true]},"rttpg_author":{"display_name":"admin web","author_link":"https:\/\/derayglobalutama.com\/en\/author\/admin-web\/"},"rttpg_comment":3,"rttpg_category":"<a href=\"https:\/\/derayglobalutama.com\/en\/category\/blog\/\" rel=\"category tag\">Blog<\/a>","rttpg_excerpt":"Pembaruan informasi dari Kementerian Kesehatan Republik Indonesia menyebutkan bahwa seluruh perusahaan alat kesehatan (Alkes) yang telah memiliki Sertifikat Cara Distribusi Alat Kesehatan yang Baik (CDAKB) wajib melaporkan hasil audit internal perusahaan kepada Kemenkes satu kali dalam setahun. Ketentuan ini merujuk pada regulasi baru, yaitu Peraturan Pemerintah (PP) Nomor 28 Tahun 2025 tentang Penyelenggaraan Perizinan Berusaha&hellip;","_links":{"self":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/2795","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/comments?post=2795"}],"version-history":[{"count":3,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/2795\/revisions"}],"predecessor-version":[{"id":2801,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/2795\/revisions\/2801"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media\/2796"}],"wp:attachment":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media?parent=2795"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/categories?post=2795"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/tags?post=2795"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}