{"id":3217,"date":"2026-11-12T08:00:00","date_gmt":"2026-11-12T01:00:00","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=3217"},"modified":"2026-11-11T21:16:45","modified_gmt":"2026-11-11T14:16:45","slug":"kemenkes-ubah-klasifikasi-alat-kesehatan-ivd-ini-rincian-dan-dampaknya-bagi-pemilik-nie","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/kemenkes-ubah-klasifikasi-alat-kesehatan-ivd-ini-rincian-dan-dampaknya-bagi-pemilik-nie\/","title":{"rendered":"Kemenkes Revises IVD Medical Device Classification: What It Means for Registration Holders"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Indonesia\u2019s Directorate General of Pharmaceutical and Medical Devices (Kemenkes) issued Circular Letter No. FR.03.01\/E.V\/2204\/2026 on October 16, 2026. It changes the category, subcategory, product type, and risk class of several In Vitro Diagnostic (IVD) medical devices.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Does the Circular Say?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The circular was signed by Hendro Santoso, Director of Medical Device Production and Distribution. It is addressed to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GAKESLAB;<\/li>\n\n\n\n<li>ASPAKI;<\/li>\n\n\n\n<li>HIPELKI;<\/li>\n\n\n\n<li>Heads of companies holding marketing authorization (NIE) for IVD medical devices<br><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The goal is to align product nomenclature with the international classification used as a reference. The change also clarifies product identity and grouping by assigning more specific product types than before. Details are in an attachment listing 16 rows of changes.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Impact on NIE Holders<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Existing NIEs remain valid.<\/strong> An NIE issued before the change, still using the previous product-type nomenclature, stays valid until its expiry date.<\/li>\n\n\n\n<li><strong>Nomenclature updates are optional.<\/strong> NIE holders may apply for the update through an amendment request, or through a renewal with NIE amendment, in accordance with applicable regulations.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Summary of Changes in the Attachment<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. New Product Types: Hepatitis B, Hepatitis C, and HIV (Nos. 1-9)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">These nine products were previously registered under autoantibody types (<em>antinuclear antibody<\/em>, <em>antimitochondrial antibody<\/em>, <em>multiple autoantibodies<\/em>). Each now has a specific product type under Immunology and Microbiology Equipment, subcategory Serology Reagents. <strong>Risk classes are unchanged.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table aligncenter\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>New product type<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Risk class<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Hepatitis C virus serological tests<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">NAT-based HCV RNA tests (monitoring, incl. viral load) <em>viral load<\/em>)<\/td><td class=\"has-text-align-center\" data-align=\"center\">C<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">NAT-based HCV RNA tests (diagnosis and\/or monitoring)<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Hepatitis B virus serological tests<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">NAT-based HBV tests (monitoring, incl. viral load) <em>viral load<\/em>)<\/td><td class=\"has-text-align-center\" data-align=\"center\">C<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">NAT-based HBV tests (diagnosis and\/or monitoring)<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">HIV viral load monitoring test<\/td><td class=\"has-text-align-center\" data-align=\"center\">C<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">HIV serological diagnostic and\/or supplemental test<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">HIV nucleic acid (NAT) diagnostic and\/or supplemental test<\/td><td class=\"has-text-align-center\" data-align=\"center\">D<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">2. Risk Class Upgrades (Nos. 10-14)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Lima baris mengalami kenaikan kelas risiko:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>No. 10, multi-target respiratory panel tests (including SARS-CoV-2):<\/strong> B to C. The product type also changes.<\/li>\n\n\n\n<li><strong>Nos. 11-12, immunohistochemistry (IHC) reagents and kits, qualitative (A) and quantitative (B):<\/strong> merged into one type at class C, under Hematology and Pathology.<\/li>\n\n\n\n<li><strong>No. 13, NAT detection <em>of Mycobacterium tuberculosis complex<\/em> (kit and liquid):<\/strong> B to C.<\/li>\n\n\n\n<li><strong>No. 14, NAT detection of MTBC plus antibiotic-resistance mutations (kit and liquid):<\/strong> B to C.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. Calibrators Move Category (Nos. 15-16)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Strip and liquid calibrators (class B) were previously under Clinical Chemistry and Clinical Toxicology. They are now merged into Calibrator for Immunological under Immunology and Microbiology Equipment, subcategory Immunological Test Systems. The risk class remains B. <em>Calibrator for Immunological<\/em> di Peralatan Imunologi dan Mikrobiologi, subkategori Sistem Tes Imunologikal. Kelas risiko tetap B.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Should Companies Do?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The circular does not require immediate changes. The steps below are general suggestions, not part of the circular:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Match your NIE product list against the 16 attachment rows.<\/li>\n\n\n\n<li>Pay attention to products whose risk class increased (Nos. 10-14), as this may affect registration requirements.<\/li>\n\n\n\n<li>Plan nomenclature updates for your next NIE amendment or renewal.<\/li>\n\n\n\n<li>Verify details against the official document at farmalkes.kemkes.go.id or with a regulatory consultant.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Existing NIEs stay valid, but the new nomenclature and risk classes should be understood now. This matters most for NAT, IHC, and TB tests, whose risk class rises to C.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source : <a href=\"https:\/\/derayglobalutama.com\/wp-content\/uploads\/2026\/11\/1001054.pdf\" target=\"_blank\" rel=\"noopener\">Surat Edaran Nomor FR.03.01\/E.V\/2204\/2026 Tentang Informasi Perubahan Kategori, Subkategori, Jenis, dan Kelas Risiko Alat Kesehatan Diagnostik In Vitri (IVD)<\/a><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de 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>","protected":false},"excerpt":{"rendered":"<p>Direktorat Jenderal Farmasi dan Alat Kesehatan Kemenkes menerbitkan Surat Edaran Nomor FR.03.01\/E.V\/2204\/2026 pada 16 Oktober 2026. Isinya perubahan kategori, subkategori, jenis produk, dan kelas risiko alat kesehatan Diagnostik In Vitro (IVD). Apa Isi Surat Edaran Ini? Surat edaran ditandatangani Direktur Produksi dan Distribusi Alat Kesehatan, Hendro Santoso. Ditujukan kepada: Tujuan perubahan adalah menyesuaikan nomenklatur dengan [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":3219,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","_thinkrank_schema_form_data":"","_thinkrank_selected_schema_type":"","_thinkrank_additional_schemas":"","_thinkrank_schema_disabled":"","_thinkrank_canonical_url":"","_thinkrank_og_title":"","_thinkrank_og_description":"","_thinkrank_og_image":"","_thinkrank_twitter_title":"","_thinkrank_twitter_description":"","_thinkrank_twitter_image":"","_thinkrank_imported_from":"","_thinkrank_focus_keywords":[],"_thinkrank_focus_keyword":"","_thinkrank_robots_meta_enabled":0,"_thinkrank_robots_meta":"[]","_thinkrank_advanced_robots_meta":"[]","_thinkrank_exclude_from_search":0,"_thinkrank_exclude_from_archives":0,"_thinkrank_primary_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3217","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.5 - aioseo.com -->\n\t<meta name=\"description\" content=\"Kemenkes ubah klasifikasi alat kesehatan IVD lewat SE FR.03.01\/E.V\/2204\/2026. 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