{"id":3197,"date":"2026-10-21T21:52:01","date_gmt":"2026-10-21T14:52:01","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=3197"},"modified":"2026-10-21T21:52:03","modified_gmt":"2026-10-21T14:52:03","slug":"panduan-lengkap-izin-edar-alat-kesehatan-berbasis-perangkat-lunak-di-indonesia","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/panduan-lengkap-izin-edar-alat-kesehatan-berbasis-perangkat-lunak-di-indonesia\/","title":{"rendered":"Medical Device Software Registration Guide:\nIndonesia 2026"},"content":{"rendered":"<h2 class=\"wp-block-heading\">What Is Medical Device Software?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Indonesia's government has established official guidelines for managing digital health product registration. The Ministry of Health Regulation Number HK.01.07\/MENKES\/ 951\/2026, enacted on September 7, 2026, governs how medical software, artificial intelligence applications, and health software must be developed, tested, and distributed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Why does this matter? Digital technology has become integral to healthcare delivery. From glucose monitoring apps to AI-driven diagnostic systems, health software influences medical decisions daily. This regulation ensures products are safe, effective, and high-quality before reaching doctors and patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Three Main Categories of Digital Health Devices<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Software as a Medical Device (SaMD)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">SaMD is standalone software that operates independently without requiring specialized hardware. Examples include :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mobile apps for diabetic patients to monitor glucose levels;<\/li>\n\n\n\n<li>Medical image analysis software that doctors use to interpret X-ray images;<\/li>\n\n\n\n<li>Systems that predict heart attack risk based on digital ECG data.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Key characteristics: Does not require specialized medical hardware to operate and can run on standard computers, tablets, or smartphones.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Software in Medical Device (SiMD)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">SiMD is embedded within medical hardware and controls how that device functions. Examples include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Software that operates MRI or CT scan machines;<\/li>\n\n\n\n<li>Automated systems in ventilators for respiratory support;<\/li>\n\n\n\n<li>Software in pacemakers that regulates patient heartbeat<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Key characteristics: Cannot be used separately from the hardware and functions to control medical device operations.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Artificial Intelligence and Machine Learning Medical Devices (AI\/ML-MD)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">This rapidly growing category includes products using machine learning or AI to analyze health data and provide recommendations. Examples include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Systems that automatically analyze radiological images<\/li>\n\n\n\n<li>Applications that identify patterns in patient health data<\/li>\n\n\n\n<li>AI chatbots or assistants helping medical professionals make clinical decisions<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The government emphasizes: AI in medical devices is only considered a \"medical device\" if its output is truly used for medical purposes (diagnosis, monitoring, therapy), not merely administrative functions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Registration Requirements: What Must Be Fulfilled<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Who Needs Registration?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers selling digital health products in Indonesia must obtain market authorization from the Ministry of Health. Distributors must also register and comply with good distribution standards.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Required Documentation<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">1. Quality Management System Documentation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Every manufacturer must demonstrate a system for quality control. International standards that can serve as reference include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485 (quality management for medical devices)<\/li>\n\n\n\n<li>ISO 62304 (software lifecycle process for medical devices)<\/li>\n\n\n\n<li>IEC 62366 (usability engineering for medical devices)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Essentially: manufacturers must prove they have rigorous processes to ensure product safety and functionality.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Verification and Validation Documentation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">This is evidence that the product has been properly tested. Must include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Information about the software version tested;<\/li>\n\n\n\n<li>How data moves between systems (if connected with other systems);<\/li>\n\n\n\n<li>Cybersecurity evidence (protection from attacks);<\/li>\n\n\n\n<li>Complete test results<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. Clinical Evidence Documentation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">For certain products, manufacturers must submit evidence that the product truly functions as claimed. Evidence may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Scientific literature supporting the product;<\/li>\n\n\n\n<li>Comparison with similar products already on the market;<\/li>\n\n\n\n<li>Clinical trial results (especially for new claims or critical features).<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The government recognizes not all products require expensive clinical trials. For lowrisk products, scientific literature is sufficient.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Labels and Instructions for Use<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Products must include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product name and version number;<\/li>\n\n\n\n<li>Manufacturer identity;<\/li>\n\n\n\n<li>Clear intended use statements;<\/li>\n\n\n\n<li>Easy-to-understand instructions for use;<\/li>\n\n\n\n<li>Safety information and warnings.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">AI and Machine Learning: Special Requirements<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">For products using AI or machine learning, the government adds extra requirements:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Dataset Documentation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers must explain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>What data was used to train the system (medical images? patient data? physiological signals?)<\/li>\n\n\n\n<li>How much data (dataset size);<\/li>\n\n\n\n<li>How data was cleaned and processed;<\/li>\n\n\n\n<li>Whether bias is possible (for example, did data come from only one hospital or specific population?).<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Model Documentation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers must explain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>What type of AI\/machine learning was used<\/li>\n\n\n\n<li>How the model was trained and validated<\/li>\n\n\n\n<li>Accuracy results and other performance parameters<\/li>\n\n\n\n<li>Model limitations (when might the model fail?)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Continuous Learning<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">If the product can learn from new data during use (continuous learning), manufacturers must demonstrate:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>How the system detects unexpected events;<\/li>\n\n\n\n<li>How new data is safely integrated;<\/li>\n\n\n\n<li>Mechanisms to revert to previous versions if problems occur.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Regulatory Sandbox: Space for Innovation<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Indonesia's government understands that innovative products may not have all ideal clinical evidence. For this, there is a \"regulatory sandbox\" mechanism.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is a controlled trial in hospitals or certain health facilities before broad launch. Requirements include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product must have reached technology readiness level 9 (system proven to work in real conditions)<\/li>\n\n\n\n<li>Trials conducted at qualifying health facilities<\/li>\n\n\n\n<li>Trial data used to complete clinical evidence<\/li>\n\n\n\n<li>Local clinical validation results must be submitted within 1 year of authorization<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This mechanism creates opportunities for local innovators to test their products while ensuring patient safety.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Registration Holder Obligations<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">After obtaining authorization, manufacturers cannot simply let products run themselves. They have ongoing responsibilities:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Data Security and Privacy<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Protect patient health data from unauthorized access;<\/li>\n\n\n\n<li>Encrypt data in transit and at rest;<\/li>\n\n\n\n<li>Maintain strict cybersecurity protocols;<\/li>\n\n\n\n<li>Report any data breaches.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Transparency and Accountability<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Inform users how the product works<\/li>\n\n\n\n<li>Be clear about system limitations and constraints<\/li>\n\n\n\n<li>Do not hide information about how AI makes decisions<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. Ethics in AI Development<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">For AI products, manufacturers must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Avoid discrimination and bias that harms patients;<\/li>\n\n\n\n<li>Ensure systems are inclusive for all patient groups;<\/li>\n\n\n\n<li>Respect user humanity and privacy;<\/li>\n\n\n\n<li>Maintain patient safety as the top priority.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Integration with National Systems<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers commit that data output from their products can integrate with the National Health Information System (SIKN\/SATUSEHAT). This supports:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Patient care continuity;<\/li>\n\n\n\n<li>National health research;<\/li>\n\n\n\n<li>Public health monitoring;<\/li>\n\n\n\n<li>Data-driven health policy.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Changes to Market Authorization: When to Report<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Digital health products evolve. New features, bug fixes, security updates emerge. The question: when must manufacturers report changes to the Ministry of Health?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Changes Requiring New Authorization<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Changes affecting indicated use or clinical performance:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Algorithm modifications that change diagnostic accuracy<\/li>\n\n\n\n<li>New clinical features affecting medical decisions<\/li>\n\n\n\n<li>Changes that increase or decrease system sensitivity<\/li>\n\n\n\n<li>Integration with new devices or systems affecting services<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Example: If a diagnostic app initially detected Disease A with 85% accuracy, then the manufacturer changes the algorithm to 92% accuracy, this is significant and requires new authorization<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Changes Reportable as Authorization Updates<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Changes not affecting safety or clinical performance:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Improved interface appearance;<\/li>\n\n\n\n<li>Enhanced report quality;<\/li>\n\n\n\n<li>New administrative (non-clinical) features;<\/li>\n\n\n\n<li>System performance improvements without changing clinical results.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Example: Improving dashboard appearance or adding better report printing functions.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Gray Area Changes<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">If changes don't clearly fit either category, manufacturers must report to the Ministry of Health with complete data for further evaluation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Post-Launch Oversight<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Market authorization is not the end. The Ministry of Health conducts ongoing oversight:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Routine Report Reviews<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers must report:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>User complaints<\/strong>How the system handles complaints from doctors, hospitals, or patients<\/li>\n\n\n\n<li><strong>Technical monitoring<\/strong>Whether the system continues to work well, cybersecurity vulnerabilities, or other technical issues<\/li>\n\n\n\n<li><strong>Post-market clinical validation<\/strong> Whether system performance matches promises based on real-world usage data<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Local Clinical Validation for Imported Products<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">For foreign products, the government may require  local clinical validation to ensure product effectiveness in Indonesian populations. This is important because:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Genetic or epidemiological patient characteristics may differ<\/li>\n\n\n\n<li>Clinical practices in Indonesia may differ from the country of origin<\/li>\n\n\n\n<li>Local data helps verify the product is truly useful here<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Field Inspections<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Inspections occur at least once per year to verify manufacturers and distributors maintain compliance.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Practical Guide for Industry<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">If you are a developer, startup, or health company wanting to develop digital products in Indonesia, here are initial steps:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Understand your product category: Is it SaMD, SiMD, or AIMD? This determines applicable requirements;<\/li>\n\n\n\n<li>Build quality management systems from the start: Do not wait until near completion. Good processes from the beginning make everything easier.<\/li>\n\n\n\n<li>Document everything: From input data, development processes, to test results. Complete documentation saves time during approval.<\/li>\n\n\n\n<li>For AI products: Pay special attention to datasets (are they representative?), bias mitigation, and continuous monitoring. These are the regulator's primary focus.<\/li>\n\n\n\n<li>Consult with regulatory experts: The regulatory landscape changes. Local experts help you navigate more efficiently.<\/li>\n\n\n\n<li>Consider regulatory sandbox: If your product is innovative but lacks complete clinical evidence, the sandbox can be a bridge to full authorization.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ministry of Health Regulation 951\/2026 is the new foundation for digital health device regulation in Indonesia. This regulation balances  two important things: encouraging innovation in health technology while ensuring safety and quality for patients.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Clear standards build trust. When doctors and patients know that apps or AI systems they use have passed strict verification, they can focus on better healthcare.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For manufacturers and developers, this is opportunity. Indonesia is a large healthcare\nmarket with growing digital needs. By following this regulation well, your product can\nmake real impact for millions of people.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: <a href=\"https:\/\/derayglobalutama.com\/wp-content\/uploads\/2026\/10\/2026kepmenkes951.pdf\" target=\"_blank\" rel=\"noopener\">Keputusan Menteri Kesehatan Republik Indonesia Nomor HK.01.07\/MENKES\/951\/2026 Tentang Pedoman Izin Edar Alat Kesehatan Berbasis Perangkat Lunak<\/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>Apa Itu Alat Kesehatan Berbasis Perangkat Lunak? Pemerintah Indonesia telah menetapkan panduan resmi untuk mengelola izin edar produk kesehatan digital. Keputusan Menteri Kesehatan Nomor HK.01.07\/MENKES\/ 951\/2026, yang disahkan pada 7 September 2026, mengatur bagaimana software medis, aplikasi kecerdasan buatan, dan perangkat lunak kesehatan harus dikembangkan, diuji, dan didistribusikan. Mengapa ini penting? Teknologi digital kini menjadi [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":3199,"comment_status":"closed","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_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-3197","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.3 - aioseo.com -->\n\t<meta name=\"description\" content=\"Panduan izin edar alat kesehatan digital Indonesia. 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