{"id":1316,"date":"2024-05-14T12:59:56","date_gmt":"2024-05-14T12:59:56","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=1316"},"modified":"2025-02-01T22:42:38","modified_gmt":"2025-02-01T15:42:38","slug":"izin-edar-alat-kesehatan-indonesia","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/izin-edar-alat-kesehatan-indonesia\/","title":{"rendered":"Indonesian Medical Device Product Approval"},"content":{"rendered":"<h2 class=\"wp-block-heading\">REGULATORY UPDATE | Indonesian Medical Device Product Approval<\/h2>\n\n\n\n<p>In the Republic of Indonesia, obtaining a Medical Device Product Approval is mandatory for marketing Medical Devices, In Vitro Diagnostics (IVDs), and Household Health Supplies. This approval indicates that the medical device has met the required standards for safety, quality, and public benefit.<\/p>\n\n\n\n<p>Companies seeking product approval for medical devices must first access the Online <a href=\"https:\/\/oss.go.id\/en\" target=\"_blank\" rel=\"noopener\" title=\"\">Single Submission (OSS) system <\/a>and obtain an IDAK\/IPAK\/SDAK (permit for distribution of medical devices). The validity of the Medical Device Product Approval is a maximum of five years. If the Medical Device Circulation Permit is not extended before its expiration, the medical device is prohibited from being circulated.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Factors Leading to Invalid Approval<\/strong><\/h3>\n\n\n\n<p>Several factors can result in the invalidation of Medical Device, IVD, and Household Health Supplies Product Approval, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Expiration of the approval date.<\/li>\n\n\n\n<li>Expiration of the Production Certificate.<\/li>\n\n\n\n<li>Expiration of the IPAK validity period.<\/li>\n\n\n\n<li>End of appointment term as a distributor without extension.<\/li>\n\n\n\n<li>Revocation of Product Approval.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Factors Leading to Revocation of Approval<\/strong><\/h3>\n\n\n\n<p>Product Approval can also be revoked under certain conditions, such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Products that pose health risks.<\/li>\n\n\n\n<li>Data discrepancies during the registration process for medical device product approval.<\/li>\n\n\n\n<li>Revocation of the Production Certificate.<\/li>\n\n\n\n<li>Revocation of the IPAK.<\/li>\n\n\n\n<li>Termination of the appointment as a distributor.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Extension of Product Approval<\/strong><\/h3>\n\n\n\n<p>To extend the Product Approval for Medical Devices, IVDs, and Household Health Supplies, the product approval owner must apply for an extension at least nine months before the expiration date. Additionally, the owner must submit production reports electronically through the e-report system prior to applying for an extension.<\/p>\n\n\n\n<p>By following these guidelines, companies can ensure compliance and maintain their product approvals in Indonesia.<\/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 has-custom-font-size is-style-fill has-medium-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color 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>PEMBARUAN REGULASI | Persetujuan Produk Alat Kesehatan di Indonesia Di Republik Indonesia, memperoleh Persetujuan Produk Alat Kesehatan adalah wajib untuk memasarkan Alat Kesehatan, Diagnostik In Vitro (IVD), dan Perlengkapan Kesehatan Rumah Tangga. Persetujuan ini menunjukkan bahwa alat kesehatan tersebut telah memenuhi standar yang diperlukan untuk keselamatan, kualitas, dan manfaat bagi masyarakat. Perusahaan yang ingin mengajukan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2528,"comment_status":"open","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-1316","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\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"landscape":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"portraits":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-150x150.jpg",150,150,true],"medium":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-300x164.jpg",300,164,true],"large":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"1536x1536":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"2048x2048":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN.jpg",771,421,false],"trp-custom-language-flag":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-18x10.jpg",18,10,true],"woocommerce_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-300x300.jpg",300,300,true],"woocommerce_single":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-600x328.jpg",600,328,true],"woocommerce_gallery_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/Persetjuan-Produk-IN-100x100.jpg",100,100,true]},"rttpg_author":{"display_name":"deraygu.com","author_link":"https:\/\/derayglobalutama.com\/en\/author\/deraygu-com\/"},"rttpg_comment":0,"rttpg_category":"<a href=\"https:\/\/derayglobalutama.com\/en\/category\/blog\/\" rel=\"category tag\">Blog<\/a>","rttpg_excerpt":"PEMBARUAN REGULASI | Persetujuan Produk Alat Kesehatan di Indonesia Di Republik Indonesia, memperoleh Persetujuan Produk Alat Kesehatan adalah wajib untuk memasarkan Alat Kesehatan, Diagnostik In Vitro (IVD), dan Perlengkapan Kesehatan Rumah Tangga. Persetujuan ini menunjukkan bahwa alat kesehatan tersebut telah memenuhi standar yang diperlukan untuk keselamatan, kualitas, dan manfaat bagi masyarakat. Perusahaan yang ingin mengajukan&hellip;","_links":{"self":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1316","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/comments?post=1316"}],"version-history":[{"count":4,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1316\/revisions"}],"predecessor-version":[{"id":2420,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1316\/revisions\/2420"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media\/2528"}],"wp:attachment":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media?parent=1316"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/categories?post=1316"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/tags?post=1316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}