{"id":1272,"date":"2024-05-11T12:46:53","date_gmt":"2024-05-11T12:46:53","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=1272"},"modified":"2025-02-01T23:37:22","modified_gmt":"2025-02-01T16:37:22","slug":"regulatory-update-pengumuman-pendaftaran-izin-edar-notifikasi-produk-pkrt-kelas-1-dan-2","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/regulatory-update-pengumuman-pendaftaran-izin-edar-notifikasi-produk-pkrt-kelas-1-dan-2\/","title":{"rendered":"Announcement of Registration of PKRT Product Notification Edar Permit Class 1 and 2"},"content":{"rendered":"<p class=\"has-text-align-center has-large-font-size\"><strong>ANNOUNCEMENT<\/strong><\/p>\n\n\n\n<p>In accordance with Permenkes 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector, and following the issuance of notification letter number UM.01.05\/5\/0024\/2022 regarding the enforcement of the Circular Permit of Notification for Medical Devices and Household Chemical Substances (PKRT), which has been in effect since January 10, 2022, we would like to inform you about several important considerations for fulfilling the requirements for the distribution permit for notifications.<\/p>\n\n\n\n<p>Currently, new applications for a distribution permit for Class 1 and Class 2 PKRT notifications must be submitted through the OSS RBA application. This can be done using your OSS RBA user ID and password at the following link: <a href=\"http:\/\/oss.go.id\">http:\/\/oss.go.id<\/a>. For applications concerning extensions, changes, or extensions with changes, please use the Regalkes application with your Regalkes user ID and password at <a href=\"http:\/\/regalkes.kemkes.go.id\">http:\/\/regalkes.kemkes.go.id<\/a>.<\/p>\n\n\n\n<p>The pre-market requirements for distribution permits for Class 1 and Class 2 Household notifications include both administrative documents and product formulas. Additionally, technical documents must be completed in the Product Conformity Document (DKP) electronically and must be stored as required.<\/p>\n\n\n\n<p>Changes that necessitate the registration of a new application for a notification distribution permit include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Change of product name<\/li>\n\n\n\n<li>Change of importer<\/li>\n\n\n\n<li>Change of factory\/manufacturer<\/li>\n\n\n\n<li>Change of factory\/manufacturer address<\/li>\n\n\n\n<li>Specification changes<\/li>\n\n\n\n<li>Change of raw material\/formula<\/li>\n\n\n\n<li>Changes in company ownership, such as mergers or acquisitions<\/li>\n<\/ul>\n\n\n\n<p>Certain changes do not require a new application for the notification distribution permit, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Change of factory name (without changing the address)<\/li>\n\n\n\n<li>Change of principal name<\/li>\n\n\n\n<li>Changes in packaging size<\/li>\n\n\n\n<li>Changes in packaging containers<\/li>\n<\/ul>\n\n\n\n<p>For the validity of distribution permits for Class 1 and Class 2 Household notifications, the following certificates do not need to be submitted regarding marking:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Change notification letter<\/li>\n\n\n\n<li>Certificate of inclusion of halal logo<\/li>\n\n\n\n<li>Promotion certificate (unless combining several products with different NIEs in the form of bundling)<\/li>\n<\/ul>\n\n\n\n<p>Each statement submitted on the Regalkes website must include a valid payment of Rp. 10,000, in compliance with Chapter IX of the criminal provisions of Law No. 10 of 2020 concerning Stamp Duty.<\/p>\n\n\n\n<p>We hope this notification is clear and informative. Please pay attention to all parties involved. Thank you.<\/p>\n\n\n\n<p>Source: <a href=\"http:\/\/regalkes.kemkes.go.id\/index.php\">http:\/\/regalkes.kemkes.go.id\/index.php<\/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 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>PENGUMUMAN Sehubungan dengan Permenkes 14 Tahun 2021 tentang Standar Kegiatan Usaha dan Produk dalam Pelaksanaan Perizinan Berbasis Risiko di Sektor Kesehatan, dan setelah dikeluarkannya surat pemberitahuan nomor UM.01.05\/5\/0024\/2022 mengenai penegakan Izin Pemberitahuan Alat Kesehatan dan Bahan Kimia Rumah Tangga (PKRT), yang telah berlaku sejak 10 Januari 2022, kami ingin menginformasikan beberapa hal penting terkait pemenuhan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2554,"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-1272","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\/5.-PKRT-IN-.jpg",771,421,false],"landscape":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN-.jpg",771,421,false],"portraits":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN-.jpg",771,421,false],"thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--150x150.jpg",150,150,true],"medium":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--300x164.jpg",300,164,true],"large":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN-.jpg",771,421,false],"1536x1536":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN-.jpg",771,421,false],"2048x2048":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN-.jpg",771,421,false],"trp-custom-language-flag":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--18x10.jpg",18,10,true],"woocommerce_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--300x300.jpg",300,300,true],"woocommerce_single":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--600x328.jpg",600,328,true],"woocommerce_gallery_thumbnail":["https:\/\/derayglobalutama.com\/wp-content\/uploads\/2024\/05\/5.-PKRT-IN--100x100.jpg",100,100,true]},"rttpg_author":{"display_name":"deraygu.com","author_link":"https:\/\/derayglobalutama.com\/en\/author\/deraygu-com\/"},"rttpg_comment":1,"rttpg_category":"<a href=\"https:\/\/derayglobalutama.com\/en\/category\/blog\/\" rel=\"category tag\">Blog<\/a>","rttpg_excerpt":"PENGUMUMAN Sehubungan dengan Permenkes 14 Tahun 2021 tentang Standar Kegiatan Usaha dan Produk dalam Pelaksanaan Perizinan Berbasis Risiko di Sektor Kesehatan, dan setelah dikeluarkannya surat pemberitahuan nomor UM.01.05\/5\/0024\/2022 mengenai penegakan Izin Pemberitahuan Alat Kesehatan dan Bahan Kimia Rumah Tangga (PKRT), yang telah berlaku sejak 10 Januari 2022, kami ingin menginformasikan beberapa hal penting terkait pemenuhan&hellip;","_links":{"self":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1272","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=1272"}],"version-history":[{"count":3,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1272\/revisions"}],"predecessor-version":[{"id":2373,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/posts\/1272\/revisions\/2373"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media\/2554"}],"wp:attachment":[{"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/media?parent=1272"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/categories?post=1272"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/derayglobalutama.com\/en\/wp-json\/wp\/v2\/tags?post=1272"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}