{"id":20874,"date":"2022-04-29T12:32:45","date_gmt":"2022-04-29T10:32:45","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20874"},"modified":"2022-04-29T12:32:45","modified_gmt":"2022-04-29T10:32:45","slug":"indonesia-simplified-registration-process-for-class-a-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/04\/29\/indonesia-simplified-registration-process-for-class-a-devices\/","title":{"rendered":"INDONESIA: simplified registration process for class A devices"},"content":{"rendered":"\n<p>On 10 January 2022, the Indonesian Ministry of\nHealth, following Regulation 14 of 2021, announced that it had introduced a <strong>simplified\nregistration process<\/strong> for <strong>certain Class A Medical Devices<\/strong>.<\/p>\n\n\n\n<p>It is no longer required, for these products,\nto follow the complete registration process. It is sufficient a <strong>notification<\/strong>\nwhich can be submitted via the <strong>online registration system<\/strong> on the website\n<a href=\"http:\/\/regalkes.kemkes.go.id\/\">regalkes.kemkes.go.id<\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/04\/indonesia-nuovo-percorso-registrazione-dispositivi-medici-classe-a-1024x536.jpg\" alt=\"INDONESIA: simplified registration process for class A devices \" class=\"wp-image-20863\"\/><figcaption>INDONESIA: simplified registration process for class A devices <\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Which Medical Devices can be\nregistered via the simplified process in Indonesia?<\/strong><\/h2>\n\n\n\n<p>At the time being, only some <strong>low-risk Class A Medical Devices<\/strong>, may be subject to the simplified notification procedure, among them:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li> crutches <\/li><li> dental floss <\/li><li> elastic bandages <\/li><li> mechanical wheelchairs <\/li><li> medical disposable bed linen <\/li><li> mechanical walkers <\/li><li> manual breast pumps <\/li><li> teething rings <\/li><li> ice bags <\/li><li> limb and trunk braces <\/li><li> medical insoles <\/li><li> ophthalmic visors <\/li><li> patient scale<\/li><\/ul>\n\n\n\n<p>If the Class A medical devices listed above\nhave existing registrations, these remain valid until their expiration date. However,\nin the case of product changes requiring notification, a new device\nregistration must be made using the simplified procedure.<\/p>\n\n\n\n<p>With the simplified procedure, notification <strong>times<\/strong>\nare significantly reduced, making it easier to place many low-risk devices on\nthe Indonesian market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you\nneed any kind of support to market your Medical Devices in Indonesia?<\/strong><\/h2>\n\n\n\n<p>Thanks to the cooperation with partner\ncompanies in several extra European countries, our experts can support you in\nthe preparation activities for the notification and registration of Medical\nDevices with local Regulatory Authorities.<\/p>\n\n\n\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">&gt;&gt;&gt; Find out how we can help you market your products in Indonesia.<\/a><\/strong><\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Contact our Customer Service (si apre in una nuova scheda)\">Contact our Customer Service<\/a><\/strong> for further information on the service.<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p><a href=\"http:\/\/regalkes.kemkes.go.id\/\">Online registration system, Kementerian Kesehatan Republik Indonesia, 10\nJanuary 2022<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/regalkes.kemkes.go.id\/index.php\/home\/fileDownload\/BERITA_FILE.pdf\/1000863\">Online Registration System Guide,\nDirectorate of General Pharmaceutical Service and Medical Device, 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 10 January 2022, the Indonesian Ministry of Health, following Regulation 14 of 2021, announced that it had introduced a simplified  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-20874","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>INDONESIA: simplified registration process for class A devices<\/title>\n<meta name=\"description\" content=\"Indonesian Ministry of Health had introduced a simplified registration process for certain Class A Medical Devices\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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