{"id":1249,"date":"2024-05-08T16:29:32","date_gmt":"2024-05-08T16:29:32","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=1249"},"modified":"2025-02-01T23:40:51","modified_gmt":"2025-02-01T16:40:51","slug":"regulatory-update-coming-up-new-regulation-in-indonesia","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/regulatory-update-coming-up-new-regulation-in-indonesia\/","title":{"rendered":"Upcoming New Regulations in Indonesia!"},"content":{"rendered":"

In 2010, the Indonesian Ministry of Health issued several important regulations concerning the production of medical devices and household products. These include PERMENKES 1189\/VIII\/2010, which pertains to medical device production; PERMENKES 1191\/VIII\/2010, which addresses medical device distributors; and PERMENKES 70\/2010, which focuses on household producers. With the introduction of the latest presidential regulations, No. 91\/2017 and 24\/2018, aimed at business acceleration and the integration of electronic licensing services, the Ministry of Health has implemented a new regulatory framework to streamline licensing services in the health sector, thereby expediting the medical equipment licensing process in Indonesia.<\/p>\n\n\n\n

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Under the previous regulations, companies involved in manufacturing and distributing medical devices were required to obtain both a manufacturing license and a medical equipment distributor license. This process involved an investigation by regional health offices based on the company\u2019s domicile. However, the new regulation PMK 26\/2018 shifts the investigative responsibility to the central government (Ministry of Health), further accelerating the licensing process. Additionally, the new regulations have reduced the requirements, shortened timelines, and established a five-year validity period for distributor licenses.<\/p>\n\n\n\n

The Ministry of Health oversees approximately 33 health sectors, which include product approval for medical devices, in vitro diagnostics (IVD), household products, distribution<\/p>\n\n\n\n

In line with the presidential regulations concerning integrated electronic licensing services, the Indonesian government launched a new system in July 2018 called OSS (Online Single Submission). This system mandates that all permits and licensing processes, including medical device licensing, be conducted through a single-window approach.<\/p>\n\n\n\n

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While it remains uncertain when these regulations will be fully implemented across all health sectors, changes are actively underway. According to regulation 26\/2018, Chapter IV, three heads of government are authorized to issue permits: the Ministry of Health, regional governors, and regents or mayors. Specifically, the Ministry of Health is responsible for product approval licensing, manufacturing licenses, distribution licenses, and GDPMD certification.<\/p>\n\n\n\n

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Contact Us<\/strong><\/a><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

Pada tahun 2010, Kementerian Kesehatan Republik Indonesia mengeluarkan beberapa regulasi penting terkait produksi alat kesehatan dan produk rumah tangga. Regulasi tersebut meliputi PERMENKES 1189\/VIII\/2010 yang berkaitan dengan produksi alat kesehatan; PERMENKES 1191\/VIII\/2010 yang mengatur distributor alat kesehatan; dan PERMENKES 70\/2010 yang fokus pada produsen rumah tangga. Dengan diperkenalkannya regulasi presiden terbaru, No. 91\/2017 dan 24\/2018, […]<\/p>\n","protected":false},"author":1,"featured_media":2564,"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-1249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t