{"id":3022,"date":"2026-08-28T08:00:22","date_gmt":"2026-08-28T01:00:22","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=3022"},"modified":"2026-08-24T08:23:01","modified_gmt":"2026-08-24T01:23:01","slug":"permenkes-11-2025-panduan-lengkap-untukpelaku-bisnis-alat-kesehatan","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/permenkes-11-2025-panduan-lengkap-untukpelaku-bisnis-alat-kesehatan\/","title":{"rendered":"Ministry of Health Regulation No. 11\/2025: A Comprehensive Guide for Medical Device Businesses"},"content":{"rendered":"

Permenkes 11\/2025 is now fully in effect<\/h2>\n\n\n\n

After a transition period, Permenkes 11\/2025 is now fully in effect for all medical device\nbusinesses in Indonesia. We are still finding long-time clients whose internal processes have not\ncaught up, and this guide is meant to help close that gap.<\/p>\n\n\n\n

What Permenkes 11\/2025 covers<\/h2>\n\n\n\n

Broadly, this regulation strengthens several areas that were previously loosely enforced in\npractice, particularly around post-market surveillance and clarity of license holder\nresponsibility.<\/p>\n\n\n\n

Five key changes businesses need to know<\/h2>\n\n\n\n
    \n
  1. Sharper post-market surveillance enforcement<\/strong>
    Post-market surveillance is now treated as an active obligation rather than an annual formality.\nCompanies are expected to run ongoing monitoring, not assemble a report close to the deadline.<\/li>\n\n\n\n
  2. More detailed documentation requirements<\/strong>
    For certain risk classes, the documentation required at registration and renewal is more detailed than under the previous rules.<\/li>\n\n\n\n
  3. Adjusted authority for Local Authorized Representatives<\/strong>
    Some types of reporting previously fully delegable to a LAR now have clearer authority limits,\naffecting how foreign manufacturers coordinate with their local partners.<\/li>\n\n\n\n
  4. A clearer link between CDAKB and license holder obligations<\/strong>
    The regulation reaffirms that holding CDAKB certification and carrying Izin Edar holder\nresponsibility are interconnected, especially for entities playing a dual role.<\/li>\n\n\n\n
  5. The transition period has ended<\/strong>
    Companies still operating under the old rules are now at risk of non-compliance, since the\ntransition window has closed.<\/li>\n<\/ol>\n\n\n\n

    Who is most affected<\/h2>\n\n\n\n

    The companies that most need to review their internal processes are manufacturers with Class C and D products, entities acting as both license holder and distributor, and companies whose\npost-market reporting systems are still manual or unscheduled.<\/p>\n\n\n\n

    Steps we recommend<\/h2>\n\n\n\n
      \n
    1. Review your current post-market surveillance process end to end;<\/li>\n\n\n\n
    2. Check whether registration documentation meets the latest standard;<\/li>\n\n\n\n
    3. Re-clarify reporting authority with your LAR, if applicable;<\/li>\n\n\n\n
    4. Make sure CDAKB certification and Izin Edar status stay aligned, not treated as two separate\nprocesses;<\/li>\n<\/ol>\n\n\n\n

      Conclusion<\/h2>\n\n\n\n

      Permenkes 11\/2025 does not change the basic principles of Indonesian medical device\nregulation, but it sharpens and tightens how they are enforced. Companies that skip reviewing\ntheir internal processes risk discovering the gap during an audit or license renewal, a far more\nexpensive moment to fix it.<\/p>\n\n\n\n

      If your company has not done this review yet, we can help. Reach us at info@derayglobalutama.com.<\/p>\n\n\n\n

      \n
      Contact Us<\/strong><\/a><\/div>\n<\/div>\n\n\n\n

      <\/p>","protected":false},"excerpt":{"rendered":"

      Permenkes 11\/2025 kini berlaku penuh Setelah melalui masa transisi, Permenkes 11\/2025 sekarang berlaku penuh bagi seluruh pelaku bisnis alat kesehatan di Indonesia. Kami masih menemukan klien lama yang proses internalnya belum disesuaikan dengan aturan baru ini, dan panduan ini disusun untuk membantu meluruskan itu. Apa yang diatur Permenkes 11\/2025 Secara umum, regulasi ini memperkuat beberapa […]<\/p>\n","protected":false},"author":3,"featured_media":3023,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_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_primary_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3022","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\n\t\t\n\t\t