Industry Findings: Indonesia’s regulatory overhaul and the Health Omnibus implementing regulations are forcing suppliers to re-evaluate registration strategies and local-presence investments. Government Regulation No. 28 of 2024 (GR-28) widened the scope of health-sector oversight and clarified device registration pathways, increasing emphasis on local-agent responsibilities and technical dossier quality — a structural change that pushes vendors to strengthen local QA and compliance capabilities.
Industry Progression: The most market-moving development is the recent Permenkes update (Permenkes 11/2025) which revises device and IVD registration timelines and procedural steps (2025). This update alters approval expectations and timeline management for new product entries and encourages vendors to pre-position dossiers or partner with local manufacturers to speed market access — converting regulatory change into accelerated in-market deployments when registrations are managed proactively.
Industry Player Insights: Some of the players operating in the Indonesia industry are Siemens Healthineers, Roche Diagnostics, Abbott, and Kalbe Farma etc. Vendor behaviour is evolving: global suppliers such as Siemens and Roche maintain tender teams and local service hubs, Abbott expands distribution for POC kits, while Kalbe Farma’s investments in diagnostic reagent and distribution channels (2023–2024 activity) give domestic partners more weight in procurement. Combined, these shifts shorten go-to-market paths for both imported and locally produced devices.