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Kemenkes Permenkes

Permenkes No.11/2025

Standards for Risk-Based Health Business and Product Licensing — Medical Device and IVD Provisions
IndonesiaMinistry of HealthRegistrationEffective 2025-10-03
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Permenkes No.11/2025 is the official Kemenkes identifier for “Standards for Risk-Based Health Business and Product Licensing — Medical Device and IVD Provisions”. Permenkes No.11/2025 is the official identifier Kemenkes uses for this instrument.

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Permenkes
Full name
Permenkes No.11/2025
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Registration
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Indonesian
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Dates
Published
2025-10-03
Effective
2025-10-03
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About this regulation

Standards for Risk-Based Health Business and Product Licensing — Medical Device and IVD Provisions

Selected69 complete physical PDF pages: core articles1–40 and promulgation(pp1–23); device/IVD distributor and branch standards(pp253–263); domestic/import device standards(pp387–412); device distribution-practice certificates(pp443–451). Full540-page official PDF and full native extraction retained. Other health-service/drug/PKRT-specific annexes are not represented as device requirements. Art37 preserves specified pending applications; Art39 repeals PMK26/2018 and the corresponding PMK14/2021,8/2022,17/2024 business/product standards.

Permenkes No.11/2025 is the official identifier Kemenkes uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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