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Ministry of Health — Kemenkes

Overview​

The Kementerian Kesehatan Republik Indonesia (Ministry of Health, abbreviated Kemenkes) is the primary regulatory authority for medical devices in Indonesia. For manufacturers seeking to place a medical device on the Indonesian market, Kemenkes is the competent authority you interact with — it issues the NIE (Nomor Izin Edar), operates the Regalkes registration portal, and conducts market surveillance.

Kemenkes operates under the President of the Republic through the Cabinet system. The specific operational unit responsible for medical devices is the Directorate General of Pharmaceutical and Medical Devices (Direktorat Jenderal Kefarmasian dan Alat Kesehatan).

Key Functions Relevant to Medical Device Manufacturers​

FunctionDescription
NIE IssuanceIssues the Nomor Izin Edar — the mandatory marketing authorisation for all medical devices
Regalkes PortalOperates and maintains Indonesia's online device registration system
Technical EvaluationConducts administrative and technical review of registration dossiers
IDAK OversightOversees the IDAK (distribution licence) system via OSS
CDAKB InspectionsConducts Good Distribution Practice inspections of local distributors and LARs
Market Surveillance"Market sampling" — physical inspection of products available in hospitals and pharmacies to verify label compliance and NIE validity
Post-Market OversightReceives adverse event reports, manages NIE renewals, and issues sanctions for non-compliance

Organisational Structure (Device-Relevant)​

Kemenkes (Ministry of Health)
└── Dirjen Kefarmasian dan Alat Kesehatan
    (Directorate General of Pharmaceutical and Medical Devices)
    ├── Directorate of Medical Devices
    │   ├── Pre-market evaluation (NIE, registration)
    │   └── Post-market surveillance
    └── Directorate of Pharmaceutical Goods
        └── (Pharmaceutical products — separate stream)

Regalkes — The Digital Interface​

All medical device registrations are processed through the Regalkes portal (regalkes.kemkes.go.id). Kemenkes developed Regalkes as the single digital platform for:

  • Submitting new device registrations
  • Paying PNBP (non-tax government revenue) fees
  • Responding to evaluator clarification requests
  • Managing NIE renewals and change notifications
  • Monitoring application status in real time
caution

Regalkes undergoes periodic scheduled maintenance shutdowns (for example, a closure was planned for December 2024). Plan submissions with buffer time around known maintenance periods.

Contacting Kemenkes​

For device registration matters:

  • Regalkes portal: regalkes.kemkes.go.id
  • Official Kemenkes website: www.kemkes.go.id
  • Formal correspondence is typically conducted through the Regalkes system and the LAR's registered account
note

Kemenkes communications are primarily in Bahasa Indonesia. Engaging a local regulatory affairs professional or LAR to manage correspondence is strongly recommended.