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Directorate of Medical Devices

Overview​

The Directorate of Medical Devices (Direktorat Alat Kesehatan) is the operational unit within the Directorate General of Pharmaceutical and Medical Devices (Dirjen Kefarmasian dan Alat Kesehatan) at Kemenkes. It is the team that directly handles:

  • Technical and administrative evaluation of NIE applications submitted through Regalkes
  • Issuance of marketing authorisations (NIE)
  • Oversight of IDAK/CDAKB distribution compliance
  • Post-market surveillance activities including market sampling
  • Management of adverse event reports and FSCA notifications
  • Coordination with regional health offices for field inspections

Registration Evaluation Process​

When your LAR submits a registration dossier through Regalkes, the Directorate of Medical Devices conducts a two-phase review:

Phase 1: Administrative Review​

Checks that all required documents are present, correctly formatted, and internally consistent. Common reasons for administrative rejection:

  • Letter of Authorization validity shorter than 5 years
  • Name or address inconsistencies across documents (ISO 13485 vs Free Sale Certificate vs LoA)
  • Missing CDAKB certificate for the LAR
  • Incorrect file naming or format in Regalkes upload

Phase 2: Technical Review​

Evaluates the substance of the dossier — device description, intended use, risk management, clinical evidence, labeling compliance, and conformity with applicable standards. The Directorate may issue clarification queries (permintaan klarifikasi) through the Regalkes system. Timely and complete responses are essential to keeping the application on track.

Sanctions and Enforcement​

The Directorate has authority to impose a tiered sanctions regime:

LevelActionTrigger
Level 1Written warningMinor labeling or documentation non-compliance
Level 2NIE suspensionFailure to rectify warnings; CDAKB suspension of LAR
Level 3NIE revocation + mandatory recallSerious safety issues; persistent non-compliance; fraud
NIE automatically linked to LAR's CDAKB - If your LAR's CDAKB certificate is suspended, lapses, or expires, your NIE is immediately frozen and you cannot import, distribute, or sell any products under that NIE, regardless of the NIE's stated expiry date. There is no grace period. This creates a critical dependency: you must monitor your LAR's CDAKB validity at all times and plan renewal at least 3-6 months in advance to avoid market access interruption.

Post-Market Market Sampling​

The Directorate conducts regular unannounced market sampling — purchasing products from hospitals, pharmacies, and medical supply distributors to verify:

  • That the label in the field matches the label approved in Regalkes
  • That the NIE number is correctly printed on all packaging
  • That Bahasa Indonesia content is present and accurate
  • That Halal labeling obligations are being met as deadlines pass

Non-compliant products found during market sampling trigger immediate sanctions procedures.

Post-Market Market Sampling​

"NIE Renewal Requirements - The NIE must be renewed every 5 years. Renewal applications must be submitted through Regalkes at least 6 months before the current NIE expires. Failure to renew on time results in automatic suspension of the NIE and permission to distribute is terminated. Renewal dossiers must include updated GMP certificates, ISO 13485 certificates, and evidence that the device remains compliant with applicable standards."