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:
| Level | Action | Trigger |
|---|---|---|
| Level 1 | Written warning | Minor labeling or documentation non-compliance |
| Level 2 | NIE suspension | Failure to rectify warnings; CDAKB suspension of LAR |
| Level 3 | NIE revocation + mandatory recall | Serious safety issues; persistent non-compliance; fraud |
If your LAR's CDAKB certificate is suspended or expires, your NIE is automatically frozen — you cannot import or sell new stock until the CDAKB is restored. This is one of the strongest arguments for regular monitoring of your LAR's licence status.
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.