CDAKB — Good Distribution Practice Certificate
What Is CDAKB?
CDAKB stands for Cara Distribusi Alat Kesehatan yang Baik — Indonesia's Good Distribution Practice (GDP) certification for medical device distributors. It is issued by Kemenkes after inspection and verification that the IDAK holder's operations meet the required standards for device distribution.
From July 2024, the CDAKB is mandatory — a valid CDAKB certificate must be held by any entity submitting a new NIE application. Holding an IDAK alone is no longer sufficient.
What CDAKB Covers
Kemenkes evaluates the following areas during CDAKB certification inspections:
| Area | Requirements |
|---|---|
| Quality Management System | Documented QMS including SOPs for all distribution activities |
| Warehouse and storage | Appropriate storage conditions (temperature, humidity, cleanliness), segregation of products |
| Inventory management | Traceability systems for all incoming and outgoing stock |
| Personnel | Qualified responsible person; staff training records |
| Complaint handling | Documented procedure for receiving and investigating complaints |
| Adverse event reporting | Procedure for reporting device-related adverse events to Kemenkes |
| Recall readiness | Documented recall procedure; ability to trace and retrieve all distributed stock |
| Transportation | Procedures ensuring product integrity during delivery |
CDAKB Inspection Process
- IDAK holder applies for CDAKB assessment
- Kemenkes schedules inspection (may be announced or unannounced for re-inspections)
- Inspector evaluates all CDAKB-relevant areas
- Certificate issued on satisfactory assessment (or corrective actions required)
CDAKB is subject to periodic re-inspection. Ongoing unannounced inspections may occur based on compliance history.
Consequences of CDAKB Suspension
CDAKB suspension has immediate and severe consequences for all registered products:
If your LAR's CDAKB certificate is suspended or revoked following a failed inspection:
- All NIEs held by that entity are automatically frozen
- You cannot import new stock against any of those NIEs
- Distribution of existing stock may be restricted
- The freeze persists until the CDAKB is restored
This is why due diligence on your LAR's CDAKB status — and ongoing monitoring — is essential. Request copies of your LAR's current CDAKB certificate and its expiry date before appointment.