Why CDAKB Comes After IDAK
After obtaining the IDAK (Izin Distributor Alat Kesehatan) license, a company is legally allowed to distribute medical devices in Indonesia. However, IDAK alone is not sufficient to proceed with product registration.
The Indonesian Ministry of Health (Kementerian Kesehatan) requires distributors to demonstrate that their operations comply with Good Distribution Practice (GDP) standards before granting market access.
This requirement is fulfilled through:
👉 CDAKB (Cara Distribusi Alat Kesehatan yang Baik)
Without CDAKB certification:
NIE (Nomor Izin Edar) applications cannot proceed
Products cannot be listed in the LKPP E-Catalogue
Distribution activities are considered non-compliant at an operational level
What is CDAKB Certification?
CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is the Indonesian regulatory standard governing the proper distribution of medical devices.
It is enforced by the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes) under the Ministry of Health.
Core Objective:
To ensure that medical devices:
Maintain quality and integrity during storage and transport
Are traceable throughout the supply chain
Can be recalled effectively if safety issues arise
Regulatory Basis (Indonesia MoH Framework)
CDAKB implementation is aligned with:
Ministry of Health distribution regulations for medical devices
GDP principles adapted for Indonesia
Requirements enforced through the Regalkes system
Recent regulatory updates have made CDAKB:
Mandatory for new NIE applications
Required for participation in government procurement systems (LKPP)
Core CDAKB Requirements (Based on Audit Criteria)
CDAKB certification is granted only after verifying that your distribution system is fully compliant. Authorities focus on the following areas:
1. Quality Management System (QMS)
You must establish a documented system covering:
Standard Operating Procedures (SOPs)
Deviation handling
Corrective and preventive actions (CAPA)
Complaint handling
👉 Documentation must reflect actual operations, not generic templates.
2. Warehouse & Storage Control
The facility must demonstrate:
Clearly defined zones:
Receiving
Quarantine
Released products
Environmental control (temperature/humidity if required)
Protection against contamination or damage
👉 Inspectors verify physical layout vs documented process
3. Traceability & Distribution Records
You must maintain systems to:
Track batch/lot numbers
Record distribution history
Identify affected products in case of recall
👉 This is one of the most critical compliance areas.
4. Personnel & PJT Responsibility
Requirements include:
Appointment of a PJT (Penanggung Jawab Teknis)
Evidence of qualifications
Training records for all relevant staff
👉 The PJT is legally responsible for ensuring compliance.
5. Documentation & Record Control
Authorities require:
Controlled SOPs
Training logs
Distribution records
Audit trail
👉 Missing or inconsistent documentation is a common audit failure
CDAKB Audit Checklist (Detailed & Practical)
Before applying, ensure readiness in all areas below:
📄 Legal & Company Documents
Valid IDAK license
NIB (Business Identification Number)
Organizational structure
🏭 Facility Requirements
Warehouse layout plan
Defined storage zones
Environmental monitoring system
Cleaning and maintenance records
👥 Personnel
PJT appointment letter
Qualification certificates
Staff training records
📊 Systems & Procedures
SOPs for:
Storage
Distribution
Complaint handling
Recall
Traceability system
📦 Operational Records
Incoming/outgoing logs
Batch tracking
Product handling records
CDAKB Certification Process (Step-by-Step)
Step 1: Internal Preparation & Gap Assessment
Before applying, companies must:
Align SOPs
Prepare documentation
Ensure facility readiness
👉 Most failures occur due to incomplete preparation
Step 2: Application Submission (Sertifikasi Alkes Portal)
Submit CDAKB application via official system
Upload required documentation
Step 3: Administrative Review
Authorities verify:
Completeness of documents
Consistency with IDAK and OSS data
Step 4: On-Site Audit
Inspectors evaluate:
Warehouse conditions
SOP implementation
Staff awareness
Record accuracy
👉 This is the most critical stage
Step 5: Audit Findings (CAPA Phase)
If issues are identified:
Company must submit corrective actions
Evidence of compliance must be provided
Step 6: Certification Issuance
Once compliant:
CDAKB certificate is issued
Company becomes eligible for NIE submission
CDAKB Timeline (Realistic Expectation)
👉 Total: 1 to 3 months
Common Reasons for CDAKB Audit Failure
Based on regulatory patterns:
Lack of traceability system
SOPs not aligned with operations
Untrained personnel
Poor warehouse zoning
Documentation inconsistencies
👉 These issues lead to:
Audit rejection
Delays in NIE submission
Practical Insight: Why CDAKB is a Critical Bottleneck
Unlike IDAK, CDAKB:
Requires real operational readiness
Cannot be bypassed with documentation alone
Directly impacts product registration timelines
👉 Many companies delay market entry because CDAKB is not prepared in parallel with IDAK.
How OMC Medical Supports CDAKB Compliance
CDAKB certification requires alignment between documentation, facility, and operations. OMC Medical provides structured support to ensure compliance without delays:
Preparation of CDAKB-compliant SOPs
Gap assessment before audit
Warehouse compliance guidance
Documentation review and correction
Support during audit and CAPA phase
👉 This ensures:
Reduced audit risk
Faster certification
Smooth transition to NIE registration
🚀 Next Step: Move Toward Product Registration (NIE)
Once CDAKB certification is obtained, the next stage is:
This is where your medical device receives official approval for sale in Indonesia.
