CDAKB - Insightof Consulting

CDAKB Certification Service

Ensuring Comprehensive SOP Implementation in Medical Device Distribution

Comprehensive SOP Implementation

CDAKB certification ensures your company meets strict standards across all aspects of the distribution process, from receiving goods to handling rejected products.

Regulatory Compliance

Required by Indonesian law for companies distributing medical devices

Enhanced Market Access

Certification boosts your credibility and access to Indonesia's healthcare sector.

Quality Control

A commitment to upholding safety and quality across the distribution chain.

What is CDAKB?

CDAKB, or Cara Distribusi Alat Kesehatan yang Baik, is a certification that focuses on the development and proper implementation of Standard Operating Procedures (SOPs) within companies distributing medical devices. It ensures that all aspects of distribution meet regulatory standards, ensuring the safety, quality, and traceability of products.

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How to Obtain Your IDAK

Evaluate Your Current SOPs

Review existing procedures and identify gaps in compliance with CDAKB standards.

Prepare Documents

Ensure all necessary documents are in place, including detailed SOPs for each area of your distribution operations.

Submit Your Application

Apply through the Ministry of Health / Kemenkes (Regalkes).

Audit

Auditors will review your SOPs, facilities, and operational procedures to ensure compliance with CDAKB standards.

CAPA Implementation

If any issues are identified during the audit, you will be required to take corrective and preventive actions (CAPA) to address non-conformities. This may involve updating SOPs, staff training, or facility improvements.

Issuance of CDAKB Certificate

After passing the audit and review process, you will receive your CDAKB certificate, signifying compliance with all regulatory requirements.

Basic Document Requirement

Notarial Deed of Company Establishment

Business Identification Number (NIB) – 46691

Taxpayer Identification Number (NPWP)

Building/Warehouse Floor Plan and Equipment

Pictures of Workspaces and Warehouse

SOP for Storage, Reception and Distribution of Goods

CDAKB Training Certificate for Technical Responsible Person (PJT)

Have any questions about CDAKB Certification?

We’re here to help! Our team of experts provides clear guidance and support to ensure a seamless registration process, from understanding regulations to obtaining approval.

INSIGHTOF Consulting

Your Regulatory Experts

Address

Wisma PMI 6th Floor Jl. Wijaya I No.63, RT.8/RW.1, Petogogan, Kec. Kby. Baru, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta 12160

Mail Address

marketing@insightof.co.id

+62 897 6470 070

Phone

(021) 7279 3812

Working Hours

Mon to Fri : 08:00 AM – 17:00 PM

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