CDB Certificate (Good Distribution Practice for Medical Devices)
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What Is a CDB Certificate?
Already have an IDAK license but haven’t obtained CDB certification yet?
CDB (Good Distribution Practice for Medical Devices) is an official standard issued by the Ministry of Health that regulates medical device distribution systems to ensure safety, quality, and proper documentation.
CDB (Good Distribution Practice for Medical Devices) is an official standard established by the Ministry of Health to ensure that every stage of medical device distribution — from receiving and storage to delivery — is carried out safely, with consistent quality, and full accountability.
Simply put: CDB certification demonstrates that your company operates professionally and in full regulatory compliance.
📌 CDB is the updated designation of CDAKB.
Jika sebelumnya dikenal sebagai CDAKB (Good Distribution Practice for Medical Devices), kini istilah yang digunakan adalah CDB, dengan standar prinsip yang sama namun disertai beberapa penyesuaian mekanisme pengajuan dan evaluasi. Artinya: CDAKB dan CDB adalah standar yang sama dalam penerapan mutu distribusi alat kesehatan — hanya nomenklatur dan prosesnya yang diperbarui.
In short, CDB certification is official proof that your company distributes medical devices in accordance with government standards.
🔗 Related Articles:
- Preparation Steps Before Applying for an IDAK License: A Practical Guide for Medical Device Distributors
- Planning to Distribute Medical Devices? Effective Ways to Obtain a Medical Device Distribution License
- Must Know! Notarial Deed of Cooperation with the Responsible Technical Officer (PJT): A New Requirement for Medical Device Distribution
- CDAKB Certification: Understand the Preparations You Need to Make
- The Secret to Successfully Passing CDAKB Certification!
Why Is CDB Certification Important?
Without a CDB certificate, companies may face:
• Ineligibility to participate in medical device procurement tenders
• Warnings or administrative sanctions from the Ministry of Health
• Loss of trust from business partners
CDB certification is official recognition that:
• Your distribution system meets national quality standards
• Medical devices reach end users in safe condition
• Your company is audit-ready at any time
With CDB, your distribution business is not only compliant — but also trusted.
Who Is Required to Obtain a CDB Certificate?
CDB certification is mandatory for:
• Medical device distributors
• Medical device importers
• Medical device suppliers (including branches or distribution partners)
• Companies distributing medical devices under their own name
Companies must also appoint a qualified Technical Person in Charge (PJT).
Legal Basis of CDB
The obligation to implement medical device distribution standards is based on Indonesian government regulations on business licensing and Ministry of Health provisions concerning medical device distribution quality systems.
The certificate is valid for 5 years and must be renewed in accordance with applicable regulations.
Latest CDB Certification Provisions (Regulatory Update 2026)
Key adjustments in the certification mechanism include:
- Change in nomenclature from CDAKB to CDB
- Core quality principles remain the same as CDAKB
- Companies holding ISO 13485 accredited by KAN may apply without an on-site audit
- Applications are processed only after payment of the PNBP fee
- A maximum of two corrective action opportunities is permitted
- If requirements are not met, the application must be resubmitted
Early preparation is essential to ensure a smooth and efficient certification process.
This is Where PT Multi Jasa Berjaya Comes In to Help
We understand that dealing with Ministry of Health regulations can be confusing.
That’s why, PT Multi Jasa Berjaya (MJB) is here to simplify the entire process — from preparation to certification issuance.
Here’s how we help you:
- Assessing your company’s readiness before the application process.
- Preparing SOPs and technical documents in accordance with Ministry of Health standards.
- Assisting the Technical Responsible Person (PJT) during training and audit processes.
- All the way through monitoring the audit results and ensuring your certificate is successfully issued.
Everything is handled quickly, neatly, and transparently.
Why Choose Us?
- Experienced in handling various types of medical device distribution companies
- Expert team with deep understanding of Kemenkes regulations and the OSS system
- Fast, transparent process in full compliance with regulations
We’re not just consultants — we’re your trusted partner in ensuring your business runs legally and confidently.
FAQ – Frequently Asked Questions
- Is CDB different from CDAKB?
No. CDB is the updated designation of CDAKB. The distribution quality standards remain the same, while the submission and evaluation mechanisms have been updated. - Can a company apply without an audit?
Yes, if the company holds an ISO 13485 certificate accredited by KAN. - Can PT Multi Jasa Berjaya assist with CDAKB SOP development?
Yes, we offer complete services including SOP drafting according to CDAKB standards and implementation guidance. - Is it mandatory for companies to have their own warehouse?
Ideally yes, but leased warehouses or third-party collaboration is acceptable as long as it meets medical device storage standards and is supported by official partnership documents. - Can the process be done without traveling to Jakarta?
Yes. Most of the process can be conducted online. However, a site audit by the Ministry of Health will still be carried out at your company’s distribution facility. - How do I start the process with PT Multi Jasa Berjaya?
You can contact us via WhatsApp or the contact form on our website. We'll schedule a consultation session to assess your company’s readiness and explain the entire process in detail. - How much is the service fee for CDAKB certification assistance?
Fees depend on your company’s condition and readiness. Please contact our team for the best offer and free consultation.
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