CDAKB Is Now CDB: What Medical Device Distributors in Indonesia Need to Know About Permenkes No. 11/2025

If you distribute medical devices in Indonesia, or you’re planning to, there’s a naming change worth knowing about. Under Permenkes No. 11 of 2025 on Business Activity and Product/Service Standards for Risk-Based Business Licensing in the Health Subsector, the certification previously known as CDAKB (Cara Distribusi Alat Kesehatan yang Baik) has been consolidated and renamed CDB (Cara Distribusi yang Baik) for medical devices.

This isn’t just a label swap. The regulation restructures the entire standard, from certification requirements to verification timelines, into Indonesia’s broader risk-based business licensing framework. This article breaks down what changed, what stayed the same, and what medical device distributors need to do next.

1. Introduction

Indonesia’s Ministry of Health signed Permenkes No. 11/2025 in Jakarta on October 3, 2025, under Minister Budi G. Sadikin. The regulation implements Article 5(7), Article 296, and Article 457 of Government Regulation No. 28 of 2025 on Risk-Based Business Licensing, consolidating business activity and product/service standards across the entire health subsector, including pharmaceuticals, medical devices, household health supplies (PKRT), and more, into a single, unified framework.

For medical device distributors specifically, this means the certification standard governing good distribution practices has been reissued under a new structure and a new name.

2. What Changed: CDAKB Is Now CDB

Under the previous framework, Permenkes No. 14/2021 (as amended), the good distribution practice certification for medical devices was called CDAKB, Cara Distribusi Alat Kesehatan yang Baik. Permenkes No. 11/2025 replaces that term entirely with CDB, Cara Distribusi yang Baik untuk Alat Kesehatan.

The underlying concept remains largely the same: a certification confirming that a distributor has implemented proper quality control throughout the distribution chain to protect the safety, quality, and benefit of medical devices. What’s changed is the terminology, the regulatory home (now unified under Permenkes 11/2025’s broader health-subsector licensing framework), and several procedural details covered below.

3. Legal Basis

Permenkes No. 11/2025 sits within Indonesia’s broader risk-based licensing reform, and formally revokes the prior regulations governing health-sector business standards.

4. What CDB Actually Covers

Under Permenkes 11/2025, CDB for Medical Devices is defined as the guidance used throughout distribution and quality control activities, intended to ensure that distributed medical devices maintain their safety, quality, and benefit across the entire distribution chain.

A CDB Certificate, correspondingly, is issued to a Medical Device Distributor or Medical Device Distributor Branch that has implemented every aspect of CDB for Medical Devices.

5. Who Needs a CDB Certificate

The regulation applies to businesses operating under KBLI 46691 (Wholesale Trade of Laboratory Equipment, Pharmaceutical Equipment, and Medical Equipment for Humans), split into two business classifications.

• Medical Device Distributor (Distributor Alat Kesehatan) — a facility conducting wholesale trade to distribute medical devices, structured as a limited liability company (PT) or cooperative
• Medical Device Distributor Branch (Cabang Distributor Alat Kesehatan) — a business unit of a Medical Device Distributor conducting the same wholesale distribution activities at a separate location

6. Requirements for CDB Certification

Before applying for a CDB Certificate, a business first needs its underlying Business License (PB) as a Medical Device Distributor. Once that’s in place, CDB certification requires meeting several general conditions.

• Technical Person in Charge (PJT) — a dedicated, full-time staff member who has completed CDB training for Medical Devices, holding at least a Diploma III in a health, engineering, or science-related field
• Facilities and infrastructure — physical premises appropriate to the medical device categories distributed, meeting Ministry-established CDB guidelines
• Self-assessment — an internal review of quality documentation and evidence of quality system implementation aligned with CDB standards
• State revenue payment (PNBP) — payment of the applicable non-tax state revenue fee

Facilities need to include, at minimum, an administrative area, receiving area, shipping area, quarantine area, and storage area, along with equipment such as fire extinguishers (APAR), pest control measures, a thermohygrometer, and racks or pallets appropriate to the products handled.

7. Documents You’ll Need to Submit

Applications are submitted through Indonesia’s OSS (Online Single Submission) system, with several categories of supporting documentation.

• Applicant data — the Medical Device Distributor Business License (under KBLI 46691), a formal application letter on company letterhead naming the Technical Person in Charge, and the PJT’s CDB training certificate
• Facility documentation — room layout plans, the product handling flow, and a list of operational warehouse equipment matching the medical device categories distributed
• Product category documentation — a list of the medical device categories and specific products to be distributed
• Self-assessment documentation — results of the internal quality system review and evidence of CDB implementation
• Proof of PNBP payment

8. Verification Process and Timeline

The Ministry of Health conducts conformity assessment for CDB Certificates, following a defined process and timeline.

• 1Document Verification: Conducted through the OSS system.
• 2Field Verification: Carried out through physical or virtual site visits, where required.
• 3Processing Time: The CDB Certificate is issued within a maximum of 30 days from a complete application.
• 4Correction Window: Businesses without ISO 13485 certification covering medical device distribution may need to complete both document and field verification, with up to two correction rounds allowed (10 days each for document corrections, 30 days each for field-related CAPA submissions).
• 5Streamlined Path: Non-License Holders or License Holders who already hold ISO 13485 certification covering medical device distribution go through document verification only, simplifying the process.

9. Ongoing Obligations for Certificate Holders

Once issued, a CDB Certificate comes with continuing compliance obligations, not a one-time approval.

• Annual internal audit reporting — submitted to the Ministry of Health every year
• Activation deadlines — distributors must begin procurement and distribution activities matching their certified product categories within 12 months of first issuance, or 6 months following a certificate renewal
• Voluntary revocation — businesses that stop operating in medical device distribution must formally apply to revoke their CDB Certificate
• Renewal timing — renewal applications must be submitted at least 6 months before the current certificate expires

10. What Happens to Existing CDAKB Certificates

Businesses already holding valid licenses or certificates issued under the previous CDAKB framework don’t need to restart from scratch. Under the regulation’s transitional provisions, business licenses issued before Indonesia’s risk-based OSS system took effect remain valid and get updated according to current requirements, while applications already in process continue under the previous Permenkes 14/2021 framework until the updated OSS system is ready to process them under the new rules.

11. What This Means for Medical Device Distributors

For foreign medical device manufacturers and their Indonesian distribution partners, this regulatory update carries a few practical implications worth acting on.

• Update your terminology across contracts and SOPs — references to “CDAKB” should be revised to “CDB for Medical Devices” to stay aligned with current regulatory language
• Confirm your PJT’s training is current — CDB training specifically, not the older CDAKB curriculum, is now the reference standard
• Check whether ISO 13485 status affects your verification path — holding valid ISO 13485 certification covering medical device distribution can meaningfully simplify your CDB verification process
• Plan branch expansion carefully — Medical Device Distributor Branches face their own certification requirements and are limited to distributing within their home province, unless formally authorized to serve a neighboring one
• Build activation deadlines into your launch timeline — the 12-month (or 6-month, for renewals) activation requirement means certification needs to align closely with your actual commercial launch plan

12. Conclusion

The shift from CDAKB to CDB under Permenkes No. 11/2025 reflects more than a naming update. It folds medical device distribution standards into Indonesia’s unified, risk-based health-subsector licensing framework, with clearer documentation requirements, defined verification timelines, and continuing compliance obligations for certificate holders.

For medical device distributors, whether already operating in Indonesia or planning to enter, the practical priority is straightforward: align your terminology, documentation, and PJT training with the current CDB standard, and build certification timing into your broader market entry or renewal planning.

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