CDAKB: Indonesia Good Distribution Practice for Medical Devices Explained

1. Key takeaways

CDAKB (Cara Distribusi Alat Kesehatan yang Baik, the Good Distribution Practice for medical devices) is the Indonesian quality management standard for device distribution. Its legal basis is Permenkes No. 4/2014, and it has evolved from a voluntary benchmark into a hard gate controlling registration submissions, e-Katalog listing and even the practical operability of an NIB. Any manufacturer appointing a local partner, or building its own distribution entity, should treat CDAKB status as a first-order due diligence item rather than a paperwork detail, because the consequences of missing certification now propagate through every downstream channel, from new registrations to public tenders and the OSS licensing system itself.

• Article 2 paragraph (1) of Permenkes No. 4/2014 requires every device distributor, and each of its branches, to implement CDAKB in its distribution activities.
• The standard covers six areas: a documented, structured and continuously executed quality management system; personnel management including competence and training records; compliant facilities and infrastructure, especially warehousing conditions; procurement, storage and distribution across the full chain; traceability that supports anti-counterfeiting and recalls; and control of outsourced activities.
• From 1 July 2024, a CDAKB certificate became a prerequisite for submitting medical device marketing authorisation applications.
• From 1 January 2025, it is also a mandatory condition for product listing on e-Katalog V6.
• Permenkes No. 11/2025 has embedded CDAKB compliance into the OSS system: without a valid CDAKB certificate, the NIB under KBLI 46691, now 46791, cannot actually operate.

2. Legal basis

The foundation is Permenkes No. 4/2014. Its Article 2 paragraph (1) states that every medical device distributor, and every branch of such a distributor, must implement CDAKB when carrying out distribution activities. The transition to mandatory status was driven by the circular of the Directorate General of Drugs and Medical Devices FR.03.01/E/884/2024, which made the CDAKB certificate a precondition for marketing authorisation submissions, with a socialisation period running from 1 May 2024 to 30 June 2024 before enforcement from 1 July 2024. Since 1 January 2025, the certificate has additionally been required for e-Katalog V6 product listing.

The position after Permenkes No. 5/2026 is important to understand. Permenkes 5/2026 repealed the great majority of the provisions of Permenkes 4/2014, but expressly retained Article 2 and its annex, so the substantive CDAKB obligation remains in force. At the same time, Permenkes No. 11/2025 has embedded CDAKB compliance into the OSS system, which means that a company holding an NIB under KBLI 46691, now recoded as 46791, cannot actually operate the licence without a valid CDAKB certificate. The regulatory direction is unambiguous: distribution quality management is no longer advisory but enforceable through the licensing system itself.

3. Expert insights

The consequences of holding no CDAKB are asymmetric, and understanding this asymmetry matters for planning. Products already registered will not be revoked, but the company cannot register new products and cannot participate in government tenders. Because the certificate must be uploaded at every registration and at every bid, CDAKB operates as a growth switch rather than a stock switch. The distinction is critical: legacy products can continue to sell, but the enterprise immediately loses the ability to expand its portfolio or compete for public procurement, which in the Indonesian device market is where volume concentrates. For a manufacturer choosing a partner, a partner without valid CDAKB is therefore not merely a weaker distributor but one that will fail at the first new registration or tender.

For partner selection, this asymmetry translates into a concrete checklist. The CDAKB certificate scan, its validity period and its certification scope are mandatory review items, and one point is frequently missed: Article 2 paragraph (1) explicitly covers branches, so each branch engaged in distribution should hold its own certification. A headquarters-only certificate with uncertified branches will create problems in cross-regional distribution, often surfacing only after goods are in motion and the commercial relationship is already committed. Timeline planning also matters: because the socialisation window before enforcement ran from 1 May 2024 to 30 June 2024, older partners may hold certificates issued under different expectations, and the certification scope should be read against the products actually intended for distribution rather than assumed to be comprehensive.

4. Practical recommendations

• Collect the CDAKB certificate scan, check the expiry date and confirm the certification scope before appointing any licence holder or importer.
• Verify whether each branch that will handle distribution holds its own CDAKB certificate, since the obligation in Article 2 paragraph (1) applies to branches individually.
• Confirm that the certificate will remain valid across your registration and tender calendar, because uploads are required at each submission.
• Where a partner relies on legacy IPAK-era arrangements, check that its CDAKB status and OSS data are aligned after the Permenkes No. 11/2025 integration.
• For your own entity, plan the CDAKB build, including documented quality management, training records, warehousing conditions and traceability, as a prerequisite project before any new registration submission.
• Treat the retained Article 2 and annex of Permenkes 4/2014, notwithstanding the repeal of most of that regulation by Permenkes 5/2026, as the continuing source of the obligation.
• Document the six coverage areas of the standard during partner audits, since traceability and control of outsourced activities are the areas most often weak in practice.

5. Verification checklist

• □ Confirm Article 2 paragraph (1) of Permenkes No. 4/2014 as the continuing obligation, including coverage of branches.
• □ Confirm the circular FR.03.01/E/884/2024 making the CDAKB certificate a prerequisite for marketing authorisation, with the socialisation window from 1 May 2024 to 30 June 2024.
• □ Confirm Permenkes No. 11/2025 embedding CDAKB into OSS, with the NIB under KBLI 46691, now 46791, unable to operate without the certificate.
• □ Confirm Permenkes No. 5/2026 repealing most of Permenkes 4/2014 while retaining Article 2 and its annex.
• □ Confirm the e-Katalog V6 listing requirement effective from 1 January 2025.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com