IDAK Explained: Indonesia Medical Device Distribution Licence Requirements and Fees

1. Key takeaways

IDAK (Izin Distribusi Alat Kesehatan, the medical device distribution licence) is the company-level licence that allows an Indonesian entity to legally purchase, store, distribute and supply medical devices. It replaced the former IPAK (Izin Penyalur Alat Kesehatan). For any foreign manufacturer entering Indonesia, understanding IDAK is the first step in evaluating a local partner, because the licence determines whether the holder is legally able to trade in devices at all.

• IDAK is the successor to IPAK; the former legal basis Permenkes 1191/2010 has been repealed, and the licence now rests on PP No. 5/2021 and Permenkes No. 14/2021.
• IDAK is valid for 5 years and must be renewed upon expiry; the old IPAK had no clearly defined validity period.
• All applications are processed online through OSS-RBA, replacing the offline and manual procedures of the IPAK era.
• A valid CDAKB certificate is a mandatory prerequisite for IDAK, a requirement that did not exist under IPAK.
• The licence requires a designated PJT (Penanggung Jawab Teknis, technical person in charge), and since October 2024 the cooperation agreement between the company and the PJT must be executed as a notarial deed.
• Submission runs through OSS with single sign-on integration to the Kemenkes system.
• The PNBP for IDAK is approximately IDR 1,000,000 (an industry reference value of roughly USD 60-70), which excludes premises, personnel and CDAKB certification costs.

2. Legal basis

The governing instruments are PP No. 5/2021 on risk-based business licensing and Permenkes No. 14/2021 on business activity standards and product standards in the health sector under risk-based licensing. The prior basis for IPAK, Permenkes 1191/2010, has been repealed. Kemenkes announcement FR.03.06/E.V/0373/2024 dated 23 January 2024 governs the conversion of existing IPAK licences into IDAK. Four hard conditions apply to applicants: first, a legally established Indonesian legal entity (a PT or a cooperative) whose articles of association cover device activities in the scope of business; second, an NIB (business identification number) with the business classification code for device wholesale, KBLI 46691; third, physical business premises, comprising an office and a warehouse that meet distribution standards, with virtual offices not accepted and the licence tied to the registered address so that relocation requires a variation; and fourth, a PJT with a relevant educational background in pharmacy, electro-medical engineering, medical laboratory technology or public health, who must be registered in the Kemenkes information system.

KBLI coding matters and has recently changed. KBLI 2025 has moved the wholesale of medical and laboratory devices for human use from KBLI 46691 to KBLI 46791, with the switchover in the OSS system taking full effect from 16 June 2026. Retail corresponds to 47725, and device manufacturing is distributed across codes such as 32501, 32502 and 32509. Companies already registered in OSS must verify and complete the code update; failing to do so may trigger system warnings or even audit risk. The OSS catalogue current at the time should always be taken as authoritative.

3. Expert insights

On cost, the PNBP for an IDAK is approximately IDR 1,000,000 (an industry reference value, roughly USD 60-70). This figure excludes the wider compliance investment: premises, personnel and CDAKB certification all sit outside the official fee. Budgeting only the PNBP therefore understates the true cost of becoming a licensed distributor by a wide margin, and counterparties quoting a licence package should be asked to itemise these components. No amounts beyond this reference value should be assumed, since actual invoicing takes place through the official systems.

The deeper point is that IDAK functions as the switch that determines whether a company can hold a licence at all, and it is the item most easily overlooked in due diligence. When verifying a prospective partner, review not only the certificate itself but three specific attributes: the validity period, whether the registered address matches the actual place of business, and whether the PJT is on record in the Kemenkes system. If any one of the three does not match, the application may be blocked by the system at the moment of actual submission, which is precisely when the delay is most costly for a launch timeline.

4. Practical recommendations

• Before signing any distribution or appointing agreement, obtain a copy of the partner’s IDAK and check the expiry date against your intended launch and supply schedule.
• Confirm that the registered address on the licence matches the physical office and warehouse where goods will actually be stored; a mismatch is grounds for the system to refuse subsequent submissions.
• Verify that the PJT named by the partner is registered in the Kemenkes information system and that the cooperation agreement exists as a notarial deed, consistent with the requirement effective since October 2024.
• Ask which KBLI code the partner holds. Companies still on 46691 must transition to 46791 in OSS by 16 June 2026; an un-migrated code is an early warning sign.
• Budget the PNBP of approximately IDR 1,000,000 separately from premises, staffing and CDAKB certification costs, and treat the fee as a reference value pending confirmation at invoicing.
• If you are considering obtaining IDAK for your own entity rather than relying on a partner, sequence the four conditions deliberately: entity, NIB, premises and PJT, since CDAKB certification must precede or accompany the licence application.

5. Verification checklist

• □ Confirm the governing instruments: PP No. 5/2021 and Permenkes No. 14/2021, with Permenkes 1191/2010 repealed.
• □ Confirm Kemenkes announcement FR.03.06/E.V/0373/2024 dated 23 January 2024 on IPAK to IDAK conversion.
• □ Confirm the KBLI 2025 recoding from 46691 to 46791, with the OSS switchover on 16 June 2026, and retail code 47725 and manufacturing codes 32501, 32502, 32509 as applicable.
• □ Confirm the IDAK PNBP of approximately IDR 1,000,000 as an industry reference value, and treat premises, personnel and CDAKB certification as separate cost lines.
• □ Confirm the PJT notarial deed requirement effective from October 2024 and the single sign-on path through OSS to the Kemenkes system.

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