Skip to content
Talk to our team
Indonesia market landscape · Medical devices

Medical device market and registration in Indonesia

Medical device (AKD/AKL) records are managed by the Ministry of Health and are not currently included in the BPOM database sync. The category overview below applies regardless.

How long does medical devices registration take? →

Regulator
Indonesia’s Ministry of Health (via the Regalkes portal)
Type
Product registration (NIE / izin edar)
Codes
AKD, AKL
Validity
Up to 5 years

Medical devices and in-vitro diagnostics are registered with the Ministry of Health through the Regalkes portal, not BPOM, even though they are often grouped under the BPOM label. A domestically produced device carries an AKD number and an imported one carries an AKL number. The registration is valid for up to five years.

Devices fall into four ASEAN risk classes, A through D, which set the documentation, fees and review depth. Before any product registration, the company needs an IDAK distribution license, and a CDAKB good-distribution certificate has been mandatory since July 2024. This category is governed by Health Minister Regulation (PMK) 62 of 2017.

How registration works

  1. Obtain the company-level IDAK license
    The distribution license (formerly IPAK) must exist before any device can be registered.
  2. Secure the CDAKB certificate
    Good distribution practice certification, mandatory since July 2024.
  3. Classify the device and build the CSDT dossier
    Assign the ASEAN class (A to D) and compile the Common Submission Dossier Template, with ISO 13485 and a Free Sale Certificate for imported devices.
  4. Submit via Regalkes and receive the NIE
    The izin edar (AKD or AKL) is valid for up to five years.

What you need

  • An IDAK distribution license at company level before any product registration.
  • A CDAKB good-distribution certificate (mandatory since July 2024).
  • For imported devices, ISO 13485 and a Certificate of Free Sale; for domestic devices, a local manufacturing certificate (CPAKB).
  • Halal certification phases in by class, starting with Class A on 17 October 2026.

Reading a BPOM number

The prefix on a registration number tells you the product type and, for many categories, whether it was made in Indonesia or imported.

PrefixProduct typeWhat it means
NA, NB, NC, ND, NECosmeticNotification. The second letter is the region of manufacture: A Asia (incl. Indonesia), B Australia, C Europe, D Africa, E the Americas.
NKCosmeticOlder cosmetic registration scheme.
MDProcessed foodProduced in Indonesia (dalam negeri).
MLProcessed foodImported (luar negeri).
SD, SIHealth supplementSD produced domestically, SI imported.
TR, TITraditional medicineJamu and herbal products. TR domestic, TI imported.
DK, DBL, DTL, GKLPharmaceutical drugMarketing authorization (izin edar / NIE). The class letters mark over-the-counter, limited, or prescription status.
AKD, AKLMedical deviceRegistered with the Ministry of Health, not BPOM. AKD domestic, AKL imported.
PKD, PKLHousehold (PKRT)Household and personal-care products, regulated by the Ministry of Health. PKD domestic, PKL imported.
Registering medical devices and IVDs in Indonesia? Talk to our Indonesia team.

Frequently asked questions

Who regulates medical devices in Indonesia?

The Ministry of Health, through the Regalkes portal, not BPOM. Devices carry an AKD or AKL izin edar valid for up to five years.

What is the difference between AKD and AKL?

AKD marks a domestically produced device; AKL marks an imported one.

What do I need before registering a device?

A company-level IDAK distribution license and a CDAKB good-distribution certificate, which has been mandatory since July 2024.

Data sourced from BPOM, updated daily. medical device registration with Emerhub.