BPOM registration timeline · Medical devices

How long does medical devices registration take in Indonesia?

Median and typical-range figures computed from real BPOM approval data.

Produced locally

BPOM doesn’t publicly record submission dates for this category, so a reliable estimate isn’t available here. Contact us for a timeline based on our casework.

Imported

BPOM doesn’t publicly record submission dates for this category, so a reliable estimate isn’t available here. Contact us for a timeline based on our casework.

Data sourced from BPOM, updated daily.

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

Obtain the company-level IDAK license
The distribution license (formerly IPAK) must exist before any device can be registered.
Secure the CDAKB certificate
Good distribution practice certification, mandatory since July 2024.
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.
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.

Prefix	Product type	What it means
NA, NB, NC, ND, NE	Cosmetic	Notification. The second letter is the region of manufacture: A Asia (incl. Indonesia), B Australia, C Europe, D Africa, E the Americas.
NK	Cosmetic	Older cosmetic registration scheme.
MD	Processed food	Produced in Indonesia (dalam negeri).
ML	Processed food	Imported (luar negeri).
SD, SI	Health supplement	SD produced domestically, SI imported.
TR, TI	Traditional medicine	Jamu and herbal products. TR domestic, TI imported.
DK, DBL, DTL, GKL	Pharmaceutical drug	Marketing authorization (izin edar / NIE). The class letters mark over-the-counter, limited, or prescription status.
AKD, AKL	Medical device	Registered with the Ministry of Health, not BPOM. AKD domestic, AKL imported.
PKD, PKL	Household (PKRT)	Household and personal-care products, regulated by the Ministry of Health. PKD domestic, PKL imported.

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.