Median and typical-range figures computed from real BPOM approval data.
Data sourced from BPOM, updated daily.
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.
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. |
The Ministry of Health, through the Regalkes portal, not BPOM. Devices carry an AKD or AKL izin edar valid for up to five years.
AKD marks a domestically produced device; AKL marks an imported one.
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.