BPOM manages medical device registration for the fourth most populous country in the world. Our database indexes their full registration dataset — 180,000+ records, searchable by manufacturer, product type, or registration number.
Search Indonesia registrations →Indonesia runs one of the larger medical device registration systems in Southeast Asia. BPOM — Badan Pengawas Obat dan Makanan — is the national food and drug authority responsible for regulating medical devices alongside pharmaceuticals and cosmetics. If you're trying to figure out what devices are registered in Indonesia, which manufacturers are active in the market, or what the competitive landscape looks like in a specific product category, the BPOM registry is the authoritative source.
The official portal exists and is technically accessible. The search functionality is limited and was built for regulators, not researchers. If you're looking for bulk data or cross-market comparison, using the BPOM portal directly means a lot of manual work. Meridian Trace indexes the same underlying data in a normalized, searchable format alongside our other seven Asian markets.
BPOM classifies medical devices into four classes based on risk level:
| Class | Risk Level | Examples | Review Timeline* |
|---|---|---|---|
| Class A | Low | Bandages, tongue depressors, examination gloves | 45 working days |
| Class B | Medium-low | Syringes, blood pressure monitors, surgical drapes | 60 working days |
| Class C | Medium-high | Infusion pumps, powered surgical instruments, CGM systems | 90 working days |
| Class D | High | Implantable devices, heart valves, neurostimulators | 90 working days |
* Official timelines. Real-world review periods often run longer, particularly for Class C and D devices. Talk to your local regulatory consultant for realistic expectations.
Unlike some markets, Indonesia does not allow foreign manufacturers to hold BPOM registrations directly. All medical device registrations must be held by a local Indonesian importer or distributor — the company authorized to import and market the device in Indonesia.
This has a few practical implications. First, when you search BPOM data, the "manufacturer" field sometimes shows the local importer rather than the OEM. A Medtronic device registered by PT Medtronic Indonesia will appear under that name. We try to surface the underlying OEM where we can infer it, and we tag this clearly in the data so you know it's an inference rather than a scraped fact.
Second — and this is relevant for distributor relationships — registrations in BPOM are tied to the local license holder. If you change distributors, the existing registration stays with the previous one. You typically need to either transfer the registration or file new registrations with the new importer. This has contract implications that should be addressed before signing any distribution agreement. See our guide on distributor vetting for more on this.
BPOM registration numbers follow the format AKL-[sequence] for medical devices (versus AKD for diagnostics, AKR for in vitro reagents). The number is unique per product per license holder — meaning the same physical device registered by two different importers will have two different AKL numbers. This is worth knowing when you're comparing competitor registrations across distributors.
Our Indonesia data includes active registrations, lapsed registrations, and where we've been able to infer them, OEM relationships behind local license holders. You can search by:
Results can be filtered and exported to CSV on Professional tier accounts.
50 free searches per month. No account setup required beyond email.
No government portal. No login forms in Bahasa Indonesia. 50 free searches, results in seconds.