BPOM / NADFC — National Agency of Drug and Food Control
What Is BPOM?
Badan Pengawas Obat dan Makanan (BPOM), known internationally as the National Agency of Drug and Food Control (NADFC), is Indonesia's equivalent of the US FDA — but with a broader mandate covering food, pharmaceuticals, traditional medicines, cosmetics, and health supplements, in addition to some medical device oversight functions.
BPOM operates as an independent government agency directly accountable to the President. It is headquartered in Jakarta and has regional offices (Balai Besar/Balai POM) across Indonesia's provinces.
BPOM vs Kemenkes: What Each Regulates
This distinction is critical for medical device manufacturers:
| Product / Activity | Regulated By |
|---|---|
| Medical device NIE registration | Kemenkes |
| Medical device distribution licence (IDAK) | Kemenkes (via OSS) |
| Pharmaceutical drugs | BPOM |
| Traditional medicines (jamu, herbal) | BPOM |
| Cosmetics | BPOM |
| Food and health supplements | BPOM |
| GMP inspection of device manufacturers | BPOM (with Kemenkes coordination) |
| Clinical trial authorisation for devices | BPOM |
| Drug-device combination products | Both (case-by-case) |
If you are registering a medical device, your primary regulatory pathway is through Kemenkes, not BPOM. You do not submit device registration dossiers to BPOM. However, BPOM becomes relevant if your device requires GMP inspection of the manufacturing facility or if you are conducting clinical investigations.
BPOM's Role in Medical Device Regulation
1. GMP Inspections of Manufacturers
BPOM has authority to conduct Good Manufacturing Practice (GMP) inspections of medical device manufacturing facilities — both domestic and, in some cases, overseas facilities. Inspections may be:
- Pre-notified — scheduled in advance
- Unannounced — without prior notification, typically triggered by compliance history or recall events
Risk-based inspection frequency: higher-risk devices (Class C and D) are subject to more frequent and intensive inspections.
2. Clinical Trial Authorisation
Any clinical investigation involving an unregistered medical device in Indonesia requires prior approval from BPOM (in addition to ethics committee clearance). See the Import for Research page for details.
3. Drug-Device Combinations
For devices that incorporate a pharmaceutical substance as an integral component, BPOM may be involved alongside Kemenkes in determining the primary regulatory pathway and applicable requirements.
4. Market Surveillance (Complementary)
BPOM conducts market surveillance on products within its mandate. For devices, this overlaps with Kemenkes's own market sampling activities.
BPOM Official Resources
- BPOM website: www.pom.go.id
- e-Registration portal: e-reg.pom.go.id (for pharmaceutical products)
- BPOM publishes regulatory guidance, public alerts, and recall notices on its official website and social media channels