Indonesia Medical Device Regulation
Indonesia is Southeast Asia's largest healthcare market, with over 270 million people and a rapidly expanding medical technology sector. For medical device manufacturers seeking market access, Indonesia operates a dual-authority system: the Ministry of Health (Kemenkes) regulates medical devices and issues the mandatory marketing authorisation (NIE), while BPOM (the National Agency of Drug and Food Control) oversees pharmaceuticals, cosmetics, and shares responsibility for GMP inspections.
This site provides a practical English-language reference for foreign and domestic manufacturers navigating Indonesia's regulatory requirements.
What You Need to Know First
Foreign manufacturers cannot register directly with Kemenkes or BPOM. You must appoint an Indonesian legal entity as your Local Authorised Representative (LAR) — a company holding an IDAK (distribution licence) and CDAKB (Good Distribution Practice certificate). That entity becomes the holder of your product registration (NIE).
- Kemenkes (Ministry of Health) → medical device registration (NIE), Regalkes portal, market surveillance
- BPOM/NADFC → GMP inspections, pharmaceutical products, cosmetics, some overlap on device oversight
If you're registering a medical device, your primary regulator is Kemenkes, not BPOM.
Site Overview
| Section | What It Covers |
|---|---|
| Overview | Device definition, regulatory landscape, key legislation |
| Regulatory Authority | Kemenkes, BPOM/NADFC, Directorate of Medical Devices |
| Device Classification | Class A–D risk-based system, IVD classification |
| Market Access — NIE | NIE registration, IDAK, CDAKB, pathways, timelines |
| Local Representation | LAR, PT PMA, neutral licence holder, LoA |
| Regalkes Portal | Online registration system, submission steps |
| Technical Dossier | ASEAN CSDT, administrative and technical documents |
| Labeling | Bahasa Indonesia rules, Halal labeling, e-labeling |
| Post-Market Surveillance | Adverse events, NIE renewal, change notifications |
| Special Access | Emergency use, compassionate use, research imports |
| Digital Health & SaMD | Software as a Medical Device, connected devices |
| ASEAN Harmonisation | AMDD, CSDT alignment, mutual recognition |
| Resources | Glossary, key regulations, useful links |
Key Facts at a Glance
| Item | Detail |
|---|---|
| Primary regulator | Kemenkes (Ministry of Health) |
| Secondary regulator | BPOM / NADFC |
| Registration number | NIE — Nomor Izin Edar |
| NIE validity | 5 years (renewable) |
| Registration system | Regalkes portal (regalkes.kemkes.go.id) |
| Classification system | Class A (lowest) to Class D (highest) |
| Framework alignment | ASEAN AMDD / GHTF |
| Dossier format | ASEAN CSDT |
| Key legislation | Permenkes No. 62/2017 |
| Foreign manufacturer | Must appoint local LAR (IDAK + CDAKB holder) |
| Language requirement | Bahasa Indonesia mandatory for all safety information |
Quick Navigation by Role
If you are a foreign manufacturer: Start with Local Representation → then Market Access — NIE → then Technical Dossier.
If you are an Indonesian distributor or LAR: Start with Market Access — NIE → Regalkes Portal → Post-Market Surveillance.
If you are classifying a device: Start with Device Classification.
This site is a reference guide for educational purposes only. It does not constitute legal or regulatory advice. Regulations change frequently — always verify requirements with Kemenkes, BPOM, or a qualified Indonesian regulatory affairs professional before making compliance decisions.