Indonesia Medical Device Registration (KEMENKES / MoH RI)
1. Regulatory Authority & Framework
Indonesia regulates medical devices under:
- Regulation of the Ministry of Health (MoH)
- Permenkes 62/2017 (medical device distribution & licensing)
- Permenkes 14/2021 (risk classification)
- Regulation 16/2020 (electronic medical device systems)
Oversight bodies:
- KEMENKES – Indonesia Ministry of Health
- Ditjen Farmalkes – Directorate General of Pharmaceutical & Medical Devices
- Digital platforms:
- OSS-RBA – business licensing
- e-Regalkes – medical device registration portal
2. Device Classification (Class A/B/C/D)
Indonesia follows a GHTF / ASEAN-aligned system:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low | Non-sterile bandages, basic tools |
| Class B | Low–Moderate | Infusion sets, suction pumps |
| Class C | Moderate–High | Blood glucose meters, HF surgical devices |
| Class D | High | Ventilators, implants, surgical robots |
Note: IVDs also follow risk classification A–D.
3. Registration Routes & Requirements
All foreign devices must obtain:
- Local Authorized Representative (LAR)
- MoH Distribution License
- Product Registration Number (AKL / AKD)
Registration types:
- AKL → Imported medical devices
- AKD → Locally manufactured devices
- PKRT → Household/consumer medical supplies (separate route)
4. Local Authorized Representative (LAR / License Holder)
Foreign manufacturers must appoint an Indonesian company with:
- IDAK license (Medical Device Distributor License)
- NIB (Business Identification Number) via OSS-RBA
- Responsibilities include:
- Product registration
- Import permit & customs
- Post-market surveillance
- AE reporting & recalls
- Ensure Bahasa Indonesia labeling compliance
One LAR = one registration.
Multiple LARs allowed, but each needs separate AKL numbers.
5. Dossier Requirements (Indonesia CSDT-aligned)
Submission is done via e-Regalkes. Required documentation includes:
Administrative Documents
- Power of Attorney
- Letter of Authorization (LOA)
- Free Sale Certificate / Market Authorization from reference countries
- ISO 13485 of manufacturer
- Manufacturer license
- Product confirmation letter
- Declaration of Conformity
Technical Documents (CSDT Format)
- Device description & intended use
- Design verification & validation data
- Biocompatibility data
- Electrical safety (IEC 60601 series)
- Software documentation (IEC 62304)
- Cybersecurity (if software-driven)
- Sterilization validation
- Risk management (ISO 14971)
- Clinical evaluation (CER)
- Labeling & IFU (Bahasa Indonesia)
- PMS plan
6. Fees & Timelines (Typical)
Official MoH Fees
- Class A: ~IDR 1–3 million
- Class B: ~IDR 3–5 million
- Class C: ~IDR 5–7 million
- Class D: ~IDR 7–10 million
Review Timelines (Typical)
- Class A: 1–3 months
- Class B: 3–6 months
- Class C/D: 6–9+ months
Timelines depend heavily on dossier quality & MoH queue.
Fast-track possible for products approved in reference countries (US/EU/CA/AU/MY/SG/etc.).
7. Labeling & IFU Requirements
Labeling must be compliant with Indonesian rules:
- Device name/model
- Manufacturer & LAR details
- Country of origin
- Lot / serial number
- Manufacturing/expiry date
- Storage & handling instructions
- Bahasa Indonesia mandatory
- IFU in Bahasa Indonesia (local translation can be provided on sticker or booklet)
8. Importation Requirements
Steps for importing:
- NIB + IDAK license
- MoH Registration Number (AKL)
- Customs clearance
- Import report via e-LKPP (if applicable)
High-risk devices (Class C/D) may require testing certificates at customs or additional declarations.
9. Post-Market Obligations
Indonesia has strict PMS responsibilities:
- Adverse event reporting
- Field safety corrective actions (FSCA)
- Product recall procedures
- Distribution record-keeping
- Annual device availability reporting
10. Notes for Your Device Portfolio (Consulting View)
| Device Type | Expected Class | Indonesia Requirements |
|---|---|---|
| Soft contact lenses | Class C | Requires biocompatibility, clinical evaluation, CE/FDA speeds pathway |
| Surgical robots / AR/MR platforms (SyngAR™) | Class D | Full dossier + cybersecurity + software safety + IEC 60601 electrical safety |
| High-frequency electrosurgical devices | Class C/D | EMC + electrical safety critical; CER required |
| Blood glucose meters & strips | Class C | ISO 15197 validation required; local lab testing rarely required |
| Serum preparation device (single-use) | Class B/C | Sterilization validation + performance data |
11. Key Advantages of Indonesia Market
- Population: 275+ million, largest ASEAN market
- High reliance on imported medical devices (>90%)
- ASEAN CSDT alignment → easier harmonization with MY, SG, VN, TH
- CE/FDA products typically receive smoother review