Related Guide
Documents Required for Medical Device Registration in Indonesia
Full document checklist based on the official Pedoman Pelayanan Izin Edar Alat Kesehatan (Guidelines for Medical Devices Marketing Authorization Services) issued by the Ministry of Health of the Republic of Indonesia.
→ Read the Full Registration Guide
How to use this checklist: Documents are organized by submission form as required in the online e-registration system (regalkes.kemkes.go.id). Requirements are drawn directly from the Ministry of Health’s official marketing authorization guideline. Always verify current requirements with a qualified regulatory consultant before submission, as regulations may be updated.
Types of marketing authorization applications
Type 4
Renewal + Variation
New application — document checklist
The new marketing authorization application comprises six forms submitted through the online system. Requirements per form are outlined below, organized by device class (A/B/C/D).
Form A
Administration Data
| Document |
A |
B |
C |
D |
Applies to |
| Production Certificate of medical device issued by the Minister of Health (for local product only) |
✓ |
✓ |
✓ |
✓ |
Local (AKD) only |
| Medical Device Distributor License / IPAK issued by the Minister of Health |
✓ |
✓ |
✓ |
✓ |
Local & import |
| Power of Attorney (LoA) as sole agent or sole distributor — notarized for local, legalized by Indonesian Embassy (KBRI) for imported |
✓ |
✓ |
✓ |
✓ |
Local & import |
| Certificate of Free Sale (CFS) from the competent authority in the country of origin |
✓ |
✓ |
✓ |
✓ |
Import (AKL) only |
| Certification confirming conformity to product standards, safety, efficacy, and quality system (ISO 9001, ISO 13485, CE Certificate) |
✓ |
✓ |
✓ |
✓ |
Local & import |
| Executive Summary — marketing history, mechanism of action, intended use, formula, and product usage history |
— |
— |
✓ |
✓ |
Class C & D only |
| Declaration of conformity to applicable standards in design and manufacturing |
✓ |
✓ |
✓ |
✓ |
Local & import |
| Patent / brand name certificate or declaration of no objection to release the brand name / agency |
✓ |
✓ |
✓ |
✓ |
Local & import |
| Statement letter declaring that all uploaded documents are original and accurate |
✓ |
✓ |
✓ |
✓ |
Local & import |
Form B
Product Information
| Item required |
A |
B |
C |
D |
| Explanation / description of the medical device | ✓ | ✓ | ✓ | ✓ |
| Description and features of the medical device | ✓ | ✓ | ✓ | ✓ |
| Purpose of use / intended use | ✓ | ✓ | ✓ | ✓ |
| Indication | ✓ | ✓ | ✓ | ✓ |
| Instructions for Use (IFU) | ✓ | ✓ | ✓ | ✓ |
| Contra-indication, warning, caution, side effects (if any) | ✓ | ✓ | ✓ | ✓ |
| Material composition | ✓ | ✓ | ✓ | ✓ |
| Manufacturer information | ✓ | ✓ | ✓ | ✓ |
| Production process description | ✓ | ✓ | ✓ | ✓ |
Form C
Specification & Quality Assurance Information
| Item required |
A |
B |
C |
D |
| Functional characteristics and technical performance specifications | ✓ | ✓ | ✓ | ✓ |
| Summary of design verification and validation documents | ✓ | ✓ | ✓ | ✓ |
| Software validation test results (if applicable) | ✓ | ✓ | ✓ | ✓ |
| Research results for devices containing biological material | ✓ | ✓ | ✓ | ✓ |
| Analysis and/or clinical test results (specificity, sensitivity, stability) — for reagents or IVD products | ✓ | ✓ | ✓ | ✓ |
| Analysis test result / clinical test result and device safety data | ✓ | ✓ | ✓ | ✓ |
| Specification of packaging (diagnostic products) | ✓ | ✓ | ✓ | ✓ |
| Specification and/or requirements of raw material | — | — | ✓ | ✓ |
| Pre-clinical studies | — | — | — | ✓ |
| Clinical Evidence and Clinical Evaluation | — | — | — | ✓ |
| Risk analysis and result of risk analysis | — | — | — | ✓ |
Form D
Instructions for Use
Packaging and labeling artwork
Explanation of symbols used on the device
Guidelines for use, training materials, installation & maintenance guidance
Batch / LOT / serial numbering system
List of accessories
Required for all classes A–D
Form E
Post Market Surveillance
Standard Operating Procedures, record management system, and product complaint handling procedure
Required for all classes A–D
Special requirements for certain product types
Radiation-emitting devices — Permit from BAPETEN (Nuclear Energy Regulatory Agency) required
Disposable sterile syringes — Local sterility test from an accredited laboratory in Indonesia required
Gauze, cotton, panty liner, sanitary napkin, adult diapers — Local fluorescence and absorption test from an accredited Indonesian laboratory required
Condoms — Local burst and leakage test from an accredited Indonesian laboratory required
HIV test products — Local clinical test result from RSCM (Cipto Mangunkusumo Hospital) required
Disinfectant products — Phenol coefficient test result from an accredited Indonesian laboratory required
Registration fee & timeline
The following figures are drawn from the official Kemenkes guideline (based on Government Regulation No. 21 Year 2013 on PNBP). Classification verification takes 7 calendar days for all classes. Duration is counted from the date of fixed receipt — issued after PNBP payment is confirmed.
| Type of service |
Class verification |
Evaluation (days) |
Fee (IDR) |
| New — Class A (low risk) | 7 days | 45 | 1,500,000 |
| New — Class B (low–medium risk) | 7 days | 90 | 3,000,000 |
| New — Class C (medium–high risk) | 7 days | 100 | 3,000,000 |
| New — Class D (high risk) | 7 days | 120 | 5,000,000 |
| Renewal / Variation — Class A | 7 days | 45 | 500,000 |
| Renewal / Variation — Class B | 7 days | 45 | 1,000,000 |
| Renewal / Variation — Class C | 7 days | 45 | 1,000,000 |
| Renewal / Variation — Class D | 7 days | 45 | 1,000,000 |
Key notes on renewal and variation applications
Renewal can be submitted up to 9 months before the marketing authorization expires. Renewals submitted after the expiry date are treated as new applications. Importers must also complete a distribution/importation report via e-report.alkes.kemkes.go.id before proceeding. Variation is only permitted while the current license is still valid. Variations allowed include: packaging, labeling, accessories/type/code/size additions, principal name or address changes (non-acquisition), and manufacturer name changes without address or ownership change. Class D devices additionally require hardcopy dossier submission at the counter.
Important note on this checklist
This checklist is based on the Pedoman Pelayanan Izin Edar Alat Kesehatan published by the Ministry of Health of the Republic of Indonesia (2016). Regulations governing medical device marketing authorization in Indonesia may be updated. Always verify current requirements against the latest circulars from the Directorate of Medical Device Evaluation (Direktorat Penilaian Alat Kesehatan dan PKRT) at regalkes.kemkes.go.id before submitting an application.
Need help preparing your registration documents?
INSIGHTOF Consulting Indonesia supports importers and foreign manufacturers through the full BPOM medical device marketing authorization process — from document review and KBRI legalization coordination to e-registration submission and follow-up at regalkes.kemkes.go.id.
