Indonesia medical device registration timeline
Source-linked clocksMinistry of Health (MoH) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class A(Notification) Official service-standard clock for imported Class A izin edar (new application): 15 working days of evaluation (evaluation guideline Annex 8) | 15 working days | 2-4 months | — | Verified |
| Class B(Registration) Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8) | 30 working days | 4-6 months | — | Verified |
| Class C(Full Registration) Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8) | 30 working days | 4-6 months | — | Verified |
| Class D(Full Registration) Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8) | 45 working days | 5-7 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesIndonesia Medical Device Registration Process
Step-by-step MoH registration process. Total estimated timeline: 2-4 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a Indonesia Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MoH including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMoH reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
15 working daysIn-depth technical assessment of device safety and performance. MoH may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MoH issues Indonesia market authorization certificate.
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
Eligibility: Any device filed in an ASEAN member state that has transposed the AMDD into national law
- Indonesia Authorized Representative
- Bahasa Indonesia labeling
- Local testing from accredited labs
- ISO 13485 certification
- Free Sale Certificate
- Annex 8 additional clocks: additional-data evaluation 10 working days (Class A/B) or 15 (Class C/D); renewal 7 working days; variation (perubahan) 10 working days
Reviewed 2026-08-30. End-to-end totals remain planning estimates.