Timelines & Fees
Review Timelines
Registration timelines in Indonesia vary significantly by risk class, dossier completeness, and current Kemenkes workload. The following are indicative timelines for well-prepared, complete submissions:
| Class | Administrative Review | Technical Review | Total (Indicative) |
|---|---|---|---|
| A | 5–10 working days | 10–20 working days | ~15–30 working days |
| B | 10–15 working days | 2–4 months | 3–6 months |
| C | 10–15 working days | 4–9 months | 6–12 months |
| D | 10–15 working days | 6–10+ months | 6–12+ months |
These timelines assume a complete and well-prepared dossier. Incomplete submissions, document inconsistencies, or slow responses to clarification queries can add months to the process. At least one round of clarification queries from Kemenkes evaluators should be expected.
Additionally, the Regalkes portal has periodic maintenance shutdowns — plan submissions to avoid these windows.
What Extends Timelines
- Document legalisation delays: Embassy apostille/legalisation of LoA, CFS, and GMP certificates frequently adds 3–6 months to pre-submission preparation
- Document inconsistencies: Name or address mismatches across documents are one of the most common causes of administrative rejection and re-submission
- Clarification responses: Slow or incomplete responses to MoH queries extend review
- Regalkes maintenance: Portal shutdowns temporarily halt applications
- Class C/D local evidence requests: If Kemenkes requests local performance data, this adds significant time
PNBP Government Fees
Registration fees in Indonesia are structured as PNBP (Penerimaan Negara Bukan Pajak — Non-Tax Government Revenue). Fee levels are set by government regulation and vary by:
- Device risk class
- Whether the application is a new registration, renewal, or change notification
Payment process:
- Once an application passes the administrative review phase in Regalkes, a billing notice is generated in the portal
- The IDAK holder makes payment through the designated government payment system
- Payment confirmation unlocks the technical review phase
Fees are payable only after passing administrative review — you do not pay upfront at the time of submission. Keep payment processes in mind as delays in payment will stall the technical review.
Contact Kemenkes or consult the current PNBP regulation for up-to-date fee schedules, as these are subject to revision by government decree.
Overall Pre-Launch Timeline Planning
A realistic end-to-end timeline for a new Class B device from a foreign manufacturer with no prior Indonesian presence:
| Activity | Estimated Duration |
|---|---|
| LAR selection and appointment | 1–3 months |
| LAR IDAK + CDAKB setup (if new entity) | 3–6 months |
| Document preparation, legalisation, apostille | 3–6 months |
| CSDT dossier assembly and translation | 1–3 months |
| Regalkes submission and administrative review | 1–2 months |
| Technical review + clarification rounds | 2–4 months |
| Total | ~12–24 months |
For Class C/D devices, add 3–6+ months to the technical review phase, and potentially more if local clinical data is requested.