The two-licence structure
You need both the IDAK distributor licence and the per-product Izin Edar (NIE) before commercial distribution.
Free field guide · PDF
Indonesia Kemenkes Medical Device Registration2026 Field Guide
Izin Edar, the LAR rule, and the October 2026 halal deadline — for ASEAN's 280-million-person market.
- Halal deadline
- 18 Oct 2026
- Class D evaluation
- 45 days
- Class D fee
- IDR 5M
Sourced from Kemenkes 2026 registration guidance and 2026 halal regulation.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Kemenkes 2026 registration guidance and 2026 halal regulation.
The evaluation clock
Imported-device evaluation periods from 15 days (Class A) to 45 days (Class D), with the class fee ladder.
The halal deadline
Mandatory halal certification takes effect 18 October 2026 — Risk Class A devices are in scope.
Sources & scope
- investindonesia.co.id, mandatory halal certification October 2026.
- peraturan.go.id, Regulation of the Minister of Health.
- indonesia.incorp.asia, Izin Distribusi Alat Kesehatan in 2026.
- ahwp.info, Annex 14 Indonesia.
- IBA, healthcare and life sciences law committee survey 2026.
This guide is market-access intelligence, not regulatory or legal advice. Kemenkes timelines, fees, and halal requirements are product-specific — professional review is required before business use.
Market Access Strategy Session
Indonesia on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your Kemenkes route — distributor licensing, Izin Edar sequencing, and the halal compliance plan.
Professional review is required before business use.
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