NIE Registration
The Nomor Izin Edar (NIE) — Indonesia's mandatory marketing authorisation for medical devices. What it is, who holds it, and key rules governing its use.
Registration Pathways
The registration pathways available for medical devices in Indonesia — standard by class, expedited using foreign approvals, and simplified notification for Class A.
IDAK — Distribution Licence
The IDAK (Izin Distribusi Alat Kesehatan) — Indonesia's mandatory medical device distribution licence. Requirements, application process, and its relationship to the NIE.
CDAKB — Good Distribution Practice
The CDAKB (Cara Distribusi Alat Kesehatan yang Baik) certificate — Indonesia's Good Distribution Practice requirement for medical device distributors, mandatory since July 2024.
Timelines & Fees
Indicative review timelines by device class for NIE registration in Indonesia, PNBP government fees, and the payment process via the Regalkes portal.