Ministry of Health (Kemenkes)
The role of the Indonesian Ministry of Health (Kementerian Kesehatan) as the primary regulator for medical device registration, NIE issuance, and market surveillance.
BPOM / NADFC
The role of Indonesia's National Agency of Drug and Food Control (BPOM/NADFC) in the medical device regulatory system — GMP inspections, clinical trials, and its relationship with Kemenkes.
Directorate of Medical Devices
The operational unit within Kemenkes responsible for evaluating device registration dossiers, issuing NIEs, and overseeing distribution and post-market compliance.