Emergency Use Authorization
Indonesia's emergency use authorization (EUA) pathway for medical devices — eligibility, documentation, approval scope, and post-emergency transition.
Compassionate Use
Accessing unregistered medical devices in Indonesia for individual patients with serious or life-threatening conditions where no registered alternative exists.
Import for Research
How to import unregistered medical devices for clinical investigations in Indonesia — BPOM authorisation, ethics committee approval, GCP requirements, and per-shipment import permits (SKI).