Classification System
How Indonesia classifies medical devices into four risk classes (A–D) using ASEAN/GHTF-aligned rules based on invasiveness, duration of contact, and intended use.
Class A — Low Risk
Class A medical devices in Indonesia — low-risk, simplified registration, examples, documentation requirements, and the October 2026 Halal labeling deadline.
Class B — Low to Moderate Risk
Class B medical devices in Indonesia — standard registration pathway, documentation requirements, timelines, and key examples.
Class C — Moderate to High Risk
Class C medical devices in Indonesia — full registration with clinical evaluation requirements, potential local clinical evidence, and timelines of 6–12 months.
Class D — High Risk
Class D medical devices in Indonesia — the highest risk category requiring full clinical data, traceability plans, and the most intensive Kemenkes review.
IVD Classification
How Indonesia classifies in-vitro diagnostic devices — risk-based rules for IVDs separate from the general Class A–D device framework.