Labeling Requirements
Mandatory elements for medical device labels in Indonesia — NIE number, Bahasa Indonesia content, IFU requirements, and packaging levels.
Bahasa Indonesia Rules
Mandatory Bahasa Indonesia language requirements for medical device labels and IFU in Indonesia — what must be in BI, what can be bilingual, and consequences of non-compliance.
Halal Labeling (GR 42/2024)
Indonesia's phased mandatory Halal labeling compliance requirements under Government Regulation 42/2024 — deadlines by class, non-halal declaration rules, and preparation steps.
e-Labeling (Permenkes 11/2025)
Indonesia's e-labeling provisions under Permenkes 11/2025 — when electronic IFU is permitted, physical label requirements that remain, and compliance approaches.