Bahasa Indonesia Language Requirements
The Core Rule
All safety-critical information on medical device labels and IFU must be available in Bahasa Indonesia. This is a non-negotiable requirement enforced at both the registration review stage (Kemenkes label approval) and in the market through post-market sampling.
What Must Be in Bahasa Indonesia
| Content Type | BI Required? |
|---|---|
| Warnings | Mandatory |
| Contraindications | Mandatory |
| Side effects / adverse effects | Mandatory |
| Primary operating instructions | Mandatory |
| Storage and handling instructions | Mandatory |
| Sterility and single-use statements | Mandatory |
| Device name | Yes (or BI equivalent alongside English trade name) |
| Manufacturer / distributor details | Acceptable in English |
| Technical specifications | English acceptable alongside BI |
| Catalogue numbers, lot numbers | No BI requirement |
Bilingual Labels (BI + English)
Bilingual labeling is widely used and accepted by Kemenkes. Many international brands run a bilingual IFU with Bahasa Indonesia and English in parallel columns or sections. This approach is:
- Practical for global label management
- Acceptable to Kemenkes provided BI safety content is prominent and complete
- Required even if the primary intended users are medical professionals (there is no professional-use exemption from the BI requirement)
Common Rejection Reasons Related to Language
- Safety warnings present only in English — rejected
- IFU where Bahasa Indonesia translation is abbreviated or incomplete — queries raised
- BI translation that is inaccurate or misleading — rejected
- Label where English text is significantly larger or more prominent than BI equivalent for safety information — may trigger query
Market Sampling Enforcement
Kemenkes conducts market sampling — purchasing products from hospitals, pharmacies, and medical supply distributors — and checking the label against the approved label in the Regalkes system. Non-compliance with BI requirements found during market sampling triggers the sanctions process (warning → NIE suspension → NIE revocation + recall).
Translation Quality
The quality of Bahasa Indonesia translation matters. Kemenkes evaluators are native speakers and will identify:
- Machine translation that is grammatically incorrect or contextually inaccurate
- Medical terminology that is inconsistent with Indonesian clinical practice
- Safety statements that are ambiguous when translated
Use qualified Indonesian medical translators for all BI label and IFU content. Have the translation reviewed by a local regulatory affairs professional before submission.
Reference the Kamus Istilah Kesehatan (Indonesian Health Terminology Dictionary) published by Kemenkes or consult with Indonesian regulatory affairs specialists who maintain current terminology databases. Inconsistency in medical term translation (e.g., using different Indonesian terms for the same device function across the IFU) is a common reason for label revision requests during review.