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.