Labeling Requirements
Overview
Medical device labeling in Indonesia must comply with requirements set by Kemenkes under Permenkes No. 62/2017 and the supplementary labeling regulation Permenkes No. 11/2025. All labels submitted with the registration dossier are reviewed by Kemenkes evaluators and must be approved before the device can be distributed.
Mandatory Label Elements
The following information must appear on all medical device labels:
| Element | Notes |
|---|---|
| Device name / trade name | As registered; consistent with dossier |
| NIE number | Must be printed on all packaging including the smallest unit; added after NIE is issued |
| Manufacturer name and address | Exact legal name; consistent with other documents |
| Local LAR/distributor name and address | Indonesian entity details |
| Intended use / indications | Brief statement |
| Lot/batch number | Traceable to production records |
| Expiry date or manufacturing date | As applicable; format: month/year minimum |
| Storage conditions | Temperature, humidity as applicable |
| Sterility statement | If supplied sterile: "STERILE" and method |
| Single use statement | If applicable: "FOR SINGLE USE ONLY" / Sekali Pakai |
| Quantity / content | Number of items in pack |
| Country of manufacture | |
| Warnings and contraindications | In Bahasa Indonesia — mandatory |
Packaging Levels
Labels must be compliant at all packaging levels:
- Innermost (unit) packaging
- Intermediate packaging
- Outer/secondary packaging
- All levels must bear the NIE number once issued
IFU Requirements
The Instructions for Use (IFU) must include:
- Full intended use and indications
- Contraindications
- Warnings and precautions
- Step-by-step operating instructions
- Cleaning and maintenance instructions (if applicable)
- Disposal instructions
- Storage conditions
- Technical specifications
- Symbol glossary (if symbols are used)
Language: Bahasa Indonesia is mandatory for all safety-critical IFU content. Bilingual (Bahasa Indonesia + English) is acceptable.
NIE Number on Packaging
After the NIE is issued, the NIE number must be incorporated into all product labels before any import or distribution. This requires:
- Updating artwork with the NIE number
- Submitting the updated label to Kemenkes if the change is material
- Ensuring field stock carries the approved NIE-bearing label
Kemenkes conducts market sampling to verify that the label on products in hospitals and pharmacies matches the approved label in Regalkes.