Medical device labeling requirements in Indonesia are outlined by the Ministry of Health (MoH). In Indonesia, Independent License Holders have the ability to label medical devices for their customers. Labels can be affixed to medical devices after customs clearance.
All products should be labeled in English. It is preferred that products intended for home use are labeled in Bahasa Indonesian, but it is not required.
Medical Device Labeling Requirements
Labels may be in the form of pictures, colors, writing, or a combination thereof.
The label must contain at minimum:
Product name and/or trade name
Name and address of the company main components
Intended use and Instructions For Use (IFU) in Indonesian
IFU must contain: (Minimum intended use/function, instructions for use, contraindications, attention and warnings (written in Bahasa))
Warnings in Bahasa Indonesian
Batch or lot number
Marketing license number Regulation Regarding Medical Devices, Arts. 26
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