Indonesia

Local Labeling Services

Indonesia Medical Device Labeling

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.

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
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
Expiration date
Batch or lot number
Marketing License (AKL Number)

Contact Asia Actual to see if our Indonesia labeling solutions are right for your needs.

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US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Indonesia@asiaactual.com

Indonesia

Indonesia Medical Device Labeling

Medical Device Labeling Requirements

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