In accordance with Indonesian regulations, all products entering, circulating, and being traded within Indonesia must have halal certification. This requirement extends to various goods and services, including food, beverages, pharmaceuticals, cosmetics, chemical products, biological products, genetic engineering products, and items used by the public. Consequently, society must also certify medical devices as halal.
Medical Devices Requiring Halal Certification
Medical devices that require halal certification are those originating from or containing animal-derived components. If a medical device contains forbidden substances, comes from non-halal sources, or undergoes processes that do not meet halal standards, the product must indicate its non-halal status. This indication requires the manufacturer to provide information about the origin of materials on the device’s labeling.
Labeling for Non-Halal Medical Devices
Medical Devices with Forbidden Ingredients
For medical devices containing forbidden ingredients or materials not sourced from halal sources, the non-halal label must display the name of the ingredient in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Forbidden materials include carrion, blood, pork, and/or animals slaughtered in a manner not compliant with Islamic law. An example of how to label this information is as follows:
- In Indonesia: “Bahan tidak halal”
- In English: “Non-halal ingredients”
Medical Devices with Halal Ingredients but Non-Halal Processes
For medical devices made from halal ingredients but manufactured using non-halal processes, the non-halal label must indicate the origin of the materials with the ingredient name in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Such devices are made with materials that have halal certification but involve the use or contact with forbidden materials during the manufacturing process. An example of how to label this information is as follows:
In English: “Process not halal yet”
In Indonesia: “Proses belum halal”
Reference:
Regulation of the Minister of Health of the Republic of Indonesia Number 3 of 2024
