Halal Certification for Medical Devices
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, medical devices, as items utilized by society, must also be certified halal.
Medical devices that require halal certification are those that originate from or contain animal-derived components. If a medical device contains forbidden substances, is made from non-halal sources, or is produced using processes that do not meet halal standards, the product must indicate its non-halal status. This indication involves providing information about the origin of materials on the device’s labeling. The details are as follows:
a. Medical Devices with Ingredients That Are Forbidden and Not Sourced from Halal Materials
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”
b. Medical Devices with Halal Ingredients but Produced with 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 Indonesia : “Proses belum halal”
In English : “Process not halal yet”
Reference:
Regulation of the Minister of Health of the Republic of Indonesia Number 3 of 2024
(https://farmalkes.kemkes.go.id/unduh/permenkes-3-2024/)