Medical devices marketed in Indonesia will be subject to certification that they are free of animal materials whose consumption is forbidden by Islamic law, under a new regulation issued in February by the government of the country with the largest population of Muslims in the world.
The regulation extends Indonesia’s two-year-old Halal Product Law to medical devices that contain products derived from animals. The Halal Law regulates the processing and materials of products, both edible and non-edible, to ensure they are halal, or “permissible” under the tenets of Islam. That means products can’t contain a long and specific list of animal materials, including pork, birds of prey, and animals slaughtered in ways considered inhumane.
Many medical devices contain materials derived from animals, from bovine heart valves to gelatin, collagen, tallow, and wool. Some such materials are used in polymers that remanufactured into coatings, packaging, fibers, and resin utilized in medical products. More than 225 million people in Indonesia—more than 86% of the population—identify as Muslim.
Under the new regulation, medical devices must be granted certification from the Indonesia Ulema Council (MUI), the institution that issues halal certifications, starting in October 2026. The compliance start date applies to devices deemed low risk, while those deemed moderate to high risk have until 2034 to attain the certification. The new regulation does not entirely forbid the circulation and sale of medical devices that are not halal certified. Where a device is the only such product available to treat a specific condition, its use will be allowed, if it is clearly labeled as non-halal certified.