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The significance of Indonesian HALAL certification regulations for medical devices
2025-05-15
As Indonesia continues to rely on imported medical devices to support its healthcare sector, there is a need to provide Halal product assurance for medical devices that use animal products. The Indonesian government recently issued Halal Regulation No. 39, titled “Implementation of Halal Product Assurance,” to ensure compliance by medical device manufacturers.
Currently, Halal certification for medical devices is voluntary. However, according to the newly implemented Halal Regulation No. 39, medical devices containing animal-derived materials (ADM) will be required to undergo Halal certification registration according to the following timeline. Halal certification is valid for four years.
To date, many imported medical devices incorporate a range of materials into the finished product, including animal tissue and other animal-derived materials. These ADMs are common and are primarily used in polymers to stabilize formulations or to create medical device components such as coatings, tubing, connectors, and packaging.
AMD can also form a significant portion of finished devices, such as bovine heart valves, bone substitutes, and collagen injections. Furthermore, fibers and resins commonly used in the medical industry, such as PVC, PP, PVC, Acetal, TPU, TPV, and PE, may also contain ADM. Protogastric, gelatin, collagen, tallow, wool, fat, bone, heart valves, pericardium, chondroitin sulfate, subgut mucosa, pericardial chitosan, and hyaluronic acid are examples of animal-derived technologies currently used in various clinical applications.
Despite the therapeutic and biocompatibility advantages of animal materials compared to non-animal materials, the use of animal materials in medical devices is a growing concern among the Muslim population.
Impact of Halal Regulation on Medical Devices Containing ADM
Since October 2019, the obligation to halal certify medical devices containing ADM has been in place. During various transitional periods, medical devices that have not yet been halal certified can be circulated in Indonesia without specific labeling. However, once the respective transitional period has passed, all products in that risk category must comply with halal certification requirements, including labeling indicating whether the medical device containing ADM is halal certified or not.
Special considerations
If a medical device is not Halal certified but is the sole standard of care for a treatment, it is allowed to be placed on the market, but must be labeled with a special label. According to Halal Regulation No. 39, companies must use different colors to indicate the composition of ingredients. Furthermore, according to the Indonesian Halal Law (GR 33/2014) and the Indonesian Halal Certification Regulation 2019 (GR 31/2019), companies must label their haram ingredients in red.
Indonesian Halal Certification Process
According to the new regulations, Halal certification in Indonesia is as follows:
Phase 1: Establishment of HAS system
The organization establishes the HAS system based on the HAS standard.
Phase 2: Submit application for Halal certification to BPJPH
1. After the organization completes the HAS system, submit an application to BPJPH and fill in the application materials.
2. Halal auditors audit the business.
Phase 3: BPJPH determines the product status (Halal or non-Halal)
Halal product certification: BPJPH issues Halal certificates within 1 day
Non-Halal Product Designation: BPJPH issues a non-Halal declaration letter within 1 (1) day.
What manufacturers or distributors must know when applying for a Halal certificate in Indonesia
Each raw material used in a medical device does not need to apply for a separate Halal certificate, but the medical device must comply with the new Halal regulations.
If you need Indonesian BPJPH-HALAL certification services, please contact us.