Animal-Derived and Non-Halal Materials in Medical Devices: Risks and Labelling

1. Key takeaways

Medical devices run into halal issues because animal-derived materials appear in devices far more often than companies expect. Research by the MUI Fatwa Commission and GAKESLAB Indonesia names concrete examples: surgical sutures, artificial heart valves, cardiac catheters, vascular grafts, vascular haemostatic devices and bone graft materials (used inside the body); wound dressings (direct human contact); and alcohol swabs (contain ethanol).

• The hidden risk sits in excipient sources. Plastic tubing, for example, may use fat-based plasticizers — the critical question is which animal the fat comes from, and if it comes from pigs, halal certification is impossible. Animal fat derivatives can also enter devices in the form of tallow, shortening and chicken fat, plus processed derivatives such as glycerol (E422), fatty acids and their derivatives, fatty acid salts or esters, magnesium stearate and other additives.
• Exemption follows nine criteria. Assessment can follow Kepkaban BPJPH 301/2026 (effective from 31 August 2026, established under PP 42/2024, Article 70). The core logic includes: natural or minimally processed; no risk of contact with non-halal substances; not protected flora or fauna; harmless and free of narcotics, psychotropic substances or nicotine; not prohibited; single component; does not change the raw material origin; and no additives or auxiliary substances added (or anything added is itself on the exemption list).
• There is a lawful alternative to certification: non-halal labelling. A product without a halal certificate must be clearly labelled as non-halal to continue circulating. Under PerBPJPH 3/2026, the deadline for non-halal relabelling of products already on the market is 23 July 2027. In other words: either certify, or label compliantly — there is no do-nothing option.
• Compliant labels follow three principles. ① Prominent marking (industry expectation is a conspicuous non-halal mark; specific requirements follow the current BPJPH rules); ② Indonesian language (this stacks on top of the mandatory Indonesian-language labelling requirement); ③ no misleading wording — vague phrasing that could be misread as halal is not acceptable.

2. Legal basis

The exemption framework rests on PP No. 42/2024, Article 70, which established the criteria that Kepkaban BPJPH 301/2026 operationalises with effect from 31 August 2026. The labelling route rests on PerBPJPH 3/2026, which fixes the non-halal relabelling deadline of 23 July 2027 for products already on the market and requires products without a halal certificate to be clearly marked as non-halal. The identification of at-risk device categories comes from the research of the MUI Fatwa Commission and GAKESLAB Indonesia, published in public materials of LPH LPPOM, which documents where animal-derived materials actually occur: implantables such as surgical sutures, artificial heart valves, cardiac catheters, vascular grafts, vascular haemostatic devices and bone graft materials, contact products such as wound dressings, and ethanol-bearing items such as alcohol swabs. The concrete visual design of the non-halal mark follows the current BPJPH rules, which companies must check at the time of labelling rather than assume.

3. Expert insights

The device industry consistently underestimates where animal derivatives hide. Companies scan their finished device for obvious animal content and stop there, but the documented examples run from implantables like heart valves and vascular grafts through contact products like wound dressings down to consumables like alcohol swabs. The subtler exposure is upstream: a fat-based plasticizer inside plastic tubing never appears on any marketing surface, yet the single question of which animal supplied that fat decides whether halal certification is possible at all. A pipeline that has never asked its suppliers this question does not know its own halal status.

The two-path structure means the decision is a portfolio decision, not a product-by-product accident. Certification and non-halal labelling are the only two lawful endings, and both require work: certification requires traceability and LPH audit scheduling, while labelling requires compliant marking by 23 July 2027. What does not exist is the outcome most companies tacitly hope for — doing nothing and continuing to sell. Products already on the market without a certificate face the earlier of the two clocks, because the relabelling deadline arrives before any of the deferred certification deadlines.

The traceability table is the highest-value document in the whole exercise. Built properly — component, source, whether animal-derived, animal species, supplier certificate, substitutability — it simultaneously serves three purposes: it is the factual basis for the certify-or-label decision, it feeds the exemption assessment under the nine Kepkaban criteria, and it is the strongest document available when customers or customs ask halal questions downstream. Companies that build it late assemble it under time pressure from unresponsive suppliers; companies that build it early turn it into a maintained asset.

4. Practical recommendations

• Build the full ingredient traceability table now. Structure it as component → source → animal-derived yes/no → animal species → supplier certificate → substitutable yes/no, and maintain it as a living document.
• Interrogate the excipient layer, not just the finished device. Ask suppliers specifically about fat-based plasticizers and additives such as glycerol (E422), fatty acid derivatives and magnesium stearate, and record which animal each fat originates from.
• Run the exemption screen for every simple product. Test each candidate against the nine Kepkaban BPJPH 301/2026 criteria to determine whether exemption is plausible before spending audit resources.
• Plan the non-halal label for products that will not certify. Design for prominence, Indonesian language and zero ambiguity, and complete the relabelling well before the 23 July 2027 deadline; confirm the exact mark design against the current BPJPH rules.
• File the self-check evidence even for clean products. Products confirmed free of animal-derived and ethanol or other sensitive ingredients should keep their verification materials on record for future inquiries.

5. Verification checklist

• □ Kepkaban BPJPH 301/2026 confirmed: nine exemption criteria, effective from 31 August 2026 (verified 26 October 2026)
• □ PerBPJPH 3/2026 confirmed: non-halal relabelling deadline 23 July 2027
• □ PP No. 42/2024, Article 70 confirmed: exemption criteria basis
• □ MUI Fatwa Commission and GAKESLAB Indonesia research on animal-derived devices reviewed (LPH LPPOM public materials)
• □ Ingredient traceability table completed for the full portfolio, animal-derived and ethanol risk points flagged
• □ Non-halal mark design confirmed against the current BPJPH rules

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com