KATRUL NADIA BASRI

International Institute for Halal Research and Training( INHART) International Islamic University Malaysia( IIUM)

ANIS NAJIHA AHMAD

International Institute for Halal Research and Training( INHART) International Islamic University Malaysia( IIUM)

Medical devices are used in the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The increasing prevalence of chronic illnesses and the global shift toward early detection have driven the rising adoption of advanced medical technologies.

But within this growth lies a quieter question: How do these innovations align with Islamic principles? For Muslims, medical care is not just about function— it is about faith. As the field advances, halal compliance in medical devices is no longer a secondary concern; it has become a primary consideration. It is an emerging standard.

HALAL DEVICES

As demand for medical devices continues to rise, ensuring their halal compliance becomes essential- especially for Muslim users. In Islam, a product is considered halal( permissible) when it is lawful and toyyib( good), as stated in Qur ' an 2:168, and complies with Islamic legal and ethical principles.

“ O mankind, eat from whatever is on earth [ that is ] lawful( halal) and good( toyyib) and do not follow the footsteps of satan. Indeed, he is to you a clear enemy”( Quran, Al-Baqarah, 2:168) Beyond ingredients, halal compliance also encompasses the processing, manufacturing, handling, and storage of a product. The entire supply chain must be free from impure or haram materials, directly or indirectly. Equipment used must not have been exposed to non-halal substances unless it has undergone proper Islamic cleansing( sertu) procedures.

The application of halal principles in medical devices includes evaluating raw materials, manufacturing environments, and ethical integrity. For example, the use of human body parts without medical necessity or ethical justification is prohibited under Islamic law. In this context, halal is not limited to ingredients- it encompasses the purpose, integrity, and moral framework of the entire product.

CONVENTIONAL DEVICES

Many conventional medical devices, especially those used in implants or with coatings, may contain animal-derived substances that raise halal concerns. For example, gelatin, commonly used in capsule coatings or wound dressings, is often sourced from pigs unless otherwise specified.

Similarly, collagen, sutures, or biological implants, such as heart valves, may originate from non-halal animals. To be halal, animal-derived materials must come from animals slaughtered in accordance with Islamic procedures( zabiha). This ensures that the material is both physically safe and halal( permissible).

Alcohol-based substances also pose questions. While alcohol is prohibited for consumption, external medical uses are permissible under specific conditions. Devices involving human-derived tissues

, such as bone grafts or skin patches, also present complex halal authentication challenges.

Halal compliance goes beyond materials. The entire production environment, including packaging and logistics, must be free from contamination by non-halal substances. Shared manufacturing lines must be thoroughly cleansed to maintain integrity.

Given the complexities, verifying the halal status of medical devices is crucial- not only to fulfil religious obligations but also to foster consumer trust, expand new markets, and meet rising ethical expectations in global healthcare.

PRINCIPLE TO PRACTICE

Malaysia has taken a pioneering role in formalising the certification of halal medical devices through the introduction of MS 2636:2019, " Halal Medical Devices: General Requirements."

MS 2636:2019 defines a halal medical device as one that is free from haram( forbidden) or najis( impure) substances, is safe for use, and is produced, handled, and stored in accordance with Islamic principles( Department of Standards Malaysia, 2019).

The standard sets precise requirements for sourcing and production, with particular attention given to animal-derived materials, such as gelatin, collagen, or tissue grafts, which must originate from animals slaughtered in accordance with Islamic law. Humanderived materials are only permissible under strict ethical and religious conditions, usually in cases of medical necessity.

A key strength of MS 2636:2019 is its alignment with internationally recognised standards, particularly ISO 13485, which governs quality management systems for medical devices. This integration ensures that halal-certified products do not compromise on safety or performance and meet global regulatory expectations.

Traceability is a critical component of MS 2636:2019, which mandates that every stage of the product’ s lifecycle, from sourcing to end-user delivery, must be documented and auditable to maintain halal integrity.

Hygiene protocols must align with both Islamic requirements and industrial standards such as Good Manufacturing Practices( GMP). A risk