|
management framework must also be in place to identify, control, and respond to any threats to the halal status of the product.
In Malaysia, any medical device must be approved by the Medical Device Authority( MDA), as stipulated under the Medical Device Act 2012( Act 737) and the Medical Device Regulations 2012. These regulations are in place to ensure that all medical devices used within the country meet strict standards of safety, quality, and performance.
HURDLES
Despite having standards in place, implementing halal standards in medical devices faces several notable challenges: Global supply chain complexity: Modern medical devices often comprise components sourced from multiple countries, making it difficult to verify the halal status of every material and process involved. This global interconnectivity can obscure the origins of raw materials, mainly when animal-derived ingredients or additives are used. Limited technical awareness: Many manufacturers, particularly those outside the Muslim world, may be unfamiliar with Islamic requirements and may not prioritise halal compliance. Lack of consumer demand: The lack of consumer awareness regarding the use of halal medical devices presents a significant challenge, as many consumers continue to opt for conventional alternatives. As noted by Noorul Huda Sahari et al.( 2021), awareness had the weakest positive correlation with the use of halal medical devices, suggesting that current awareness efforts are insufficient to drive meaningful behavioural change. Limited availability of halal alternatives: Developing or sourcing halal-certified options( such as gelatin or collagen derived from permissible sources) can be complex, expensive, or technologically demanding. This discourages many manufacturers from pursuing halal certification. Regulatory inconsistency across countries: Although countries like Malaysia have established comprehensive halal medical device standards, other countries, particularly those not adhering to Islamic principles, lack specific guidelines for halal medical devices. This inconsistency creates confusion for international manufacturers and hinders global trade in halalcertified medical devices.
These challenges necessitate greater coordination and the involvement of international regulatory bodies to advance the halal medical device industry sustainably.
|
OPPORTUNITIES
Despite the challenges facing the halal medical device sector, there are significant opportunities for growth and innovation that can shape its future trajectory. One of the most promising areas lies in the development of Halalcompliant biomaterials.
Biomedical research can be directed toward creating materials derived from plant-based sources or synthetic polymers, which eliminate the ambiguity associated with animal-derived substances. In cases where animal-based components are necessary, switching to halal-slaughtered bovine tissues offers a viable alternative.
Furthermore, countries with strong Islamic economies, such as Malaysia, the United Arab Emirates, and Indonesia,
|
have the potential to become global hubs for halal medical devices. These nations can invest in establishing halal-focused research and development ecosystems that encourage innovation while maintaining religious compliance.
Strategic cross-sector collaboration between academia, industry, regulatory bodies, and halal certification agencies can drive the commercialisation of compliant technologies. This can also support the creation of export-oriented solutions that meet international halal standards, positioning these countries as leaders in the global halal medical device market.
BLOCKCHAIN
The application of blockchain technology in halal medical devices represents a transformative advancement in ensuring transparency, traceability, and integrity within the halal supply chain. In the context of halal compliance, especially for medical devices that may contain animal-derived materials or undergo complex global manufacturing processes, verifying Halal status at every stage is crucial.
Blockchain offers a decentralised and tamper-proof ledger system that allows all stakeholders, including manufacturers
|
, halal certification bodies, regulators, and end-users, to access real-time, immutable records of origin for each ingredient, as well as processing and certification history.
For example, when a medical device component is sourced, blockchain can log whether it came from a halalcertified supplier, whether it was handled according to Shariah-compliant procedures, and when it received official certification.
This level of visibility enhances trust in halal certification and significantly reduces the risk of fraud, contamination, or non-compliance. Furthermore, blockchain can automate verification through smart contracts, ensuring that only components meeting halal standards proceed to the next stage of production.
GLOBAL STANDARD
The incorporation of halal principles into the medical device industry represents a crucial convergence of faith, ethics, and science. By harmonising Islamic values with ISO-based best practices, the standard offers a dual benefit: it assures Muslim consumers of religious compliance while maintaining highquality production standards acceptable worldwide.
While still in its infancy, the movement toward halal-certified medical devices responds to a real need in Muslim communities for products that align with their religious beliefs and health values.
It provides manufacturers with a strategic advantage in accessing the global halal market, strengthening consumer confidence, and promoting ethical and transparent supply chains. Success in this domain requires collaboration among stakeholders, including engineers, manufacturers, Shariah experts, regulatory bodies, and policymakers.
With structured guidelines, rigorous certification, and proactive innovation, the future of halal medical devices holds promise not just for Muslims, but for global markets seeking ethical and highquality healthcare solutions.- The HEALTH
|
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." |