Understanding the Malaysian halal certification framework for medical devices

Tukiran, Nur Azira and Basri, Katrul Nadia and Ahmad, Anis Najiha (2026) Understanding the Malaysian halal certification framework for medical devices. Halalsphere, 6 (2). pp. 91-95. E-ISSN 2773-6040

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Abstract

This short communication analyses Malaysia’s halal certification framework for medical devices using document analysis of the Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020 (MPPHM), as amended in 2026, the Malaysian Halal Management System 2020 (MHMS), MS 2636:2019, and relevant medical-device legislation. The analysis shows that halal certification functions as an additional assurance layer built upon regulatory compliance. Within this framework, MPPHM establishes regulatory eligibility through registration with the Medical Device Authority (MDA) or an exemption, and through establishment licensing. MHMS provides halal management through the Halal Assurance System (HAS) or Internal Halal Control System (IHCS). At the same time, MS 2636:2019 defines technical requirements for materials, manufacturing, premises, contamination control, packaging, traceability, and internal audit. Collectively, these documents integrate regulatory, certification, management, and technical controls to safeguard the halal integrity, safety, and quality of medical devices.

Item Type:	Article (Review)
Uncontrolled Keywords:	MPPHM 2020, MHMS 2020, MS 2636:2019, Medical Device Authority, Halal medical devices, Halal certification
Subjects:	BPH Islamic Economics > BPH117 Consumption. Halal issues. Standards. Certification. Halal status
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	International Institute for Halal Research and Training (INHART)
Depositing User:	Nur Azira Tukiran
Date Deposited:	04 Aug 2026 15:48
Last Update:	04 Aug 2026 15:48
Queue Number:	2026-07-Q4495
URI:	http://irep.iium.edu.my/id/eprint/130485

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