Understanding the Malaysian halal certification framework for medical devices

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.