Halal certification of medical device in Malaysia: A shariah analysis into the compliance process and legal requirements Draman Wan Mohd Ashraf Adlin Wan1,,*, Chun-Phuoc Jeong2, Yajid Mohd Shukri Ab2 1The International Centre for Halal Studies, Management & Science University, Selangor, Malaysia 2Post Graduate Centre, Management & Science University, Selangor, Malaysia *Corresponding Author Wan Mohd Ashraf Adlin Wan Draman The International Centre for Halal Studies, Management & Science University, Shah Alam, Selangor, Malaysia, e-mail: wan.ashraf@msu.edu.my
Online published on 1 May, 2020. Abstract The manufacture, marketing and use of medical instrumentations and devices (‘medical device’) is a big business on a global scale-in Malaysia and elsewhere in Asia-Pacific region. Medical manufacturers of these devices in Muslim majority countries are required to address both not only ethical issue but also Halal certification of such devices. Growing consumer trends among Muslim consumers for Halal certification of food and products now appears to have expanded into medical device due to increased Halal awareness among Muslim consumers. The business need for Halal certification as part of global business strategy for manufacturers, importers and exporters has now become an integral part of business strategic decision process. The main objective of this research is to explore the needs of laws and regulation and syariah compliance process in a journey of Halal certification in various categories, such as the use of medical devices and providing halal supports for business rationality in the making of Halal medical to be part of Halal Economy in 21st Century. Top Keywords Manufacturer, Medical Device, ethical issue, legal compliance, process, Shariah perspective, Halal built-in concept, Halal Medical Device Standard 2018(draft), management system, ISO 13458, Medical Device Act 2012, Strategy, 21st century Halal Economy. Top |