Halal medical device – General requirements
The Malaysian Standards relating to halal have been developed to meet the challenges of the growing demand for halal products and services, to complement the halal ecosystem within Malaysia. This standard was formulated based on the concept of halal built-in and used by existing competent authorities towards halal certification.
Halal built-in is a systematic approach to halal product development which begins with predefined objectives by the management. It embeds or integrates the requirements of halal as part of the overall management and control systems. It includes all aspect of manufacturing/ production, from strategy/ planning to research and development to raw material sourcing until delivery of finished product to its point of purchase. This ensures continuous compliance to the specific halal requirements and the aspects of product safety, performance, efficacy/effectiveness and quality, along with the hygienic aspects in manufacturing and handling of the halal product.
Halal requirements are as stated by Shariah and fatwa that are incorporated into halal standards which are in the form of the standards developed by Department of Standards Malaysia and also International Standards such as developed by ISO. Halal should be built-in into the entire system.
Obtaining halal certification is a business strategy and is seen as a value added element. Since, the main requirements of all medical devices are there its safety and performance as such, all medical devices has to comply with the Medical Device Act 2012 (Act 737) before they can be certified halal.
16 April 2018 – 15 June 2018
The draft of MS for public comments can be downloaded free of charge. Please click HERE to download the document.
If you would like to make any comments on the draft of MS, kindly use the provided form. (Please click HERE to download the form)
For more information, you may contact us through the following information: -
Department of Standards Malaysia
Level 1 & 2, Block 2300
63000 Cyberjaya, Selangor
Tel: + 603-83191424 (Ms. Nor Jalilah Md Yusop)
Fax: + 603-83191511
All your views and comments are highly appreciated and preceded by thanks.