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 management and embeds or integrates the requirements of Halal as part of the overall management and control systems in 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, ensuring 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, which are incorporated into halal standards which can be in the form of the standards developed by Department of Standards Malaysia and also International Standards such as ISO. Halal should not be tested into products but should be built-in into the management system.
This Malaysian Standard specifies the requirements in the manufacturing and handling of medical device for the purpose of halal certification.
1st August – 30th September 2017
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 : + 603-83191473 (Ms. Fakheezah Borhan) or
+ 603-83180039 (Mr. Mohd Shafiq Mohd Zakaria)
Fax: + 603-83191511
All your views and comments are highly appreciated and preceded by thanks.