In The Spotlight

Revise Scope of Malaysian Standard of Halal Medical Device

Announcements, News

22 Jan 2018

A Message from EUMCCI

Dear EUMCCI’s Board of Directors, Heads of Bilateral Members and Ambassadors of all the EU countries in Malaysia,

Last September, EUMCCI, through the Healthcare Committee, sent a feedback letter to the Department of Standards Malaysia to voice out our position regarding the proposed development of a Malaysian Standard on Halal Medical Devices and its requirements. Please find attached a copy of this letter for your reference.

We are glad to inform you that our letter managed to capture the attention of Datuk Fadilah, Director General of the Department of Standards Malaysia who called us for a meeting on the 15th of January together with other stakeholders like APACMed, MMI, AMMI, MDA, JAKIM, MINDEF, MoF and MoH Procurement Division.

During the meeting, EUMCCI and AMMI proposed for the Department of Standards Malaysia to limit the scope of the new Halal standard to medical devices that contain materials derived from animal sources and exclude any material/tools/process utilised throughout the manufacturing process.

During the meeting, EUMCCI and AMMI proposed for the Department of Standards Malaysia to limit the scope of the new Halal standard to medical devices that contain materials derived from animal sources and exclude any material/tools/process utilised throughout the manufacturing process.

As a result of our collective advocacy effort, the Departments of Standards Malaysia have revised the previously proposed scope to this new version.

“This Malaysian Standard specifies the requirements in the manufacturing and handling of particular medical devices as specified by the halal competent authority for the purpose of halal certification”.

FYI, the use of these Halal Malaysian Standards is voluntary except if they are made mandatory by regulatory authorities by means of regulations, local by-laws or any other similar ways.

Furthermore, the Departments of Standards Malaysia have requested EUMCCI and other industry players/associations to help them defining better the terms ”particular medical devices” to ensure there is no ambiguity on the scope.

EUMCCI will coordinate and compile all the proposed definitions before we submit to the Department of Standards Malaysia. Therefore, we would be very grateful if you could submit your feedback by 25th of January 2018 to EUMCCI’s Advocacy Manager, Noor Asmaliza via email: asmaliza@eumcci.com.

Besides EUMCCI’s feedback’s letter, we hereby attach the presentation of the Department of Standards which gives you the background of the development of Halal standards.