Market Intelligence
Medical Devices Malaysia Laws and Regulations

Malaysia Halal Certification

More than 60 percent of the Malaysian population practices Islam as their religion. Malaysia has developed a detailed halal certification for medical devices.

In Malaysia, the medical device market is valued at over $1.4 billion. With more than 60 percent of the Malaysian population practicing Islam as their religion, Malaysia has developed a detailed halal certification for medical devices that meet requirements prescribed by the Islamic Sharia law. Companies that meet those Halal requirements may benefit from the growing market opportunity in the medical device sector.

To be considered Halal under the Malaysian system, products must be made from materials or ingredients allowed under Sharia law. For the Malaysian market, Halal certification must be issued by the Department of Islamic Development Malaysia (JAKIM). While it is not compulsory for all manufacturers who market their devices in Malaysia to get their devices Halal-certified, those medical devices with Halal certifications would be preferred over other non-certified products.

Local distributors can apply for the Halal medical device certification on behalf of a U.S. manufacturer, but the Halal certification belongs to the local distributors.

For more information on opportunities in the Malaysian healthcare sector, contact Bethany Tien at office.kualalumpur@trade.gov
 

05/11/2022