Malaysia To Standardize Certification Of Halal Medical Devices

Responding to the needs of more than 61% of citizens who identify as Muslim, Malaysia is set to launch an online system to standardize the certification of medical devices that adhere to the requirements of Islamic law. Under the Islamic requirements, known as halal,  products can’t contain a long and specific list of animal materials, including pork, birds of prey, and animals slaughtered in ways considered inhumane.

The system, to be managed as an online platform by the Malaysian Islamic Development Department, is designed to ensure medical devices marketed in the country as halal are produced separately from those that do not meet halal requirements.

Many medical devices contain materials derived from animals, from bovine heart valves to gelatin, collagen, tallow, and wool. Some such materials are used in polymers that are remanufactured into coatings, packaging, fibers, and resin utilized in medical products.

Unlike neighboring Indonesia, where non-halal medical devices have been prohibited since 2019, Malaysia does not forbid the sale of medical products that contain ingredients prohibited under Islamic law. But as demand for halal devices has grown, so has the need for a certification pathway and regulatory controls.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.