The Medical Device Authority (MDA) of Malaysia has announced a revision to MDA/GD/0026: Requirements for Labelling of Medical Devices, effective from 22 May 2026. This revision updates the requirements for foreign manufacturer information on medical device labels.
Under the revised guidance, foreign manufacturers are only required to include their name and address on the device label. Contact details such as an email address, telephone number, and/or website are now optional and may be provided for technical assistance purposes. This revision simplifies the mandatory labelling requirements while still ensuring that essential manufacturer information remains available. Manufacturers should review both their current and future product labels to ensure compliance with the updated guidance.
The revised labelling requirements may affect existing and future product labels for the Malaysian market. With local regulatory experts in Selangor, Qualtech supports organizations in label compliance reviews, regulatory strategy, and medical device registration. Contact us today to discuss your regulatory requirements.