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Malaysia MDA Publishes Draft Guidance on Notification of Custom-made Medical Devices

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December 5, 2022

The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products when seeking permission to import or place them in the Malaysian market. The draft document Notification of Custom-Made Medical Devices describes the notification process for manufacturers.

A custom-made medical device is defined as a medical device with a specific design characteristic that is made in accordance with a medical practitioner’s written prescription and is intended to be used by a particular patient.

Interested manufacturers must submit the notification form with a written prescription provided by a medical practitioner and must include details of the device. The notification can be sent via email to [email protected]

In addition, a non-refundable administrative charge of RM 300 will be issued upon receipt of the application and must be paid within 30 days. Successful applications will receive a no-restriction letter notifying you that the product may be imported or placed in the Malaysian market.