The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products when seeking permission to import or place them in the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…
