Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023.
This guidance document specifies requirements and notification process for the applicant to obtain permission from the Authority prior to the importation and/or placing of custom-made medical devices in the market.”
To view the guideline, please refer to: https://portal.mda.gov.my/doclink/notification-of-custom-made-medical-device-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJub3RpZmljYXRpb24tb2YtY3VzdG9tLW1hZGUtbWVkaWNhbC1kZXZpY2UtcGRmIiwiaWF0IjoxNjc3NjQ0Nzc0LCJleHAiOjE2Nzc3MzExNzR9.z_40MQIFtE_l_rKFt3XjY5yDmuq0d_U17_VtahVWmdo