CORONAVIRUS DISEASE (COVID-19): SPECIAL ACCESS
Coronavirus Disease (COVID-19): Special Access
Based on the current data of exempted medical devices from registration requirement through notification of Special Access (Route A), MDA will no longer consider Special Access notification through Route A. However, any person who wishes to request for exemption from registration requirement through Special Access Notification for medical devices will need to go through Route B and all particulars requested in the form shall be provided. The rationale of the notification must meet the criteria as specified under Section D of the form. This requirement is stated in the Medical Device Guidance Document on Notification of Medical Device for Special Access (MDA/GD/0043). Failing to meet the criteria will result in an unapproved notification.
Please note that only product classified as a medical device is eligible for Special Access Notification. Non-medical devices are not subjected to any approval or exemption from the Medical Device Authority (MDA) prior to supply. For medical device classification for PPE, please refer to the announcement in the MDA portal through this provided link: https://www.mda.gov.my/announcement/544-maklumat-tambahan-mengenai-peralatan-perlindungan-diri-personal-protective-equipment-ppe.html.