Special Access Medical Device
Definition : Medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.
Essential Requirement: Adhere to this prior to submission -click here-
1. Guidance Documents : Special Access – Notification – General Requirements. "Document under revision"
2. Notification form : Medcast
3. How to create Medcast Account : Medcast – Notification Creation
4. Post handling : Disposal of medical device for special access Form
5. Any inquiries, Please email to sa.
6. Contact No. relevant Officer
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- Puan Nur Maizura Bt Zarmani +603-8230 0339
- Puan Aidahwaty Bt Ariffin +603-8230 0341
Process flow:
Importance Notice :
- Kindly note that commencing July 1, 2023, all submissions for Special Access Medical Device Notifications are required to be made through the MeDC@St 2.0 online platform. Any applications received via email at after this date will not undergo processing.
- Effective from September 1, 2023, strict adherence to the essential requirement is mandatory. Applications that do not align with these stipulations might face rejection. In the event of an application being returned, the designated time frame for resubmission is limited to 7 working days.
Updated: 8 September 2023
