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. Notification form : Medcast

2. How to create Medcast AccountMedcast – Notification Creation

3. Administrative Charge : RM 300 

4. Post handling : Disposal of medical device for special access Form

5. Guidance Documents :   Special Access – Notification – General Requirements. "Document under revision"

6. Any inquiries, Please email to  [email protected]

7. Contact No. relevant Officer

    • Puan Haidar Nadirah Bt Hawalig +603-8230 0250
    • Puan Nur Maizura Bt Zarmani +603-8230 0339
    • Puan Aidahwaty Bt Ariffin +603-8230 0341 
    • En. Haqim (Printing Officer) +603-8230 0247  

 

Process flow:

 Special_Access_Flow_Chart.jpeg

 

Importance Notice :

  1. To be eligible for Special Access Notification, a valid establishment license is mandatory for all applicants. This condition is in accordance with the Medical Devices (Exemptions) Order 2024.

  1. 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: 15 February 2024