Special Access Medical Device

Legal/Guidance Documents:

1.  Medical Device (Exemption) Order 2024
2.  MDA/GD/0043 – Special Access Exemption Application

How to Submit Application :

1. Application form :  Medcast
2. How to create Medcast Account : Medcast – Notification Creation
3. Administrative Fee : RM 300

Reference Documents:

1. Essential Requirement:  Medcast form
2. Medical Practitioner’s Request Letter :  Template
3. Post handling :  Disposal Form

Contact Information:

• General Email: [ sa.cm@mda.gov.my ]
• Admin : Mohamad Aznil  | ☎ +603-82300 0247

Officers in Charge :

• Pn. Nur Maizura Bt Zarmani | ☎ +603-8230 0339 
• Pn. Aidahwaty Ariffin @ M.Olaybal, A.M.N | ☎ +603-8230 0364 

Important Notice :

1.   Please be advised that applications that do not meet stated criteria or lack proper justification will be rejected.

2.   To qualify for Special Access Notification, all applicants must possess a valid establishment license, specifically as an Authorized Representative and Importer. 

Prepared by: Pre Market Control Division 

Uploaded by: Corporate Communication Division

Updated on: 11 May 2026