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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 Bt Ariffin | ☎ +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