Criteria :

1. Designed and manufactured according to a written prescription from a qualified medical practitioner for the sole use of a particular patient.

2. Does not fall into the category of mass-produced medical devices that require adaptation for specific professional user requirements.

 

** Medcast form requirement: - Crucial to adhere (click here) -

 

How to apply?

A. Notification form : Medcast

B.  How to create Medcast Account : Medcast – Notification Creation

C. Administrative Charge : RM 300

D. Guidance Documents : NOTIFICATION OF CUSTOM-MADE (MDA/GD/0064)

E. Any inquiries, please email to  [email protected] 

F. Contact No. relevant Officer:

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

Process flow:

 Custom-made_Flow_Chart.jpeg

 

 

Importance Notice :

  1. Kindly note that commencing 1 December 2023, all submissions for Custom Made Medical Device Notifications are required to be made through the MeDC@St 2.0 online platform. Any applications received via email at [email protected] after this date will not undergo processing.
  1. The Custom-Made Notification System is activated using earlier version of Medcast 2.0. Users may face system bugs, but rest assured, it won't impact your application's submission. Applicants are advised to refer the Medcast Form Requirement to prevent any potential issues. If you encounter unresolved issues, please reach out to the MDA officer for assistance.

 

Updated: 15 Feb 2024