custom_madeeee_1

  Legal/Guidance Documents/Announcement:

 A. Medical Device (Exemption) Order 2024

 B. MDA/GD/0064 – Custom-Made Medical Device Exemption Application

 C. Previous Announcement

 

How to Submit Application :

1. Application form : Medcast

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

3. Administrative Fee : RM 300

4. Application Process flow :  Flowchart

 

Reference Documents:

1. Essential Requirement: Medcast form

2. Template for statement of custom-made medical device: Annex B

3. Decision tree to classify custom-made medical device : Annex C

4. Healthcare’s Written Prescription : HCP Template

 

Contact Information:

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

 Officers in Charge :

  • En. Mohamad Naquib | ☎ +603-8230 0209 

 

Importance Notice :

  1. Please be informed that under the Medical Device (Exemption) Order 2024, custom-made medical devices are exempted from medical device registration. However, the exemption from establishment licensing only applies to a person who imports or exports the exempted medical device.

  2. All manufacturers of custom-made medical devices are required to be certified to ISO 13485.

 

  Updated : 7th September 2026