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Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064)

On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.   It also specifies the specific requirements and notification process to obtain permission from the authority prior to the importation and/or placing of custom-made medical devices in the market.

The following are the summary of the guidelines:

  1. The guideline contains six (6) requirements as follows:
    1. General requirements
    2. Requirements for the manufacturer
    3. Requirements for written prescription
    4. Requirement for Custom-made medical device statement
    5. Labelling Requirement
    6. Advertising Requirement
  2. Notification Process to the Authority
    1. Notification form together with the required information/documents as described in Annex A and Annex B to the Medical Device Authority (MDA) shall be submitted by email to cm@mda.gov.my.
    2. The administrative charge is RM 300.
    3. The turn-around time per application is 14 days upon submission of the complete form and supporting documents.

For further information on the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064), please refer to this link.

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