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Change Notification

For any enquiries, kindly contact Registration Unit:

  • Email:
  • Phone Number: Registration Unit +603 8230 0376 or Pn. Aidahwaty bt Ariffin +603 8230 0341

Please be informed that email is permanently closed.

Changes in medical devices may take place from time to time as part of their life-cycle. Any change to a registered medical device is linked to the principles of safety and performance and the ability of the regulatory framework to manage the risk of the medical devices.

Before making any decision whether a changed medical device can continue to be placed in the market, the Authority will determine whether evidence of safety and performance have been appropriately collected and reviewed based on the notification made by the registration holder.

For any anticipated change to a medical device, a manufacturer must consider the impact of the change on the patient, practitioner and/or user of the medical device, and the impact of the change on the specifications of the medical device, and decide whether the change is expected to impact the safety and performance of the medical device.

Categories of changes

Category 1 changes of medical devices that affect their safety and performance and require new registration of the medical device

Category 2 changes are changes that require evaluation and endorsement from the MDA prior to implementation of the change and before placing in the market

Category 3 changes may be implemented immediately.

Overview of Change Notification


For further information, refer Change Notification for Registered Medical Device

Information on Fee Structure

As prescribe in the guidance document; the  fee is imposed as follows; 

Change Notification Fee


Category 2 (RM)

Category 3 (RM)













 A medical device that contains a medicinal product 




Related Act and Regulations:


Related Guidance Documents:



Updated: 20th July 2022


  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 

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  • Last Updated: 01 December 2023.
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Ministry of Health Malaysia
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