Change Notification

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

change1

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

Class

Category 2 (RM)

Category 3 (RM)

A

50

30

B

500

30

C

1,000

 30

D

1,500

 30

 A medical device that contains a medicinal product 

2,500

 30

 

Related Act and Regulations:

 

Related Guidance Documents:

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