Malaysia: New Guidance on Change Notification For Registered Medical Devices

The Malaysian’s Medical Device Authority (MDA) has released a new guidance on change notification for medical devices that has already been registered. The new document specifies three categories of changes based on the extent to which the modification might affect the safety and performance of the device. The document explains what each category requires of manufacturers to notify the MDA of a change.

The guidance document does not describe every type of change that can occur, but it provides several examples of the types of modifications that might fall into each category.

This guidance applies also to situations when a registered medical device undergoes any changes or proposed changes as a result of a mandatory reportable incident or field corrective action under Malaysian law.

For the guidance please go to: MDA – Guidance documents.