8th November, 2017

On October 9, 2017, Medical Device Authority (MDA) Malaysia released a Second Edition of the Guidance Document on Change Notification for Registered Medical Device. This GD serves a great purpose in informing the stakeholders on the categories of changes, notification process and relevant requirements for applying for a change notification in Malaysia.

The differences noticed in this Second Edition are as following:

$1         i.            The Change Notification Turn-around-Time mentioned in the 1st Edition has been removed in the 2nd edition. This means the waiting period for a Change Notification application to get approved is no longer fixed and manufacturers will have to be patient with the delay caused by various factors.

$1       ii.            In Change of Notification for Category 2, all the changes do not require to be reported and get Endorsement Letter from MDA first. The applicant can directly submit the other required documents to MDA to process the changes.

Before this, before submitting relevant documents to the MDA to process the Change Notification, MDA needs to be informed first and manufacturer or AR will receive an Endorsement Letter which approves for them to proceed further. Henceforth, that first step has been removed and manufacturers or ARs can directly start the Change Notification application procedure by submitting relevant documents online to the MeDCaSt portal.

References:

Guidance Document on Change Notification for Registered Medical Device (2^nd Ed.)