Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for Labeling of Medical Devices" and "Change Notification of Registered Medical Devices".
The purpose of medical device labeling is to communicate safety and performance-related information to users and/or patients as well as to identify the device. Also, this guidance is intended to provide guidance to manufacturers and authorised representatives on the content of medical device labelling.
This guidance applies to all products that fall within the definition of medical device, as defined in Section 2 of ACT 737 and MDA/GD/0006, Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. Promotional materials and product brochures are excluded from the scope of this document.
The objectives of this guidance are to define the types of changes in relation to registered medical devices and to specify the requirements to continue importing, exporting, or placing the medical devices on the market.
This guidance applies to all registered medical devices under the Act and it sets out points for consideration by the registration holder when a registered medical device is in the process of change or modification.