Two guidance documents, aimed at supporting medical device manufacturers and Authorized Representatives comply with the Medical Device Act (Act 737) and the regulations under it, were released by the Medical Device Authority of Malaysia (MDA) last November 2018:

1. The third edition of the “Requirements For Labelling Of Medical Devices ” provides guidance on the content of medical device labelling and applies to all products that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in-vitro diagnostic (IVD) Medical Devices, except for promotional materials and product brochures; whereas
2. The third edition of the “Change Notification For Registered Medical Device ” applies to all registered Medical Devices under the Act and provides guidance on what should the registration holder do in relation to each category of change to continue the importation, exportation or placement on the market of the medical device they are responsible for. Registered Medical Devices that undergo changes as a result of a mandatory reportable incident or field corrective action under Section 40 or Section 41 of Act 737 also fall under the scope of this guidance.