Malaysia: Revision of Requirements for Labelling of Medical Devices

In October 2021, the MDA updated the guidance document on medical devices labeling (MDA/GD/0026).

Listed are the changes made in this fourth edition:

1. For the labelling of registration number on medical devices, use of the QR code is encouraged. This QR code can be found in medical device registration certificate.

2. Customers and users shall be able to access medical device registration number, manufacturer/authorized representative (AR) information and the QR code on the labelling.

3. Location of translation into Bahasa Malaysia shall be either next to the English version, or the location has to be decided through a risk assessment exercise.

4. Any decommissioning or disposal information (infection or microbial hazards, environmental hazards, physical hazards) must be included in the labelling

5. Information under the new section about electronic labelling includes:

• Electronic IFU (e-IFU) is only eligible for devices meant for professional use.

• e-IFU is optional for home use devices, however paper-form IFU is compulsory

6. Use MDA’s name or logo is strictly prohibited in any labelling on devices, as that would imply endorsement by MDA.

Sources:

MDA/GD/0026: Guidance Document on Requirements for Labelling of Medical Devices

Contact us at info@arqon.com for more info