The MDA has informed the public that they will give transition period until 31 December 2022 to the establishment for compliance with the requirements set out in the guidance document “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition”.
To ensure that the importation and distribution of medical device could be carried out smoothly, the establishment is advised to make preparation before 31 December 2022. Starting 01 January 2023, all establishment wishing to import and distribute medical devices to the Malaysian market must meet the labelling requirements stated in “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition“.
If you have any queries regarding the announcement on Medical Device labelling in Malaysia, please get in touch.