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MALAYSIA: MDA Issue New Guidance Document on Importation of Medical Device for Re-Export (IRE) – May/June 2025

MALAYSIA: MDA Issue New Guidance Document on Importation of Medical Device for Re-Export (IRE) – May/June 2025

  • 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

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MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July/Aug 2024

MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July/Aug 2024

  • 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.

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