Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use

The Medical Device Authority (MDA) of Malaysia has released Guidance Document MDA/GD/0066, First Edition, titled “Importation of Medical Device for Personal Use”, to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its associated regulations.

This guidance serves as a comprehensive resource for individuals intending to import medical devices into Malaysia for personal use. This newly issued regulation roughly consists of the following information:

  • That medical devices for personal use have been exempted from the requirements for registration of medical devices as mentioned under Section 5 of Act 737;
  • A person who imports medical devices for personal use is exempted from the requirements of an establishment license under Section 15 of Act 737;
  • Requirements for importing or purchasing medical devices for personal use;
  • Requirement for the request of issuance of the Letter of Confirmation that the imported medical devices have fulfilled the definition and criteria of personal use.

Further information on this regulation can be accessed here IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE (

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