On January 22, 2025, the Medical Device Authority (MDA) of Malaysia released a draft guidance document for the second edition of Importation of Medical Device for Personal Use (MDA/GD/0066). This document outlines the procedures for individuals seeking to import unregistered medical devices into Malaysia for personal use. Applicants may request a confirmation letter from the MDA regarding the personal use status of a medical device.
Key Highlights
The primary updates in this draft guidance document are outlined as follows:
- Confirmation Letter Requests:
- Individuals may request a confirmation letter from the MDA by completing the form found in Annex C, Importation of Personal Use Medical Devices Declaration Form, included in the guidance document.
- Applications should be submitted via email to exemption.bhai@mda.gov.my.
- Changes to Requirements:
- The requirement stating, “No same or similar medical device(s) is/are registered in Malaysia”, has been removed.
- The statement, “The importation of medical devices for the purpose of personal use is also exempted from the requirements of import permit under Customs (Prohibitions of Imports) Order 2023”, has been withdrawn.
Open to Public Feedback and Comments
This draft guidance document is open for public comment and feedback. Stakeholders are encouraged to share their input by submitting the public comment form via email to: The deadline for submitting comments is February 3, 2025.
The public comment form can be accessed here:
[Attachment 2 – Public Comment Form for the Development of GD Importation of Medical Devices for Personal Use – Updated 2025]
The public comment form can be accessed here:
[Attachment 2 – Public Comment Form for the Development of GD Importation of Medical Devices for Personal Use – Updated 2025]
Additional Resources
- Official announcement from the MDA MDA can be found here: https://portal.mda.gov.my/index.php/announcement/1504-public-comment-second-edition-guidance-document-importation-of-medical-device-for-personal-use
- Further information on the draft guidance can be found here: [‘Attachment 1 – Draft Guidance Document Importation of Medical Device for Personal Use 2nd Edition’]
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