Medical Device (Exemption) Order 2024 – Exemption Application

The Medical Device Authority (MDA) announces the enforcement of the Medical Device (Exemption) Order 2024, effective from 5 March 2024. This new order supersedes the 2016 exemption order and expands the scope for specific exemptions from the registration requirement under Section 5 of the Medical Device Act 2012 (Act 737).

Categories of Exemptions

  1. Personal Use: Medical devices brought into Malaysia for individual use only.
  2. Demonstration for Marketing: Non-clinical marketing activities such as exhibitions or symposia.
  3. Education: Devices used for non-promotional teaching or training purposes.
  4. Clinical Research: Systematic studies on devices for safety and effectiveness on human subjects.
  5. Performance Evaluation: Testing to verify performance of in vitro diagnostic devices.
  6. Export Only: Devices intended solely for export.
  7. Import for Re-Export: Devices imported for the purpose of re-export.
  8. Custom-Made Medical Devices: Specifically designed per medical prescriptions for individual patients.
  9. Special Access Medical Devices: Devices used in emergencies or when conventional treatment is unavailable.
  10. Orphaned, Obsolete, or Discontinued Devices: Devices no longer in active distribution or production but maintained in healthcare facilities.

Conditions and Application Requirements

Applications must be submitted either via the Medcast Online System or Google Form, with an administrative fee. For more details on the application process and required documents for specific categories of exemptions, please refer to the MDA Portal Industry - Exemption section.

Exemptions for personal use, orphaned, obsolete, or discontinued devices are subject to specific handling requirements as defined by the MDA.

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Updated : 1 Nov 2024