Malaysia: Draft Regulation for Public Comments: Importation of Medical Device for Re-Export

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows:

1. Scope: Applies to all products that fall within the definition of medical device, as defined in MDA/GD/0001: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. This document aims to outline the necessary requirements and notification procedures for applicants, such as established companies in Malaysia, licensed establishments, or forwarding agents seeking authorization from the Authority to import medical devices for re-export purposes such as maintenance, testing, sterilization, packaging, labelling, distribution hub or other purposes specified by the applicant and intends not to be placed in the Malaysian market.

2. Coverage: Requirements during pre-importation, requirements during post-importation, conditions on Import for Re-Export (IRE) approval letter, and annexes as follows:

  • Annex A (informative) – Notification Process: Process Flow on Notification of Import for Re-Export Medical Device.
  • Annex B (normative) – Notification of Import for Re-Export Medical Device Form.
  • Annex C (normative) – Declaration in Import for Re-Export Template.
  • Annex D (normative) – Subsequent Notification of Import for Re-Export Medical Device.

Submission of Public Comment: Industries and stakeholders may submit their insights on this guidance document before 08 September 2023. Feedback can be submitted to anissuhaila@mda.gov using this form. 

This announcement can be accessed here.

For further information on the draft guidance document, please refer to this link.

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