Regulatory Affairs Update: Malaysia

Malaysia: Establishment License Information By The Malaysian MDA

On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia posted an announcement regarding Establishment License Information.

Per Section 15 (1) of the Medical Device Act (Act 737), it was stated that no establishment shall import, export, or place in the market any registered medical device unless it holds an establishment license granted under this Act. The following stakeholders shall be aware of this announcement:

  • A manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include retailer; and
  • An authorized representative (AR) is appointed by a manufacturer with a principal place of business outside Malaysia.

The following are the key points of the announcement:

  1. Access to related guidance documents such as Licensing for Establishment, GDPMD, and Change of Ownership for Medical Device Registration.
  2. Access to a guideline for applying for an Establishment License under the Medical Device Act 2012 (Act 737).
  3. Access to guidelines regarding How to Create a MedDC@st account.
  4. Overview of Establishment Licensing Framework.
  5. Overview of Establishment License Application (covering new application, renewal, major/minor amendment, change of ownership, withdrawal)
  6. Explanation of major amendment and minor amendment.
  7. Requirement on Good Distribution Practice of Medical Device (GDPMD).
  8. Information on the list of registered CAB (Conformity Assessment Body).
  9. License static published by the MDA.

Further information of this announcement can be accessed here.

If you have any queries about this draft guidance, please contact us at or click the button below.

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