The Medical Device Authority of Malaysia (MDA) has issued Circular Letter No. 1 of 2024 titled “Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions.”
In accordance with the implementation of Circular Letter No. 1/2024, the procedure for registering medical devices imported from or exported to countries with no diplomatic relations, subject to trade restrictions by Malaysia, must adhere to the following guidelines:
- As delineated in the Customs Order (Prohibition on Import) and the Customs Order (Prohibition on Export), establishments must obtain prior approval from the relevant agency to acquire an import or export license (approved permit – AP). Ownership of the AP will serve as an additional criterion for medical device registration with the MDA; and
- Subsequently, establishments may proceed to apply for medical device registration with the MDA in accordance with the requirements of Act 737.
MDA will consider applications for medical device registration only if establishments comply with both requirements (a) and (b) as outlined above.
With the publication of Circular No. 1/2024, then Circular No. 4/2014 (Revision 1) is void.
Circular Letter No. 1/2024 can be accessed here.
This circular letter will be effective immediately according to the date the of the issuance of Circular Letter No. 1/2024.
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