Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device Authority (MDA) according to Section 5(1) of Act 737. However, there are no specific prohibitions for the registration of medical devices imported from/exported to countries that do not have diplomatic relations with Malaysia or that are subjected to trade restrictions. Establishments only obey the policies the Royal Malaysian Customs Department imposes and any latest policies issued occasionally.
Hence, effectively from 26 April 2024, MDA Board Meeting No.1/2024 has approved one registration procedure flow for medical devices imported from/exported to countries without diplomatic relations that are subjected to trade restrictions, automatically revoking the previous circular letter of the MDA No.4/2014 (Revision 1).
Establishments must obtain an Approved Permit – AP from the relevant agency, as approval for the import/export license, as outlined in the Customs (Prohibition of Imports) Order and Customs (Prohibition of Exports) Order. AP Possession will be an additional criterion for medical device registration with MDA; and
Establishments may proceed to apply for medical device registration with MDA under the provisions of ACT 737.
If both of the above requirements are met, MDA may consider the medical device registration application.
Source: Medical Device Authority (MDA)
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