On May 6, 2024, MDA released a circular letter in accordance with the decision made in the MDA Member Meeting No. 1/2024, the policy establishing the registration processes for medical equipment subject to trade restrictions that are imported or exported from nations without diplomatic ties to Malaysia has been authorized and is effective from April 26, 2024.
The procedure for registering medical devices imported from or exported to countries without diplomatic relations subject to trade restrictions by Malaysia must adhere to the following rules:
- As stated in the Customs Order (Prohibition on Import) and the Customs Order (Prohibition on Export), the establishment must first receive approval from the appropriate agency in order to obtain an import license or export license (approved permit - AP). A further requirement for medical device registration with the MDA will be ownership of the AP.
- Then, in compliance with Act 737's requirements, the establishment may submit an application to the MDA for medical device registration.
The MDA may consider an application for medical device registration if the establishment complies with both requirements (a) and (b) above. With the publication of Circular No. 1/2024, Circular No. 4/2014 (Revision 1) is no longer valid.
Staying up-to-date with the evolving regulatory framework is crucial. We strongly advise consulting official sources and seeking assistance from certified experts to guarantee complete adherence to the revised regulations.
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