Malaysia rejects pending applications exceeding 6 months and releases clarification on export device

Malaysia: MDA has released a recent announcement on the full enforcement of the need to register medical devices under section 5 of the Medical Device Act 2012 ( Act 737), as well as clarifications on export devices.

ARQon has conducted a translation the announcement, for the translated version, please click here.

For more information on export devices, check out the following links:

-Circular Letter No. 2 Year 2016 (Revision 1)

-Circular Letter No. 4 Year 2018 (Revision 1)

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