Malaysia – Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia’s Medical Device Authority (MDA) has published draft guidance on importing products for re-export. The draft guidance follows the publication of the Medical Device Exemption Order 2019, which freed some importers from the need to register their products.

Typically, a company that imports a medical device into Malaysia needs to register the product under the Medical Device Act 2012. However, under the 2019 exemption order, that requirement does not apply to companies that bring medical devices into Malaysia with the sole purpose of exporting them to another country…