A doctor fills out medical forms indoors, focusing on patient care and documentation.

Can Foreign Manufacturers Sell Medical Devices in Malaysia? Market Entry & Local Authorised Representative Guide

Entering the Malaysian healthcare market can be a complex process for foreign medical device manufacturers. Selling medical devices in Malaysia is strictly regulated by the Medical Device Act 2012 (Act 737), enforced by the Medical Device Authority (MDA).   The regulations are designed to ensure that only safe and high-quality medical devices are available to …

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