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Read Full Article →Learn how foreign medical device manufacturers can appoint multiple distributors in Malaysia, why independent license holding helps avoid distributor lock-in, and how an authorized representative (AR) supports MDA registration, importer coordination, and market expansion.
Learn the difference between an authorized representative (AR), importer and distributor for medical devices in Malaysia. Understand who registers medical devices with MDA, who imports, who distributes, and why foreign manufacturers should choose the right license holding structure.
Learn how foreign medical device manufacturers can register medical devices in Malaysia through MDA. Understand authorized representative requirements, Medical Device Centralised Online Application System (MeDC@St) submission, classification, documentation, conformity assessment, timelines, fees, and distributor strategy.
Learn what a Malaysia medical device authorized representative is, why foreign manufacturers need one, how the AR supports Medical Device Authority (MDA) registration in Malaysia, and how it differs from an importer or distributor.
Learn how foreign medical device manufacturers can appoint a Malaysia medical device license holder or authorized representative to support MDA registration, distributor appointment, market entry, and post-market compliance.
Talk to our regulatory experts and discover how DuoGate can accelerate your journey.
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