Hong Kong vs Malaysia Medical Device Registration

Hong Kong vs Malaysia Medical Device Registration: Complete Comparison (2026)

Quick Answer Hong Kong uses a voluntary listing system (MDACS) with Class I–IV for general devices and Class A–D for IVDs, overseen by the Medical Device Division (MDD). Malaysia uses a mandatory registration system under the MDA and Act 737, with Class A–D classification for all devices. Both require a local representative — Hong Kong …

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