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Regulatory

Hong Kong Medical Device Registration Guide: MDACS Listing, Local Responsible Person, and Transition Planning

Complete guide to registering medical devices in Hong Kong — MDACS voluntary listing process, LRP requirements, GHTF/IMDRF classification (Class I–IV, IVD Class A–D), reference country pathways, Stage C mandatory procurement rules effective March 2026, upcoming Centre for Medical Products Regulation, timeline, fees, and transition strategy.

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