Hong Kong
2 articles
Hong Kong Medical Device Registration Cost 2026: LRP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
Hong Kong medical device registration in 2026: USD 6,000–18,000 over 3 years for MD Class II / IVD B and USD 9,000–40,000 for Class III–IV / IVD C–D under voluntary MDACS — entirely LRP service fees, since government fees are zero. Pure Global flat fee from USD 2,000/year. Hourly, reg+annual, and flat-fee models compared with 3-year cash flow, switching playbook, and Medical Device Bill transition coverage.
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.