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Hong Kong

6 articles

Regulatory

Hong Kong MDD: 20 Local Responsible Persons Hold 44% of 13,049 Device Listings

13,049-record Hong Kong MDACS analysis: US-made devices lead at ~28%, the top 20 LRPs hold 44% of listings, and 2025 saw a record 4,981 listings before mandatory procurement rules.

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Regulatory

Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00

How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.

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Regulatory

Hong Kong Dermal Filler MDACS Listing Strategy: LRP, Docs, Importers, Procurement

Guide to listing injectable dermal fillers under Hong Kong MDACS after the May 2026 GN-00 update: LRP, technical dossier, importer controls, adverse event reporting, and procurement.

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Regulatory

Hong Kong MDACS GN-00 Update: Why Injectable Dermal Fillers Are Now Medical Devices

On 13 May 2026, Hong Kong MDD updated GN-00 to classify injectable dermal fillers as medical devices under MDACS. What changed, why it matters, and what manufacturers must do.

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Regulatory

Hong Kong Medical Device Registration Cost and LRP Pricing 2026

Compare Hong Kong MDACS registration and LRP pricing models, including flat fees, hourly billing, 3-year cash flow, government fee status, and transition planning.

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Regulatory

Hong Kong Medical Device Registration: MDACS and LRP Guide

Register medical devices in Hong Kong through MDACS, including LRP duties, classification, reference pathways, Stage C procurement rules, fees, timelines, and transition planning.

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