MedDeviceGuideMedDeviceGuide
Market

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.

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.

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.

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.

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.

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.