Hong Kong

Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.

The guideline introduces more detailed evidence requirements for Hong Kong and Macao drug imports while retaining a streamlined pathway for products already approved under the GBA Connect scheme.

The revised 2026 GBA Connect Scheme framework sets higher bars for clinical need while fast-tracking repeat approvals for imported medical devices.

Updated MDACS guidance creates a new pathway for qualifying technologies and outlines the evidence required for priority consideration.

The updated GN-00 guidance reduces classification uncertainty and creates clearer MDACS pathways for injectable dermal fillers in Hong Kong.

Hong Kong classifies classifcation of injectable products, impacting medical aesthetics and borderline products.

Hong Kong introduces Primary Evaluation Phase 1 for NDAs, requiring pathway selection across 3 routes and reshaping drug registration strategy.

Learn the registration requirements, scope, and compliance steps as Hong Kong regulates medical gases as pharmaceutical products.

Guangdong’s MPA and Health Commission issued the 2025 GBA Connect “urgently needed” catalogue covering 115 Hong Kong–Macao drugs and devices.