Hong Kong

Cisema Logo: Navigating Regulation, Empowering Innovation
Cisema Launches a Redesigned Website

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

May 6, 2026
Cisema Launches a Redesigned Website
GBA Connect Scheme: Using Real World Data to Support China NMPA Approval
GBA Connect Scheme: Using Real World Data to Support China NMPA Approval

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

April 23, 2026
GBA Connect Scheme: Using Real World Data to Support China NMPA Approval
Stock photo of a Chinese woman seated in a modern medical aesthetics clinic just seconds before receiving dermal filler treatment

Hong Kong Expands Medical Device Listing Scope for Injectable Dermal Fillers

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

May 29, 2026
Hong Kong Expands Medical Device Listing Scope for Injectable Dermal Fillers
Minimalist, well-lit medical aesthetics clinic in Hong Kong. An Asian female doctor in a simple white coat and disposable gloves sits beside a female patient, holding a single unbranded prefilled syringe at chest level.

Hong Kong Clarifies Classification of Injectable Products

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

May 13, 2026
Hong Kong Clarifies Classification of Injectable Products
A single Asian scientist in their 30s wearing a lab coat, safety glasses, and nitrile gloves seated at a tidy bench in a modern pharmaceutical laboratory in Hong Kong, calmly reviewing a few printed documents while referencing a simple laptop screen

Hong Kong Launches Primary Evaluation Phase 1 for NDAs

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

May 6, 2026
Hong Kong Launches Primary Evaluation Phase 1 for NDAs

Hong Kong to Regulate Medical Gases as Pharmaceutical Products from June 2026

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

April 23, 2026
Hong Kong to Regulate Medical Gases as Pharmaceutical Products from June 2026

Guangdong MPA Publishes 2025 GBA Connect Scheme Medical Products Catalogue

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

March 31, 2026
Guangdong MPA Publishes 2025 GBA Connect Scheme Medical Products Catalogue

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And discover how we can support you in getting your products certified for China.

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