Using Hong Kong Registered Drugs and Medical Devices in the Greater Bay Area: A Comprehensive Guide

The measure for using Hong Kong registered drugs and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) represents a significant step forward in regional healthcare integration and accessibility.

Background and Purpose

Initiative Overview

• Launched in November 2020
• Part of the Work Plan for Regulatory Innovation and Development
• Aims to facilitate healthcare services for Hong Kong residents in the GBA
• Enables access to urgently needed clinical treatments

Key Objectives

• Improve healthcare accessibility
• Enhance cross-border medical services
• Facilitate regulatory innovation
• Support regional healthcare development

Implementation Progress

Timeline

• January 2021: Trial implementation at HKU-Shenzhen Hospital
• August 2021: Extension to nine GBA cities
• February 2023: Second batch of designated hospitals
• September 2024: Third batch of designated hospitals

Current Status

• 45 designated healthcare institutions
• 51 approved drugs
• 63 approved medical devices
• Coverage across major GBA cities

Designated Healthcare Institutions

First Batch (2021)

• University of Hong Kong-Shenzhen Hospital
• Modern Hospital Guangzhou
• Guangzhou United Family Hospital
• C-MER (Zhuhai) Dennis Lam Eye Hospital
• Zhongshan Chenxinghai Hospital

Second Batch (2023)

• Additional hospitals across GBA cities
• Expanded coverage of medical services
• Enhanced accessibility for patients

Third Batch (2024)

• Further expansion of healthcare network
• Increased treatment options
• Broader geographical coverage

Application Process

For Drugs

1. Eligibility Requirements

   • Must be registered in Hong Kong
   • Must have urgent clinical use
   • Must meet safety standards

2. Application Steps

   • Submit application to GDMPA
   • Provide necessary documentation
   • Await approval process

For Medical Devices

1. Eligibility Criteria

   • Must be used in Hong Kong public hospitals
   • Must have urgent clinical need
   • Must meet safety requirements

2. Application Procedure

   • Complete application forms
   • Submit supporting documents
   • Follow review process

Benefits and Impact

For Patients

1. Improved Access

   • Faster availability of treatments
   • Access to innovative therapies
   • Enhanced healthcare options

2. Quality Care

   • Standardized medical services
   • Regulated product quality
   • Professional healthcare support

For Healthcare System

1. Integration Benefits

   • Cross-border healthcare coordination
   • Resource optimization
   • Enhanced service delivery

2. Development Opportunities

   • Regional healthcare advancement
   • Innovation promotion
   • Quality improvement

Future Developments

Ongoing Expansion

• More designated hospitals
• Additional approved products
• Enhanced regulatory framework

Continuous Improvement

• Process optimization
• Policy refinement
• Service enhancement

Latest Updates

Recent Developments

• Regular updates to approved product lists
• Expansion of designated hospitals
• Enhancement of application procedures

Important Notices

• Check latest approved products
• Verify designated hospitals
• Follow updated guidelines