Overview of the Medical Device Division (MDD) and MDACS in Hong Kong

Introduction

The Medical Device Division (MDD), under the Department of Health of the Government of the Hong Kong Special Administrative Region, is the regulatory body responsible for overseeing the safety, quality, and performance of medical devices.

Medical Device Administrative Control System (MDACS)

The MDACS is a voluntary listing system currently in place to regulate medical devices. It includes:

• Listing of Devices: Registration of Class II, III, and IV general medical devices and Class B, C, and D in vitro diagnostic (IVD) devices.
• Traders Listing: Registration of importers, distributors, and local manufacturers.
• Local Responsible Person (LRP): A requirement for manufacturers outside Hong Kong to appoint a local representative to manage regulatory obligations.

Key Functions and Roles

1. Pre-market Control: Vetting applications for listing based on international standards (like ISO 13485).
2. Post-market Monitoring: Managing a system for reporting and investigating adverse incidents involving medical devices.
3. Information Search: Maintaining a public database for listed devices and traders to enhance transparency.
4. Procurement Standards: The Department of Health is gradually mandating that devices used in public facilities must be listed under MDACS (Stage C effective March 2026).

Greater Bay Area (GBA) Measure

A special measure allows designated healthcare institutions in the GBA to use medical devices used in Hong Kong public hospitals with urgent clinical use, facilitating cross-border healthcare integration.