🇭🇰Hong Kong Medical Device Regulations

Issued Documents under MDACS

Collection of official documents, circulars, and announcements issued under the Medical Device Administrative Control System.

Guidance Notes for Medical Devices

Collection of guidance notes covering listing procedures, classification, and technical requirements for medical devices under MDACS.

Technical Reference 003 - Medical Device Classification

Technical Reference document for medical device classification. Hong Kong uses GHTF-aligned classification (Class A, B, C, D) based on intended use and risk level.

Medical Device Administrative Control System - Listing Application

MDACS is a voluntary listing system for medical devices. Devices must have valid marketing approval from a recognized reference regulatory authority (US FDA, EU, Japan, etc.).

Recognized Reference Regulatory Authorities

List of recognized reference regulatory authorities including US FDA, EU (CE Mark), Health Canada, TGA Australia, and PMDA Japan. Prior approval from one of these is required for MDACS listing.

Medical Device Division - Department of Health

The Medical Device Division (MDD) under the Department of Health regulates medical devices in Hong Kong through the Medical Device Administrative Control System (MDACS).