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Medical Device Division
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Recent Updates
Press Release
Events
MDACS Activities
Department of Health to implement a new strategy on procurement of medical devices
Information and Publication
Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area
Listed Rapid Antigen Tests for Influenza under MDACS
Public Education on Rapid Antigen Tests for COVID-19
Safety Alerts & Special Alerts related to COVID-19 Medical Devices (Starting from 1 January 2022)
Traders' Corner: Application for Listing of Rapid Antigen Test under MDACS
Others
Medical Device Administrative Control System
Scope
Implementation Progress
Issued Documents
Guidance Notes
Technical References
Code of Practice
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Listing Application
Medical Device Listing Application
Medical Device Trader Listing Application
Application for Conformity Assessment Body Recognition
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Examples of Medical Devices Classification
Examples of General Medical Devices Classification
Examples of In Vitro Diagnostic Medical Device Classification
Medical Device Information System
Online Tools
Is Your Product A Medical Device?
General Medical Device Classification Program
In Vitro Diagnostic Medical Device Classification Program
Report Medical Device Adverse Events
Application for Inclusion into Mailing List
Search Database
Asian Medical Device Nomenclature System (AMDNS)
The List of Medical Devices
Thematic Medical Devices
The List of Local Responsible Person (LRP)
The List of Importers
The List of Distributors
The List of Local Manufacturers
The List of Conformity Assessment Bodies (CAB)
Safety Alerts and Communications
Safety Alerts & Special Alerts
Medical Device Listed Under MDACS
Safety Alerts
Special Alerts
Medical Device NOT Listed Under MDACS
Safety Alert Summary
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Safety Alerts & Special Alerts related to Selected Medical Devices (Starting from 1 January 2022)
COVID-19 Medical Devices
Blood Glucose Meters and Test Strips
Male Condoms
Archive
Medical Device Listed Under MDACS
Medical Device NOT Listed Under MDACS
Safety Alerts (before 1 January 2022)
Press Release
Letters to Healthcare Professionals
Disciplinary actions under Medical Device Administrative Control System (MDACS)
List of Local Responsible Persons with Warning Letter Issued
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List of Medical Devices Delisted from the MDACS
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Briefing Webinar
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About Us
Medical Device Division
Contact Us
What's New
Recent Updates
Press Release
Events
MDACS Activities
Department of Health to implement a new strategy on procurement of medical devices
Information and Publication
Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area
Listed Rapid Antigen Tests for Influenza under MDACS
Others
Medical Device Administrative Control System
Scope
Implementation Progress
Issued Documents
Listing Application
Examples of Medical Devices Classification
Medical Device Information System
Online Tools
Report Medical Device Adverse Events
Application for Inclusion into Mailing List
Search Database
Safety Alerts and Communications
Safety Alerts & Special Alerts
Press Release
Letters to Healthcare Professionals
Disciplinary actions under Medical Device Administrative Control System (MDACS)
List of Local Responsible Persons with Warning Letter Issued
List of Traders Suspended from Listing under MDACS
List of Traders Delisted from the MDACS
List of Medical Devices Suspended from Listing under MDACS
List of Medical Devices Delisted from the MDACS
Information, Video and Publication
Thematic Pages
General Public
Traders
Healthcare Professionals
Video
Useful Information
Frequently Asked Questions
Issued Documents under Medical Device Administrative Control System (MDACS)
Forms
Forms (Medical Devices Procured by the Hospital Authority)
Useful Sites
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What's New
Recent Updates
Recent Updates
Press Release
Events
MDACS Activities
Department of Health to implement a new strategy on procurement of medical devices
Information and Publication
Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area
Listed Rapid Antigen Tests for Influenza under MDACS
Expand / Collapse
Public Education on Rapid Antigen Tests for COVID-19
Safety Alerts & Special Alerts related to COVID-19 Medical Devices (Starting from 1 January 2022)
Traders' Corner: Application for Listing of Rapid Antigen Test under MDACS
Others
Recent Updates
Recent Updates
(Display the records of last 12 months only)
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Press Release
Events
MDACS Activities
New Procurement Requirement of Medical Devices by DH
Information and Publication
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Caption: List Table
Posting Date
Title
09 May 2025
09 May 2025
MDACS Activities
Technical Reference “Personalised Medical Devices” (TR-009) has been issued
09 May 2025
09 May 2025
MDACS Activities
Guidance Notes “Definitions and Abbreviations for the Medical Device Administrative Control System” (GN-00) and “Overview of the Medical Device Administrative Control System” (GN-01) have been updated
17 Apr 2025
17 Apr 2025
MDACS Activities
The Department of Health co-organised with the CUHK Hong Kong-Shenzhen Innovation and Technology Institute (Futian) for a briefing seminar on the Medical Device Administrative Control System (MDACS)
17 Apr 2025
17 Apr 2025
Others
Delegates from the Department of Health met with representative from the Vanke School of Public Health, Tsinghua University to have an in-depth exchange on the regulatory regime of Chinese medicine, drugs and medical devices
08 Apr 2025
08 Apr 2025
MDACS Activities
The webpage on “Listed Male Condoms under MDACS” has been updated
01 Apr 2025
01 Apr 2025
Others
Secretary for Health meets Deputy Commissioner of National Medical Products Administration
06 Mar 2025
06 Mar 2025
MDACS Activities
The webpage on “Listed Rapid Antigen Tests for Influenza under MDACS” has been updated
04 Mar 2025
04 Mar 2025
MDACS Activities
The webpage on “Listed Rapid Antigen Tests for Influenza under MDACS” has been updated
24 Feb 2025
24 Feb 2025
MDACS Activities
The webpage on “Listed Rapid Antigen Tests for Influenza under MDACS” has been updated
12 Feb 2025
12 Feb 2025
MDACS Activities
The “Listed Rapid Antigen Tests for Influenza under MDACS” have been posted to the website
05 Feb 2025
05 Feb 2025
Events
Introduction of Medical Device Administrative Control System (MDACS) (Briefing Webinar) (Putonghua)
21 Jan 2025
21 Jan 2025
Others
Chinese name of the Medical Device Division has been renamed
20 Jan 2025
20 Jan 2025
MDACS Activities
The webpage on “Listed Rapid Antigen Tests for COVID-19 under MDACS” has been updated
17 Dec 2024
17 Dec 2024
Others
Delegates from the Department of Health attend the 28th Global Harmonization Working Party (GHWP) annual meeting
04 Dec 2024
04 Dec 2024
Others
Secretary for Health meets Vice-minister of National Health Commission in Beijing
04 Dec 2024
04 Dec 2024
Events
Introduction of Medical Device Information System (MDIS) (Online Briefing Seminar) (Cantonese)
15 Nov 2024
15 Nov 2024
MDACS Activities
Delegates from the Department of Health attend Governance of Medical AI Conference held by HKU Centre for Medical Ethics and Law
15 Nov 2024
15 Nov 2024
MDACS Activities
Various Technical References have been updated
04 Nov 2024
04 Nov 2024
Events
Briefing for Updates of Guidance Notes on Adverse Event Reporting by Local Responsible Persons under the Medical Device Administrative Control System (MDACS) (Cantonese)
30 Sep 2024
30 Sep 2024
MDACS Activities
New arrangement of Processing of Renewal Application of Listed Medical Device
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Press Release
Events
MDACS Activities
Information and Publication
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