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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 COVID-19 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
Other Documents
Listing Application
Medical Device Listing Application
Medical Device Trader Listing Application
Application for Conformity Assessment Body Recognition
Other Applications
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
Special Alerts
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
Safety 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
Briefing Seminar
Healthcare Professionals
Video
Useful Information
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Issued Documents under Medical Device Administrative Control System (MDACS)
Forms
Forms (Medical Devices Procured by the Hospital Authority)
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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 COVID-19 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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is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term statutory regulatory framework for medical devices.
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