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Medical Device Listing Application – Useful Information

• Overview of Hong Kong Medical Device Listing Process
• Medical Device Listing Application – Useful Information
• Documents Essential to Medical Device Listing Application under MDACS

Briefing Webinar

• Briefing Webinar on the Listing Application of Medical Devices under Medical Device Administrative Control System (MDACS)

Reference Materials for Briefing Seminar

• Briefing for Updates of Guidance Notes on Adverse Event Reporting by Local Responsible Persons under the Medical Device Administrative Control System (MDACS) (Chinese Version Only)
• Introduction of Medical Device Administrative Control System (MDACS) (Chinese)
• Introduction of Medical Device Administrative Control System (MDACS) (English)
• Briefing for Guidance Notes on Changes for Listed Medical Devices (Chinese) (For reference only)
• Briefing for Guidance Notes on Changes for Listed Medical Devices (English) (For reference only)
• Briefing for Technical References on Software Medical Devices and Cybersecurity and Artificial Intelligence Medical Devices (AI-MD) (Chinese Version Only)

Training Materials on Medical Device Information System (MDIS)

• Part I: Account Registration
• Part II: Application for Listing
• Part III: Reporting of Medical Device Safety Alerts and Adverse Events

General Information

• Leaflet of Medical Device Administrative Control System (MDACS)
• What is a Medical Device?
• Is Your Product A Medical Device?
• General Medical Device Classification Program
• Classified Examples of General Medical Devices
• In Vitro Diagnostic Medical Device Classification Program
• Classified Examples of In Vitro Diagnostic Medical Devices
• Asian Medical Device Nomenclature System (AMDNS)

Others

• Video - Is Your Product a Medical Device?
• Video - What are the Factors Affecting the Risk Classes of General Medical Devices?
• Video - What are the Factors Affecting the Risk Classes of In Vitro Diagnostic Medical Devices?
• Video - How to complete an application for listing of Class II/III/IV General Medical Device? (Chinese Version Only)
• Video - How to complete an application for listing of Class B/C/D In-Vitro Diagnostic Medical Device? (Chinese Version Only)
• Video - The Roles and Responsibilities of Local Responsible Person (Chinese Version Only)
• Leaflet - Listing of Rapid Antigen Test for COVID-19 under Medical Device Administrative Control System (MDACS)
• Video - Application for Listing Rapid Antigen Tests for COVID-19 under Medical Device Administrative Control System (Chinese Version Only)