Traders
(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)
Briefing Seminar
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)