Technical References
(Note: The Chinese name of the Medical Device Division will be renamed with effect from 21 January 2025 while the English name remains unchanged. All issued listing certificates shall remain valid until their expiry date. For enquiry, please contact the Medical Device Division.)
Technical References for the Medical Device Administrative Control System are available in pdf format:
[TR-001] Principles of Conformity Assessment for Medical Devices
[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
[TR-003] Classification of General Medical Devices
[TR-004] Essential Principles of Safety and Performance of Medical Devices
[TR-005] Additional Medical Device Labelling Requirements
[TR-006] Classification of In Vitro Diagnostic Medical Devices (IVDMDs)
[TR-007] Software Medical Devices and Cybersecurity
[TR-008] Artificial Intelligence Medical Devices (AI-MD)
.gif
)
