Technical References

Technical References

(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.)

Technical References for the Medical Device Administrative Control System are available in pdf format:

[TR-001] Principles of Conformity Assessment for Medical Devices
PDF
[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
PDF
[TR-003] Classification of General Medical Devices
PDF
[TR-004] Essential Principles of Safety and Performance of Medical Devices
PDF
[TR-005] Additional Medical Device Labelling Requirements
PDF
[TR-006] Classification of In Vitro Diagnostic Medical Devices (IVDMDs)
PDF
[TR-007] Software Medical Devices and Cybersecurity
PDF
[TR-008] Artificial Intelligence Medical Devices (AI-MD)
PDF