MDACS Technical References (TR Series)
HK-unique · TR series are the primary compliance reference
Technical References (TRs) are normative guidance documents published by the MDD that define the standards and requirements for device conformity assessment, classification, and post-market monitoring. TRs serve as the primary regulatory reference for MDACS compliance and are functionally equivalent to regulations in a statutory framework.
| Reference | Title |
|---|---|
| TR-001 | Essential Principles of Safety and Performance |
| TR-002 | Conformity Assessment |
| TR-003 | Classification of General Medical Devices |
| TR-004 | Classification of IVD Medical Devices |
| TR-005 | Adverse Event Reporting |
| TR-006 | Field Safety Corrective Actions |
| TR-007 | Labelling |
| TR-008 | Clinical Evidence |
Guidance Notes (GN Series)
| Reference | Title |
|---|---|
| GN-01 (2024) | Overview of MDACS |
All TRs and GNs are published on the MDD official website. Always use the current version.
Note: This list reflects the current published TR series as of the content review date. The MDD may issue additional Technical References or updates. Always verify against the official MDD website (www.mdd.gov.hk) for the most current versions and any newly published TRs.