Guidance Documents Overview
Technical References (TR) — Normative
Technical References (TR) — Normative
TRs define technical requirements and are binding for MDACS compliance. Always use the current version.
Document Topic TR-001 Essential Principles and general device requirements TR-002 Conformity Assessment pathways and acceptable evidence TR-003 Classification rules for general medical devices (Class I–IV) TR-004 Classification rules for in vitro diagnostic devices (Class A–D) TR-005 Adverse event and incident reporting procedures TR-006 Field Safety Corrective Actions (FSCAs) and notifications TR-007 Labelling, instructions for use (IFU), and user information TR-008 Clinical evidence requirements by device class and type
Guidance Notes (GN) — Procedural
| Document | Topic |
|---|---|
| GN-01 (2024) | MDACS Overview |
MDIS User Guides
Operational guides for the MDIS online submission portal — available from the MDD website.
Official Source
All documents: MDD Official Website → Department of Health → Medical Device Division
TRs and GNs are periodically updated. Download fresh copies before each submission.
Last Updated' column with note: 'All TRs and GNs include publication/revision dates. Download only the current version from the MDD website (https://www.drugoffice.gov.hk/english/infopage/mdm/201601/md_ref.html). Verify version numbers before submission.