Guidance Documents Overview
Technical References (TR) — Normative
| Document | Topic |
|---|---|
| TR-001 | Essential Principles |
| TR-002 | Conformity Assessment |
| TR-003 | Classification — General Devices |
| TR-004 | Classification — IVDs |
| TR-005 | Adverse Event Reporting |
| TR-006 | FSCAs |
| TR-007 | Labelling |
| TR-008 | Clinical Evidence |
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
Always use current versions
TRs and GNs are periodically updated. Download fresh copies before each submission.