How Classification Works
Hong Kong classifies medical devices using an IMDRF-aligned risk-based system. Classification determines MDACS listing eligibility and documentation requirements.
Two Classification Systems
| Device Type | Technical Reference | Classes |
|---|---|---|
| General medical devices | TR-003 | Class I, II, III, IV |
| IVD medical devices | TR-004 | Class A, B, C, D |
General Classification Factors (TR-003)
Classification rules are based on:
- Intended purpose — what the device is designed to do
- Invasiveness — whether/how the device enters the body
- Duration of contact — transient (< 60 min), short-term, or long-term (>30 days)
- Active or non-active — whether energy is required
- Anatomical location — devices near CNS or heart carry higher risk
Risk Classes & MDACS Eligibility
| Class | Risk | MDACS Eligible |
|---|---|---|
| I | Low | ❌ No |
| II | Moderate-low | ✅ Yes |
| III | Moderate-high | ✅ Yes |
| IV | High | ✅ Yes |
| IVD A | Low | ❌ No |
| IVD B/C/D | Moderate–High | ✅ Yes |
Classification Process
- Define the intended purpose from the manufacturer's perspective
- Apply classification rules from TR-003 or TR-004
- If multiple rules apply, take the highest resulting class
- Document the classification rationale in your dossier