Stage C — March 2026 Preparation Guide
HK-unique · Effective 23 March 2026 · DH public procurement
What Is Stage C?
From 23 March 2026, all applicable medical devices (AMDs) procured by the Department of Health must hold active MDACS listing. Announced 18 December 2025.
Affected Devices
- General medical devices: Class II, III, IV
- IVD medical devices: Class B, C, D
Compliance Checklist
| Action | Done? |
|---|---|
| Confirm device is an AMD | ☐ |
| Appoint or confirm LRP | ☐ |
| Compile technical dossier | ☐ |
| Submit MDACS listing via MDIS | ☐ |
| Receive HKMD number before 23 March 2026 | ☐ |
Timeline Recommendations
Standard route Class III/IV reviews typically take 3–6+ months from MDIS submission. Submit well in advance of the 23 March 2026 deadline. Expedited reliance pathways may be available if you hold reference-country approvals (CE, FDA, TGA, PMDA).
Note: AMD refers to Applicable Medical Devices — those subject to MDACS listing under Stage C (Class II, III, IV general devices and Class B, C, D IVDs).