Public Procurement Strategy
HK-unique · DH procurement · Stage C mandate
Stage C — 23 March 2026
All applicable medical devices (AMDs) procured by the DH must have active MDACS listing from 23 March 2026:
- General: Class II, III, IV
- IVD: Class B, C, D
Timeline for Compliance
| Action | Recommended Lead Time |
|---|---|
| Appoint LRP | 6–12 months before deadline |
| Prepare technical dossier | 1–3 months |
| Submit via MDIS | Allow 2–6+ months for review (standard route) |
| Expedited route | Shorter — use if reference-country approval exists |
Private Hospital Requirements
Stage C applies only to DH public procurement. Many private hospitals independently require MDACS listing. Confirm requirements with specific private hospital customers.
AMDs refers to medical devices on the DH procurement framework that fall within the mandated classes (Class II, III, IV for general devices; Class B, C, D for IVDs). Devices used only for research, training, or non-clinical purposes are typically excluded. Confirm device eligibility with the DH procurement team.