Public Procurement Strategy
HK-unique ยท DH procurement ยท Stage C mandate
Stage C โ 23 March 2026โ
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 Complianceโ
| Action | Recommended Lead Time |
|---|---|
| Appoint LRP | 6โ12 months before deadline |
| Prepare technical dossier | 1โ3 months |
| Submit via MDIS | Allow 2โ6+ months for review (standard route) |
| Expedited route | Shorter โ use if reference-country approval exists |
Private Hospital Requirementsโ
Stage C applies only to DH public procurement. Many private hospitals independently require MDACS listing. Confirm requirements with specific private hospital customers.