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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€‹

ActionRecommended Lead Time
Appoint LRP6โ€“12 months before deadline
Prepare technical dossier1โ€“3 months
Submit via MDISAllow 2โ€“6+ months for review (standard route)
Expedited routeShorter 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.