On December 18, 2025, the Hong Kong Department of Health (DH) officially announced the implementation date for Phase 2 – Stage 2 (Stage C) of its enhanced Medical Device (MD) Procurement Strategy.
Scope
Implementation of Phase 2 – Stage 2 (Stage C) of the DH Medical Device Procurement Strategy, introducing mandatory requirements that all medical devices procured by DH must be listed under MDACS, from March 23, 2026.
Background
Since June 21, 2023, DH has been enhancing its MD Procurement Strategy through a two-phase approach:
- Phase 1 commenced on June 21, 2023
- Phase 2 – Stage 1 (Stage B) commenced on November 1, 2024
During the Q3 2025 LRP Panel Meeting, the Medical Device Division (MDD) indicated that Phase 2 – Stage 2 (Stage C) would tentatively commence in early 2026.
DH has now confirmed that Phase 2 – Stage 2 (Stage C) will take effect on March 23, 2026.
Key Points
- From March 23, 2026, all medical devices procured by DH must be listed under MDACS.
- This requirement applies to procurement through both quotation and tender mechanisms.
- DH anticipates a significant increase in MDACS listing applications and strongly encourages suppliers planning to bid for DH-funded services to submit listing applications as early as possible to ensure eligibility.
Procurement Requirements by Phase
| DH Scheme for applicable MDs* | Phase 1 From 21 Jun 2023 |
Phase 2 – Stage 1 From 01 Nov 2024 |
Phase 2 – Stage 2 (Stage C) From 23 Mar 2026 |
|
|---|---|---|---|---|
| Quotation | Preference to Listed MDs | ✓ | ✓ | |
| Listed MD or have submitted application for listing | ✓ | |||
| Must be Listed MDs | ✓ | |||
| Tender | Preference to Listed MDs | ✓ | ✓ | |
| Technical score to Listed MDs | ✓ | ✓ | ||
| Must be Listed MDs | ✓ | |||
#Applicability
The MDACS listing requirement applies to:
- Class II–IV General Medical Devices (GMDs)
- Class B–D In Vitro Diagnostic Medical Devices (IVDMDs)
(as defined under MDACS classification rules)
Implications to Clients
If your medical device is not yet listed under MDACS, immediate action is strongly recommended. Medical devices that are not MDACS listed by March 23, 2026 will no longer be eligible for DH procurement through either quotation or tender. Early submission is advised to mitigate regulatory and commercial risks associated with anticipated application backlogs.
Next Steps
If you require assistance with MDACS listing applications, our regulatory team can support you throughout the process.
Contact us at info@nordpacificmed.com or click the button below for more details.