On September 5, 2025, the Department of Health (DH) shared key regulatory updates during the Quarterly LRP Panel Meeting. The discussions included the following key notes:
Key Notes
1. DH Medical Devices (MDs) Procurement Strategy – Phase 2 Update
Since June 21, 2023, DH has enhanced its MD Procurement Strategy through a two-phase approach. Phase 2 commenced on November 1, 2024, and is currently in Stage 1:
Stage 1
- Quotation: Applicable MDs are:
- Listed MDs under MDACS, or
- MDs with a listing application submitted and assigned an Application Number by the quotation closing time.
- Tender: Preference (technical score) will be given to MDs listed under MDACS.
Stage 2
- Tentatively scheduled to begin on January 1, 2026.
- Only MDACS-listed MDs will be eligible.
Note from MDD: Early listing is encouraged to ensure a smoother transition.
Summary Table Shared by MDD
| DH Scheme for applicable MDs* | Phase 1 From 21 Jun 2023 | Phase 2 – Stage 1 From 01 Nov 2024 | Phase – Stage 2 (tentative) 01 Jan 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 | ✓ | |||
*Applicable to Class II-IV General Medical Devices (GMDs) and Class B-D In Vitro Diagnostic Medical Devices (IVDMDs), as defined by MDACS classification rules.
#If there are multiple lowest confirming offers at the same price
2. Labeling Requirements for EU CE Marking
If EU CE marking is the sole reference market approval used for a new listing:
- The submitted labeling must be identical to the version approved by the EU Notified Body (NB).
- The labeling must bear the CE mark.
- If the CE mark is removed, a Change Notification must be submitted with alternative reference market approval to maintain listing validity. Otherwise, a primary evaluation (Conformity Assessment by MDD-recognized CABs) will be required.
3. Translated Instructions for Use (IFU)
For IFUs translated from languages other than English or Chinese, the translation must be supported by one of the following:
- Coverage under the supporting overseas marketing approval.
- Translation conducted by a service provider certified with ISO 17100 or equivalent.
- A notarized declaration confirming the translation accurately represents the original IFU.
Implications to Clients
If your medical device is not yet listed under the Medical Device Administrative Control System (MDACS), we strongly recommend initiating the listing process promptly to prepare for upcoming regulatory changes.
Next Steps
If you are preparing or submitting medical device listings in Hong Kong, our regulatory team can assist you in navigating the Medical Device Administrative Control System (MDACS) requirements and upcoming procurement strategy changes.
Contact us at info@nordpacificmed.com or click the button below for more details.
Credits: Thank you to Professor Jack Wong for providing this image.