To continuously enhance the safety, quality, and performance of medical devices used in public healthcare institutions, the Hong Kong Department of Health (DH) is steadily advancing its phased implementation of new procurement regulations.
According to the latest announcement, following the initial implementation of Phase A in June 2023 and Phase B in November 2024, the critical Phase C measures will officially take effect on March 23, 2026, marking the full deepening of the new regulatory system.
Core of the New Regulations: Phased Strengthening of “Listing” Requirements
The reform of these procurement regulations is a gradual, step-by-step process:
- Phase A (First Phase):
Implemented on June 21, 2023, initiating preliminary adjustments to procurement standards. - Phase B (Second Phase, Part 1):
Effective from November 1, 2024, requiring that all “Applicable Medical Devices” procured through quotation methods must either be successfully listed in the “Medical Device Administrative Control System” or, at a minimum, have a listing application submitted and an application number issued before the tender closing date. - Phase C (Second Phase, Part 2):
Coming into effect on March 23, 2026. This phase will further tighten requirements, stipulating that all procured “Applicable Medical Devices” must be successfully listed medical devices. The option of merely having a submitted application will no longer be accepted.
What are “Applicable Medical Devices”?
According to the announcement’s notes, “Applicable Medical Devices” specifically refer to general medical devices classified as Class II, III, or IV, and in vitro diagnostic medical devices classified as Class B, C, or D under the Medical Device Administrative Control System. These medium to high-risk categories are the primary focus of the new regulations.
Urgent Notice and Action Guide for the Industry
The DH explicitly states in the announcement that it anticipates a significant increase in listing applications due to the implementation of Phase C measures. To ensure smooth procurement processes and avoid missing business opportunities, the DH strongly advises suppliers and manufacturers intending to participate in its medical device tenders or quotations to act immediately:
- Complete Listing Applications Promptly
Immediately verify whether the products you plan to supply qualify as “Applicable Medical Devices” and are already successfully listed. If not, submit a “Medical Device Listing Application” as soon as possible. - Allow Sufficient Processing Time
To ensure applications can be approved before the March 2026 deadline, plan ahead and allow ample time for the DH to process your application.
With the final deadline of March 2026 approaching, the relevant medical device industry should treat this as a priority, completing compliance preparations early to adapt to the new procurement environment, ensure business continuity, and seize opportunities in the public healthcare market.
Original Link: https://www.mdd.gov.hk/sc/whats-new/procurement-requirement/index.html
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