Hong Kong DH Mandates Medical Device Listing for Public Procurement by March 2026

On December 18, 2025, the Hong Kong Department of Health (DH) announced the formal implementation of Stage C under its enhanced procurement strategy. This update mandates that all applicable medical devices (AMDs) procured by the DH must be listed under the Medical Device Administrative Control System (MDACS) starting March 23, 2026. The transition is part of a multi-year effort to integrate administrative listing with government purchasing power, ensuring that only devices vetted for safety and quality enter the public health system.

While Stage C specifically targets DH procurement, it signals a broader market shift. It does not yet create a universal mandatory listing requirement for Hospital Authority (HA) procurement; however, the HA continues to increase its use of MDACS status as a tender condition or evaluation preference.

Hong Kong’s Enhanced Procurement Strategy

The MDACS-based enhanced procurement strategy is part of phased approach by the DH to strengthening oversight of medical devices used in public healthcare.

By linking public procurement eligibility to MDACS listing status, the DH effectively enforces a high standard of safety, quality, and performance for devices used in public clinics and facilities. This strategy also serves as a critical bridge, familiarizing suppliers with Hong Kong’s administrative control framework ahead of any future regulatory developments.

The implementation follows a logical progression of oversight that began in 2023, moving from basic preferences to the current requirements for high-risk and medium-risk devices.

StageEffective DateDescription of Procurement RequirementStage AJune 21, 2023Introduced a preference for MDACS-listed devices in DH procurement.Stage BNovember 1, 2024Required AMDs to be listed or have a submitted listing application with an assigned number. Tenders award technical marks for MDACS-listed AMDs.Stage CMarch 23, 2026Mandatory MDACS listing required for all AMDs to be eligible for public procurement.

Devices Affected by Mandatory MDACS Listing

Stage C focuses specifically on AMDs as defined under the classification rules of the “Medical Device Administrative Control System.” Foreign manufacturers must identify if their products fall into the high-risk or medium-risk categories that are now subject to these mandatory procurement requirements.

For general medical devices, this includes Class II, III, and IV products. For in-vitro diagnostic (IVD) medical devices, the requirement applies to Class B, C, and D products.

With the shift to mandatory status, pending applications will no longer be sufficient. Suppliers must hold a valid MDACS Certificate of Listing, and the listing must remain active at the DH tender or quotation closing date.

Industry Impact: Toward Mandatory Registration for All Medical Devices

Currently, Stage C only affects devices procured by the DH. Devices sold to private hospitals and clinics are not yet subject to MDACS listing. However, mandatory statutory registration for all medical devices, including those for the private sector, is expected soon.

At multiple conferences last year, the Medical Device Division encouraged manufacturers and overseas suppliers to obtain MDACS listing early because:

• Application fees are currently free-of-charge under MDACS.
• Fees may apply once new legislation is enacted.
• Early listing will smooth the transition to the future mandatory registration system.

Early MDACS listing will help manufacturers transition smoothly to the future registration system..

Recommended Next Steps

As a result of these changes, the DH anticipates a surge in listing applications. Manufacturers and Local Responsible Persons (LRPs) should prepare accordingly:

1. Identify all AMDs (Class II–IV and Class B–D IVDs) in your portfolio.
2. Submit accurate and complete listing applications via the MDIS e platform.
3. Verify that certificates remain valid through the closing date of any tender or quotation.
4. Monitor DH updates and subscribe to InstruMedica@DH for alerts.

Why Act Now?

• Application volumes are expected to surge
• MDACS processing typically takes around 12 weeks after complete submission
• Non-listed devices will be ineligible for DH procurement after March 2026.

Final Thoughts: Securing Your Position in Hong Kong’s Medical Devices Market

With the March 2026 deadline fast approaching and mandatory regulation on the horizon, early action is critical. As an established Local Responsible Person (LRP) in Hong Kong, Cisema provides end-to-end regulatory support for MDACS listings, serving as the direct link between the manufacturer and the Medical Device Division. Our services include regulatory strategy, dossier preparation, MDACS submission, and ongoing compliance monitoring to keep your listings valid.

Get in touch with Cisema today to facilitate your MDACS listings and ensure your compliance with Hong Kong’s evolving procurement and regulatory requirements.

Further Information

Explore Cisema's Hong Kong Medical Device Listing Services, including dossier submissions for SaMDs and AI medical devices, Local Responsible Person (LRP) duties and post-market responsibilities.

About the Author: Jacky Li

Jacky Li is a Senior Manager at Cisema, based in Hong Kong and Taiwan. He has over a decade of experience in regulatory intelligence and market access, and serves as the lead supporting clients across Hong Kong, Mainland China (including the Greater Bay Area), and Taiwan, with a strong focus on pharmaceutical and medical device regulatory projects.

References

• Department of Health to implement enhanced measures for procurement of medical devices, last update on December 18, 2025 by MDD