Hong Kong's Enhanced Medical Device Procurement Strategy moves into Stage C in March 2026, making MDACS listing mandatory for Department of Health procurement.
Hong Kong’s medical device regulatory landscape is undergoing its most significant transformation in over a decade. The Medical Device Division (MDD) has announced a phased transition from the long‑standing voluntary Medical Device Administrative Control System (MDACS) to a mandatory device listing framework.
Mandatory MDACS Listing for Government Procurement
Hong Kong’s Enhanced Medical Device Procurement Strategy is implemented in stages:
Stage A — Effective June 21, 2023
Quotation requirement: Preference to listed devices
Tender requirement: Preference to listed devices + technical score bonus
Stage B — Effective November 1, 2024
Quotation requirement: Listed devices OR submitted listing application
Tender requirement: Listed devices OR submitted listing application
Stage C — Effective March 23, 2026
Quotation requirement: Must be MDACS‑listed
Tender requirement: Must be MDACS‑listed
Under Stage C, all applicable medical devices (Class II/III/IV general medical devices and Class B/C/D IVDs) procured by the Department of Health must hold a valid MDACS listing. Suppliers must provide a copy of the valid listing certificate with HKMD listing number at the time of quotation or tender submission.
This shift reflects Hong Kong’s commitment to strengthening patient safety, aligning with international regulatory practices, and enhancing post-market surveillance. Under the new direction, Class II, III, and IV medical devices will be required to undergo compulsory listing, supported by updated documentation, technical files, and Local Responsible Person (LRP) obligations.
Manufacturers will need to demonstrate compliance with recognized regulatory approvals, provide QMS evidence (ISO 13485 or accepted equivalents), and ensure labeling and IFU meet Hong Kong requirements. The transition also introduces clearer expectations for adverse event reporting, device traceability, and post-market monitoring.
For global and regional MedTech companies, the move from voluntary to mandatory listing signals a more structured, predictable regulatory environment — one that requires earlier planning and stronger documentation readiness.
Sources:
MDACS — Official Notices
MDD — “Useful Information” Updates
Hong Kong Government Regulatory Announcements (2025–2026)
