MDACS — Voluntary System Explained

HK-unique · De facto mandatory market access requirement

Official Voluntary Status vs Market Reality

MDACS listing is officially voluntary — no current Hong Kong law mandates device registration before sale. In practice, listing is essential because:

1. Public hospital procurement — DH progressively requires MDACS listing for all applicable medical devices in public tenders
2. Private healthcare — most private hospitals independently require MDACS evidence
3. Market credibility — an HKMD listing number signals compliance to healthcare buyers

DH Procurement Phases

Stage	Date	Requirement
Stage A	June 2023	Preference for listed devices in DH tenders
Stage B	November 2024	Listed or application submitted with assigned number
Stage C	23 March 2026	Mandatory listing for all AMDs in DH procurement

Applicable Medical Devices (AMDs)

• General: Class II, III, IV
• IVD: Class B, C, D

Class I (general) and Class A (IVD) are not subject to the procurement mandate.

Stage C becomes effective 23 March 2026.

To remain eligible for DH public procurement from this date forward, all applicable medical devices (Classes II–IV / IVD B–D) must have either: (1) a valid MDACS listing, or (2) a pending application with an assigned reference number submitted before 23 March 2026. Devices without either status will be ineligible for DH tender participation.

Devices with applications submitted before 23 March 2026 but not yet approved may be subject to transition provisions. Contact the MDD for clarification on in-flight applications near the deadline.