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 is active from 23 March 2026

Ensure MDACS listing is secured before this date to remain eligible for DH public procurement.