Hong Kong Medical Device Regulation
Regulatory authority: Medical Device Division (MDD), Department of Health | System: MDACS | Last reviewed: May 2026 | For reference only — not legal advice.
Hong Kong regulates medical devices through the Medical Device Administrative Control System (MDACS), an administrative framework that is technically voluntary but de facto mandatory for public procurement and broad market access. The Medical Device Division (MDD) of the Department of Health manages MDACS.
Key Facts
| Regulatory body | Medical Device Division (MDD), Department of Health |
| System | MDACS (administrative, not statutory) |
| Classification | Class I–IV (general) · Class A–D (IVD) — IMDRF-aligned |
| Local rep required | Yes — Local Responsible Person (LRP) for foreign manufacturers |
| Application fee | None (MDD charges no fee) |
| Procurement mandate | Stage C from 23 March 2026 — mandatory listing for public DH tenders |
What This Site Covers
- Getting Started — definitions, who must comply, lifecycle overview
- Classification — Class I–IV (TR-003) and Class A–D IVD (TR-004)
- MDACS Listing — standard and expedited reliance pathways, MDIS system
- Pre-Market — technical documentation, essential principles, clinical evidence
- Post-Market — adverse event reporting, FSCAs, PMS, labelling
- LRP & Market Access — Local Responsible Person obligations, procurement strategy
- Legislation — MDACS Technical References, applicable ordinances
- Digital Health & SaMD — MDD approach to software and AI/ML
No standalone Medical Device Ordinance yet
Hong Kong does not yet have a statutory medical device law. A proposed Medical Devices Ordinance is under development. See What's New for the latest.
Part of the RAPath suite — medical device regulatory reference.