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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.

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
Hong Kong definition under the Medical Device Ordinance — scope, exclusions, and key terms.
Read definition →
Getting Started
Regulatory Framework
MDACS, Medical Device Division of DOH, and the Medical Device Ordinance explained.
View framework →
Getting StartedKey step
Who Must Comply?
Obligations for manufacturers, importers, distributors, and Local Responsible Persons (LRPs).
Check obligations →

Key Facts​

Regulatory bodyMedical Device Division (MDD), Department of Health
SystemMDACS (administrative, not statutory)
ClassificationClass I–IV (general) · Class A–D (IVD) — IMDRF-aligned
Local rep requiredYes — Local Responsible Person (LRP) for foreign manufacturers
Application feeNone (MDD charges no fee)
Procurement mandateStage 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, special device types
  • Quality System — ISO 13485 requirements for manufacturers, LRP QMS obligations, GDP
  • Post-Market — adverse event reporting, FSCAs, recalls, PMS plan, PMCF, 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, cybersecurity
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.