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What is Class D medical device MDACS registration in Hong Kong? How to apply?
Release time：2025-07-08 15:28:48 The author: source:
In Hong Kong, a Class D medical device under the MDACS (Medical Device Administrative Control System) refers to the highest‑risk risk category. This includes devices that support or sustain life, are implantable, or used in critical treatments—such as pacemakers, implantable defibrillators, heart valves, dialysis systems, and ventilators

In Hong Kong, a Class D medical device under the MDACS (Medical Device Administrative Control System) refers to the highest‑risk risk category. This includes devices that support or sustain life, are implantable, or used in critical treatments—such as pacemakers, implantable defibrillators, heart valves, dialysis systems, and ventilators.

How to Apply for Class D MDACS Listing in Hong Kong

1. Confirm Classification

Use MDD’s Technical Reference TR‑003 (for general MDs) or TR‑006 (for IVDs) and follow GHTF/IMDRF criteria to determine if your device is Class D.

2. Appoint a Local Responsible Person (LRP)

Foreign manufacturers must designate an LRP based and registered in Hong Kong—responsible for submission, post‑market surveillance, adverse events, and recalls.


3. Registration via MDIS (Online System)

As of 2 April 2024, MDACS submissions are digital via MDIS. Paper submissions were phased out by October 14, 2024


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