What is Class IV Medical Device Registration under Hong Kong MDACS?

Under the Medical Device Administrative Control System (MDACS) managed by Hong Kong's Medical Device Division (MDD), Class IV medical devices are classified as the highest-risk devices. These are typically life-sustaining, life-supporting, or implanted devices, such as:

• Heart valves

• Pacemakers

• Implantable defibrillators

• Implantable infusion pumps

MDACS is currently a voluntary system, but listing is required for participation in Hospital Authority tenders and other government procurement.

📝 How to Apply for Class IV Medical Device Registration under MDACS

1. Confirm Classification

• Verify that your product falls under Class IV using Annex 5 of the GN-01 guidance.

• Classification is based on intended use and level of risk.

2. Appoint a Local Responsible Person (LRP)

• You must designate a Local Responsible Person who is:

  • A company or individual based in Hong Kong

  • Authorized by the manufacturer

• The LRP handles the entire listing process and post-market activities.

3. Prepare the Required Documents

According to GN-02 guidance, the following are required:

Administrative Documents:

• Completed Form MD4 (Application for Device Listing)

• Declaration of conformity by the manufacturer

• Copy of business registration (for the LRP)

Device Evidence:

• Regulatory approval in at least one Reference Country (e.g., CE certificate, FDA clearance, TGA, Health Canada, PMDA)

• Instructions for Use (IFU) and labeling (English/Chinese)

• Product brochure or datasheet

• Clinical evaluation or trial reports (if required)

Technical Documentation:

• Device description and intended use

• Risk analysis or risk management report

• Summary of clinical data or validation

• Post-market surveillance plan

4. Submit Application via LRP

• The LRP registers with MDD and submits the full application dossier and Form MD4.

• Submit documents electronically and in hard copy as required.

• No government fee is currently charged under the voluntary system.

5. MDD Review & Listing

• The Medical Device Division (MDD) evaluates:

  • Safety and effectiveness

  • Evidence from reference markets

  • Proper labeling and documentation

• Once approved, the device will be listed in the “List of Medical Devices” on the MDACS website.

• The LRP will receive a Device Listing Certificate.

6. Post-Market Obligations

• Maintain a Quality Management System

• Report adverse events to MDD

• Cooperate with recalls and field safety notices

• Renew and update listing information when necessary

📌 Summary of Key Points:

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