Handling Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) involves several structured steps, as overseen by the Medical Device Division (MDD) of the Department of Health. Here's a detailed guide for Class IV (highest risk) devices:

🔷 1. Understand MDACS Framework

Hong Kong operates a voluntary listing scheme under MDACS (not mandatory yet, unless for public hospital procurement). However, registration is recommended for market acceptance and public tenders.

🔷 2. Determine Device Classification

Ensure your product is indeed Class IV, typically including:

• Implantable devices

• Life-supporting/sustaining devices

• Devices with significant risk to patients (e.g., heart valves, pacemakers)

Classification should align with Annex 5 of the “Guidance Notes GN-01: Overview of the Medical Device Administrative Control System.”

🔷 3. Appoint a Local Responsible Person (LRP)

You must appoint an LRP who is either:

• Based in Hong Kong; and

• Authorized by the overseas manufacturer

The LRP will:

• Submit the application

• Maintain post-market surveillance

• Act as liaison with the MDD

🔷 4. Prepare Technical Documentation

Submit documentation according to GN-02: Guidance Notes for Listing Class II/III/IV Medical Devices. Requirements include:

• Manufacturer’s Declaration of Conformity

• Risk analysis documents

• Design dossier (if applicable)

• Clinical evaluation report

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

• Declaration of Conformity with international standards

🔷 5. Provide Proof of Reference Country Approval

The device should already be approved in at least one "Reference Country", which includes:

• USA (FDA)

• EU (CE mark under MDR)

• Australia (TGA)

• Canada (Health Canada)

• Japan (PMDA)

Submit relevant certificates such as:

• CE Certificate + Declaration of Conformity

• FDA 510(k) clearance or PMA

• TGA ARTG listing

• Health Canada MDL

• Japan Shonin approval

🔷 6. Application Submission via LRP

Your LRP should:

• Register as an LRP under MDACS

• Submit Form MD4 for the Class IV device listing

• Pay any applicable fees (currently nominal as MDACS is voluntary)

🔷 7. Listing Review by MDD

The Medical Device Division will assess:

• Safety and effectiveness

• Proper labeling and documentation

• Compliance with reference country requirements

If approved, the device will be added to the MDACS List of Medical Devices, and the LRP will receive a Device Listing Certificate.

🔷 8. Post-market Obligations

• Maintain a quality management system (QMS)

• Report adverse events to the MDD

• Submit annual declarations if requested

• Cooperate in surveillance and recalls

📌 Notes:

• MDACS is voluntary, but all devices used in public hospitals or tenders must be listed.

• The Department of Health may conduct random audits or request additional documents.

• Hong Kong does not yet have a formal regulatory law, but this may change in future.

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