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

Under Hong Kong's Medical Device Administrative Control System (MDACS), a Class IV medical device is one that poses the highest risk to patients or users. These include devices that:

• Are life-sustaining or life-supporting

• Are implanted in the body for a long period

• Are used in critical medical situations, such as pacemakers, heart valves, or deep brain stimulators

Though MDACS is currently voluntary, many public and private healthcare institutions require device registration for procurement. The registration is overseen by the Medical Device Division (MDD) of the Department of Health.

✅ How to Apply for Class IV Device Registration under MDACS

Step 1: Appoint a Local Responsible Person (LRP)

• Required if the manufacturer is not based in Hong Kong.

• The LRP must:

  • Be based in Hong Kong

  • Represent the manufacturer

  • Handle registration, communication, vigilance, and complaints

Step 2: Confirm Classification

• Use MDACS classification rules (aligned with GHTF/IMDRF) to confirm your device is Class IV.

• Devices are classified based on intended use, invasiveness, duration of use, and part of the body affected.

Step 3: Prepare Application Documents

You must demonstrate compliance with recognized regulatory frameworks. Provide the following:

1. Evidence of Reference Market Approval:

   • At least one of:

     • CE Marking (EU MDR/IVDR)

     • FDA approval (USA)

     • TGA Certificate (Australia)

     • Health Canada Licence

     • Japan PMDA Approval

2. Quality System Certificate:

   • e.g., ISO 13485

3. Technical and Product Documentation:

   • Device description

   • Instructions for use (IFU)

   • Product label

   • Risk analysis

   • Clinical evidence (if required)

4. Declaration of Conformity (signed by the manufacturer)

5. Completed Application Form:

   • Use Form MD-APP001 for medical devices

Step 4: Submit the Application

• Submit all documents to the Medical Device Division (MDD).

• Submission can be hard copy or electronic.

• There is currently no application fee, but this may change.

Step 5: Evaluation by MDD

• MDD reviews the application and may request clarifications or more data.

• Once satisfied, they will issue a Listing Certificate, and your device will be listed on the Medical Device List.

Step 6: Maintain Registration

• Report adverse events (vigilance system)

• Notify MDD of any changes (e.g., labeling, manufacturer, IFU updates)

• Renew certification if any future requirements are introduced

📎 Summary of Key Points

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