To handle Class D medical device MDACS registration in Hong Kong, you must follow the Medical Device Administrative Control System (MDACS) operated by the Medical Device Division (MDD) under the Department of Health (DoH), Hong Kong. Class D represents the highest risk category under the MDACS system and includes critical life-sustaining or life-supporting devices (e.g. heart valves, implantable defibrillators).

Below is a detailed step-by-step guide on how to handle Class D MDACS registration in Hong Kong:

✅ Step 1: Understand the Regulatory Framework

• MDACS is currently a voluntary registration system pending the full enforcement of the Medical Device Ordinance (yet to be enacted).

• However, registration is required for public hospital tenders, medical device importation, and hospital procurement.

• The system classifies devices into Classes A to D, based on risk. Class D is the highest.

✅ Step 2: Identify Key Entities

1. Local Responsible Person (LRP):

   • Must be a legal entity registered in Hong Kong.

   • Required to handle submission, post-market surveillance, and adverse event reporting.

2. Manufacturer:

   • Responsible for technical documentation, safety, and compliance with international standards (e.g. ISO 13485).

✅ Step 3: Confirm Classification as Class D

Follow MDACS's risk classification rules based on the intended use, duration of contact, and invasiveness. Class D typically includes:

• Implantable medical devices

• Devices for supporting/sustaining life

• Devices in direct contact with the heart, CNS, or central circulatory system

Refer to the "Guidance Notes for Classification System for Medical Devices" (GN-01).

✅ Step 4: Prepare Required Documentation

For Listing under MDACS, the LRP must prepare and submit the following:

1. Application Forms

• Form: MD1 - Listing Application Form for Medical Devices

2. Essential Documents

• Free Sale Certificate (FSC) from a recognized country (e.g. EU, US, Canada, Australia, Japan).

• Evidence of registration/approval in one or more Global Harmonization Task Force (GHTF) countries.

• Declaration of Conformity

• Labeling and Instructions for Use (IFU) (English and/or Chinese)

• Quality System Certificate (e.g. ISO 13485)

• Risk Management Report (ISO 14971)

• Clinical evaluation report (CER) (if applicable)

• Device Description + Technical File Summary

• Post-market surveillance procedures

✅ Step 5: Submit Application to MDD

• Submission is made by the LRP to the Medical Device Division either in person or by post.

• The application can be made for individual devices or family groups (devices with the same manufacturer, class, and intended use).

✅ Step 6: Application Review

The Medical Device Division will:

1. Check the completeness of documentation.

2. Verify overseas approvals.

3. Assess compliance with safety and performance standards.

4. Possibly request supplementary information.

5. If accepted, issue a “Listing Certificate” (valid indefinitely under current system unless changes occur).

✅ Step 7: Maintain Device Listing

After registration, you must:

• Notify MDD of any device updates, recalls, or safety alerts.

• Submit Annual Declaration of Conformity (if required).

• Ensure continuous compliance with ISO standards and MDACS guidelines.

✅ Step 8: Costs and Timelines

✅ Step 9: Post-Market Obligations

• Establish and maintain a Post-Market Surveillance (PMS) system.

• Report adverse events and field safety corrective actions (FSCA).

• Retain distribution records for traceability.

✅ Notes on Future Regulatory Development

• The Medical Device Ordinance (MDO) will eventually make registration mandatory.

• Devices already listed under MDACS will likely be given transitional recognition.

✅ Resources

• MDACS Official Website

• Guidance Notes GN-01 to GN-10

• Application Forms

• Recognized Markets List (e.g. EU, US, Canada, Australia, Japan)

If you are planning to register a specific Class D device (e.g. cardiovascular stents, implantable pumps), I can provide a tailored checklist and estimated preparation timeline for your product. Would you like that?

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