What is Class III Medical Device MDACS Registration in Hong Kong?

Class III medical devices under Hong Kong’s Medical Device Administrative Control System (MDACS) are high-risk medical devices, such as:

• Implantable devices (e.g., pacemakers, orthopedic implants),

• Life-supporting or life-sustaining equipment (e.g., ventilators).

MDACS is a voluntary listing system managed by the Medical Device Division (MDD) under the Department of Health (DH). It aims to ensure medical device safety, performance, and quality in the absence of a statutory registration framework (though regulations may become mandatory in the future).

How to Apply for Class III MDACS Registration

Here is a step-by-step guide:

✅ Step 1: Appoint a Local Responsible Person (LRP)

• The manufacturer must designate an LRP in Hong Kong.

• The LRP:

  • Must be a registered Hong Kong entity.

  • Handles registration, post-market surveillance, and communication with the MDD.

✅ Step 2: Prepare Required Documents

You will need:

1. Application Form

   • MDRR-1: Application for Listing of Medical Device

2. Proof of Approval by a Reference Regulatory Authority

   • At least one from:

     • FDA (USA)

     • CE Marking (EU)

     • Health Canada

     • TGA (Australia)

     • Japan PMDA/MHLW

3. Essential Technical Documentation (ETD)

   • Device description and intended use

   • Risk classification justification

   • Safety and performance data

   • Instructions for Use (IFU)

   • Clinical evidence (if applicable)

4. Quality System Certificate

   • Usually ISO 13485 from a recognized body

5. Free Sale Certificate

   • Issued by the competent authority in the reference country

6. Post-market Surveillance Plan

✅ Step 3: Submit the Application

• The LRP submits the completed MDRR-1 form and documentation to the Medical Device Division.

• Submission options:

  • Email to mdd@dh.gov.hk

  • Or in person/mail to MDD’s office

✅ Step 4: Review and Listing

• The MDD reviews the documents (no physical testing required).

• If accepted, the device is listed on the MDACS List of Medical Devices with a unique device listing number.

✅ Step 5: Maintain Compliance

• Keep documents (e.g., ISO 13485, reference approvals) updated.

• Report adverse events and make updates when necessary.

• Notify MDD of major changes (e.g., labeling, intended use).

⏱️ Processing Time

• Approximately 2–4 months, depending on submission completeness.

💰 Fees

• Currently free, since MDACS is voluntary (as of 2025). This may change with future legislation.

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