Here is a detailed breakdown of the procedures and steps for registering a Class III medical device under MDACS in Hong Kong:

✅ Procedures and Steps for Class III MDACS Registration (Hong Kong)

Step 1: Determine Device Classification

• Confirm the device is Class III based on Hong Kong’s risk-based classification system (aligned with GHTF).

• Class III = high-risk, e.g.:

  • Life-supporting or sustaining devices

  • Implantable devices

Step 2: Appoint a Local Responsible Person (LRP)

• The manufacturer must appoint a Local Responsible Person (LRP) who is:

  • A legal entity in Hong Kong,

  • Holding a valid Business Registration Certificate,

  • Responsible for registration, post-market obligations, and communication with the MDD.

Step 3: Prepare Required Documentation

The following documents must be compiled and submitted by the LRP:

A. Application Form

• Use Form MDRR-1: Application for Listing of Medical Devices.

B. Reference Regulatory Approval

Provide evidence of approval from at least one reference regulatory authority, such as:

• CE Certificate (EU MDR)

• FDA 510(k) or PMA (USA)

• Health Canada License

• TGA Certificate (Australia)

• PMDA/MHLW Approval (Japan)

C. Essential Technical Documentation (ETD)

Include:

• Device description

• Intended use and indications

• Classification rationale

• Risk assessment

• Design and manufacturing details

• Labeling and Instructions for Use (IFU)

• Clinical evidence (if applicable)

D. Quality Management System Certificate

• Typically ISO 13485 certificate (issued by an accredited body).

E. Free Sale Certificate

• From a competent authority of the reference country.

F. Post-market Surveillance (PMS) Plan

• Outline complaint handling, vigilance, and recall procedures.

Step 4: Submit the Application

• The LRP submits the completed MDRR-1 form and all supporting documents to the Medical Device Division (MDD):

  • Via email: mdd@dh.gov.hk

  • Or by post/in person at MDD’s office.

Step 5: Review by MDD

• The MDD will perform a document-based review.

• There is no need for product testing.

• Queries or requests for additional information may be issued during review.

Step 6: Device Listing

• If approved:

  • The device will be listed in the “List of Medical Devices” on the MDD website.

  • A unique Listing Number will be assigned.

  • The listing remains valid as long as supporting documents (e.g., ISO certificate, CE/FDA approval) are up to date.

Step 7: Maintain Registration

• Ensure post-market obligations:

  • Report adverse events

  • Maintain up-to-date documentation

  • Notify MDD of changes (e.g., manufacturer, label, intended use)

⏱️ Processing Time

• Typically 2 to 4 months, depending on the completeness and complexity of the submission.

💰 Fees

• No fees for MDACS registration at present (voluntary system).

Would you like a downloadable checklist or template for the application submission?

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