To apply for Class III medical device MDACS registration in Hong Kong, you must follow the guidelines set by the Medical Device Administrative Control System (MDACS), operated by the Medical Device Division (MDD) under the Department of Health (DH). Here’s a step-by-step overview of the process:

Step-by-Step Guide: Class III MDACS Registration

Step 1: Appoint a Local Responsible Person (LRP)

• The manufacturer must designate a Local Responsible Person (LRP) in Hong Kong.

• The LRP must:

  • Be a legal entity registered in Hong Kong.

  • Hold a valid Business Registration Certificate.

  • Take responsibility for registration, post-market surveillance, and liaison with the MDD.

Step 2: Prepare Supporting Documents

For Class III devices, submit a Local Application Form with the following documentation:

1. Proof of Approval from Reference Regulatory Authorities, e.g.:

   • CE Marking (EU)

   • FDA 510(k) or PMA (USA)

   • TGA approval (Australia)

   • Health Canada (Canada)

   • Japan PMDA/MHLW

2. Essential Technical Documentation (ETD):

   • Device description

   • Intended use

   • Risk classification rationale

   • Labeling and Instructions for Use (IFU)

   • Design and manufacturing information

   • Clinical evidence (if required)

   • Declaration of Conformity

3. Quality Management System Certificate:

   • Typically ISO 13485 certificate

4. Free Sale Certificate (from reference country)

5. Post-market Surveillance Plan

6. Device Images and Packaging Information

Step 3: Submit the Application

• The LRP submits the application and documents to the Medical Device Division (MDD).

• Application form: MDACS Form MDRR-1

• Submit via email or in person to the MDD office.

Step 4: Review and Listing

• The MDD will conduct a documentary review (no device testing required).

• If approved, the device will be listed in the MDACS List of Medical Devices.

• A unique Device Listing Number will be assigned.

Step 5: Maintain the Registration

• Monitor post-market performance and report any adverse events.

• Renew certificates (e.g., ISO 13485) and update documentation when necessary.

• Notify the MDD of any significant changes (e.g., labeling, manufacturer, intended use).

Fees

• As of now, MDACS registration is voluntary and free of charge, but this may change if legislation is updated in the future.

Processing Time

• Approx. 2 to 4 months, depending on completeness and complexity.

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