The procedures and steps for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) are clearly structured but voluntary (as of now), managed by the Medical Device Division (MDD) of the Department of Health. Class IV devices are high-risk devices such as implantable or life-supporting medical devices.

🔷 Step-by-Step Procedures for Class IV Medical Device Registration under MDACS

STEP 1: Confirm Classification

• Use GN-01 guidance (Annex 5) to confirm your device is Class IV.

• Examples of Class IV devices:

  • Implantable pacemakers

  • Implantable defibrillators

  • Heart valves

  • Implantable infusion pumps

STEP 2: Appoint a Local Responsible Person (LRP)

MDACS requires a Local Responsible Person (LRP) based in Hong Kong, who:

• Must be a registered business entity in Hong Kong

• Acts on behalf of the manufacturer

• Is responsible for:

  • Submitting the application

  • Ensuring post-market surveillance

  • Reporting incidents

The LRP must register first under MDACS using Form MD1.

STEP 3: Collect Regulatory Approval Evidence

The device must already be approved or listed in at least one reference market, which includes:

• USA (FDA)

• EU (CE marking under MDR)

• Australia (TGA)

• Canada (Health Canada)

• Japan (PMDA)

You’ll need:

• Approval certificates (e.g., CE certificate, FDA 510(k)/PMA)

• Manufacturer’s Declaration of Conformity

• Valid quality system certificate (e.g., ISO 13485)

STEP 4: Prepare Technical & Administrative Documentation

Required documentation includes:

🗂️ Administrative:

• Form MD4 (Application for listing of Class II/III/IV devices)

• Business registration certificate of the LRP

• Authorization letter from the manufacturer to the LRP

• Declaration by the manufacturer of conformity to safety/quality requirements

📁 Technical:

• Device description and intended use

• Instructions for Use (IFU) and labelling (in English or Chinese)

• Clinical evaluation or summary of clinical evidence

• Risk analysis and design dossier (for high-risk or novel devices)

• Post-market surveillance plan

• Manufacturing site details

• Product brochures or catalogues

STEP 5: Submit the Application to MDD

• The LRP submits a full application with Form MD4 to the Medical Device Division.

• Submit both electronic and hard copy documents as required.

• There is currently no government fee under the voluntary system.

STEP 6: Review and Evaluation by MDD

• The Medical Device Division will:

  • Verify reference country approval

  • Assess conformity with recognized safety and performance standards

  • Evaluate labeling and instructions

If additional information is needed, MDD will contact the LRP during the process.

STEP 7: Listing on MDACS Database

• Once approved, the device will be:

  • Added to the “List of Medical Devices” maintained by MDACS

  • Issued a Device Listing Certificate (non-statutory but useful for tenders)

  • Made eligible for use in public hospitals and government procurement

STEP 8: Post-Market Obligations

Even after listing, the LRP must:

• Report adverse incidents to MDD

• Cooperate with MDD in case of product recalls or field safety corrective actions

• Maintain up-to-date documentation

• Inform MDD of any significant changes (e.g., design, intended use, labeling)

📌 Summary Table

Would you like downloadable templates (e.g., Form MD4) or an editable checklist to manage your application documents?

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