To apply for Class D medical device registration under the MDACS (Medical Device Administrative Control System) in Hong Kong, you must meet a series of regulatory, technical, and procedural requirements. Class D represents the highest-risk category, including life-supporting, implantable, or critical treatment devices (e.g., pacemakers, heart valves, dialysis systems).

Below is a detailed list of requirements for Class D medical device MDACS registration in Hong Kong:

🔍 I. Regulatory Eligibility Requirements

1. Local Responsible Person (LRP)

• Must be appointed if the manufacturer is not based in Hong Kong.

• Must be a registered business in Hong Kong.

• The LRP is responsible for:

  • Submitting the MDACS application

  • Post-market surveillance

  • Vigilance reporting (e.g. adverse events, recalls)

  • Communication with the Medical Device Division (MDD)

📦 II. Device Classification

• You must confirm your device is Class D using:

  • Technical Reference TR-003 (for general medical devices)

  • Technical Reference TR-006 (for IVD devices)

• Class D includes:

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

  • Devices that sustain life or prevent life-threatening conditions

  • Implantable and critical devices

📁 III. Required Documents for Application

✅ A. Application Form

• MD 1 Form for general medical devices

• MD 100 series for IVDs (if applicable)

• Must be submitted via the MDIS online system (paper applications no longer accepted after October 2024)

✅ B. Declaration of Conformity

• Must show compliance with Essential Principles of Safety and Performance (see GN-01 and GN-02)

• Includes a signed statement from the manufacturer

✅ C. Regulatory Approval in GHTF Country

You must provide:

• Certificate of Free Sale (CFS) or equivalent approval from at least one of the following:

  • EU (CE certificate)

  • USA (FDA 510(k) or PMA)

  • Canada (Health Canada MDL)

  • Australia (TGA ARTG)

  • Japan (PMDA or MHLW)

  • China (NMPA)

  • South Korea (MFDS)

  • Singapore (HSA)

✅ D. Quality Management System (QMS)

• Valid ISO 13485:2016 certificate issued by an accredited notified body

• QMS must cover the entire production process for the device

✅ E. Risk Management Report

• Must comply with ISO 14971

• Should include:

  • Risk analysis

  • Mitigation strategies

  • Residual risk evaluation

✅ F. Clinical Evaluation Report (CER)

• Required for high-risk Class D devices

• Can include:

  • Clinical trials

  • Literature review

  • Equivalence to existing approved devices

✅ G. Technical Documentation Summary

• Device description (design, mechanism of action, components)

• Manufacturing process overview

• Software documentation (if applicable)

• Sterilization process details (if applicable)

✅ H. Labeling and Instructions for Use (IFU)

• Must be in English and/or Traditional Chinese

• Include:

  • Intended use

  • Contraindications

  • Warnings and precautions

  • Manufacturer and LRP details

  • UDI (if applicable)

✅ I. Post-Market Surveillance Plan

• Must describe:

  • Monitoring procedures

  • Adverse event reporting system

  • Field safety corrective action (FSCA) plan

  • Device recall procedures

  • Customer complaint handling system

✅ J. Other Supporting Documents

Depending on device type:

• Biocompatibility testing results (per ISO 10993)

• Electrical safety reports (IEC 60601 series)

• EMC test reports

• Software validation (for software-driven devices)

• Sterility and shelf life validation

📤 IV. Submission via MDIS (Medical Device Information System)

• All documents must be submitted through the MDIS online platform: https://www.mdd.gov.hk

• LRP must register an account and manage submissions

🕓 V. Review Process

Total timeline may range from 3 to 9 months, depending on complexity and completeness.

📌 Summary: Key Requirements Checklist

📎 Tips for Success

• Ensure all foreign certificates (FDA/CE) are valid and current

• Labeling must match the device model and intended use exactly

• Prepare to respond quickly to MDD’s requests for clarification

• Maintain traceability from manufacturer to Hong Kong distributor

• Retain all documents and distribution records for inspection

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