For Class D medical device MDACS registration in Hong Kong, the Medical Device Division (MDD) requires a comprehensive set of technical, regulatory, and administrative documents. Class D is the highest-risk classification, and thus demands the most rigorous documentation.

Here’s a detailed guide to the required documents and how to prepare the application files effectively:

📁 Part I: Required Documents for Class D MDACS Registration

✅ 1. Application Form (MD1 or MD100 series)

• Purpose: Main application form for listing the device

• How to prepare: Complete online via MDIS (Medical Device Information System) portal

• Format: Digital submission (no paper accepted since April 2024)

✅ 2. Declaration of Conformity

• Purpose: Confirms compliance with Hong Kong’s Essential Principles of Safety and Performance

• How to prepare:

  • Reference GN-01 (for general MDs) or GN-02 (for IVDs)

  • Include device model, classification, standards applied, manufacturer name

  • Must be signed and dated by the legal manufacturer

• Format: PDF

✅ 3. Certificate of Free Sale (CFS) or Regulatory Approval

• Purpose: Shows that the device is legally marketed in a GHTF-recognized country (EU, USA, Canada, Australia, Japan, China, Korea, Singapore)

• Examples:

  • CE Certificate

  • US FDA 510(k) clearance or PMA

  • Australia TGA ARTG listing

• How to prepare:

  • Use the most recent version

  • Must be issued by official authority or Notified Body

  • Include translations if not in English/Chinese

✅ 4. ISO 13485 Quality Management System Certificate

• Purpose: Confirms the manufacturer operates a certified QMS

• How to prepare:

  • Issued by an accredited certification body

  • Must be valid and include manufacturer name and site address

  • Match QMS scope with the product category

• Format: PDF with English or Chinese translation if needed

✅ 5. Risk Management Report (per ISO 14971)

• Purpose: Demonstrates systematic risk assessment and control

• How to prepare:

  • Include: risk analysis, mitigation, benefit-risk evaluation

  • Must cover entire device lifecycle

  • Must be current and device-specific

✅ 6. Clinical Evaluation Report (CER)

• Purpose: Proves the device’s safety and performance

• How to prepare:

  • Base on clinical trials, real-world evidence, or literature

  • Follow MEDDEV 2.7/1 Rev 4 or IMDRF clinical evaluation guidance

  • Must include equivalence analysis if using predicate devices

• Format: PDF; ideally <3 years old

✅ 7. Device Description and Design Summary

• Purpose: Describes how the device works and what it does

• Contents:

  • General description

  • Design features and specifications

  • Intended purpose and indications for use

  • Accessories (if any)

  • Materials, software, and electrical components (if applicable)

✅ 8. Labeling, Packaging, and IFU (Instructions for Use)

• Purpose: Evaluates the clarity and completeness of user information

• How to prepare:

  • Provide labels in English and/or Traditional Chinese

  • Include:

    • Device name and model

    • Manufacturer and LRP name/address

    • Expiry date, batch/serial number, symbols

    • Warnings, precautions, contraindications

    • Cleaning, sterilization, and storage instructions (if applicable)

✅ 9. Post-Market Surveillance (PMS) Plan

• Purpose: Shows ability to monitor and respond to device performance post-listing

• How to prepare:

  • Include:

    • Adverse event reporting process

    • Recall procedures

    • Complaint handling SOP

    • Trend analysis method

• Optional Templates: Based on ISO/TR 20416

✅ 10. Additional Technical Documentation (as applicable)

Depending on your device type, include:

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