Requirements for Class III Medical Device MDACS Registration in Hong Kong

To register a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must comply with the requirements set by the Medical Device Division (MDD). Below are the key requirements:

🔹 1. Device Classification

• The product must be a Class III medical device, which typically includes:

  • Life-supporting or sustaining devices,

  • Devices implanted in the human body,

  • Devices with significant risk if they fail.

MDACS classification follows GHTF guidelines.

🔹 2. Local Responsible Person (LRP)

• The manufacturer must appoint an LRP based in Hong Kong.

• The LRP must:

  • Be a legal entity registered in Hong Kong,

  • Hold a Business Registration Certificate,

  • Be responsible for submission, communication, and post-market actions.

🔹 3. Application Form

• Complete and sign Form MDRR-1:
  Download from MDD Website

🔹 4. Reference Regulatory Approval

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

  • EU (CE under MDR/IVDR),

  • USA (FDA 510(k) or PMA),

  • Canada (Health Canada),

  • Australia (TGA),

  • Japan (PMDA/MHLW).

🔹 5. Essential Technical Documentation (ETD)

Include the following:

• Device description

• Intended use and indications

• Risk classification justification

• Labeling and Instructions for Use (IFU)

• Design and manufacturing information

• Clinical evidence (if applicable)

• Summary of safety and performance

🔹 6. Quality Management System (QMS) Certificate

• Submit a valid ISO 13485 certificate issued by a recognized certification body.

🔹 7. Free Sale Certificate

• Issued by the competent authority of the reference country,

• Confirms the device is legally sold or distributed in that country.

🔹 8. Post-Market Surveillance (PMS) Plan

• A documented plan covering:

  • Adverse event reporting,

  • Complaint handling,

  • Corrective and preventive actions (CAPA),

  • Product recall procedures.

🔹 9. Product Images and Packaging

• Clear photos or renderings of:

  • The device itself,

  • Outer and inner packaging,

  • Labeling.

🔹 10. Other Optional Documents (If Applicable)

• Test reports or declarations of conformity,

• Clinical evaluation reports (CERs),

• Certificates from notified bodies or third-party testing labs.

📝 Summary Table of Requirements

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