Here's a comprehensive overview of the procedures, required documents, and key considerations for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS):

✅ 1. Overview of the MDACS Registration System

• MDACS is a voluntary system administered by the Medical Device Division (MDD) under Hong Kong’s Department of Health.

• Devices are classified into Classes I–IV, with Class IV representing the highest risk (e.g., implantable defibrillators, heart valves).

• Only Class II, III, and IV devices need to be listed for MDACS participation.

• Listing is required for supply to public hospitals and government tenders.

🧭 2. Procedures for Class IV Medical Device Registration

Step-by-Step Process:

📄 3. Required Documents for Class IV MDACS Application

A. Administrative Documents

• ✅ Form MD4: Application for Listing Class II/III/IV Medical Devices

• ✅ LRP registration confirmation (Form MD1 previously submitted)

• ✅ Letter of Authorization from manufacturer to the LRP

• ✅ Copy of Business Registration Certificate of the LRP

• ✅ Reference Country Approval (e.g., CE Certificate, FDA 510(k)/PMA, TGA, etc.)

• ✅ Manufacturer’s Declaration of Conformity

B. Technical Documentation

• ✅ Device Description and intended use

• ✅ Design and Manufacturing Information

• ✅ Risk Analysis File (e.g., per ISO 14971)

• ✅ Clinical Evaluation Report (e.g., MEDDEV 2.7/1 Rev. 4 or MDR Annex XIV)

• ✅ Quality Management System Certificate (e.g., ISO 13485)

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

• ✅ Post-market Surveillance Plan

• ✅ Product Photos, Brochure, and Marketing Materials

🔑 4. Key Considerations

✔ Local Responsible Person (LRP)

• Must be based in Hong Kong

• Official liaison with MDD and responsible for post-market surveillance

✔ Reference Country Requirement

• Only devices approved in one or more of the designated countries are eligible:

  • EU (CE-marked under MDR/IVDR)

  • USA (FDA 510(k) or PMA)

  • Australia (TGA)

  • Canada (Health Canada MDL)

  • Japan (PMDA/MHLW)

✔ Language Requirements

• All documents must be in English or Chinese

• Labels and IFU must comply with Hong Kong standards

✔ Validity and Changes

• While there is no expiry for listing, the MDD must be notified of:

  • Design changes

  • Labeling/IFU changes

  • Change in LRP or manufacturer details

  • Market withdrawals or safety notices

✔ Post-market Obligations

• Report adverse incidents to the MDD

• Maintain vigilance and risk control systems

📬 Submission

Submit all documents to:

Medical Device Division (MDD)
Department of Health
Units 2-3, 11/F, Energy Plaza, 92 Granville Road
Tsim Sha Tsui East, Kowloon, Hong Kong

Currently, there is no government fee for registration.

Would you like a downloadable checklist or template set (e.g., Form MD4 sample, Authorization Letter, Clinical Evaluation Report outline)?

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn