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Where to register and apply for Class D medical device MDACS registration in Hong Kong?
Release time：2025-07-08 15:32:06 The author: source:
To register and apply for Class D medical device MDACS registration in Hong Kong, the application must be submitted through the Medical Device Information System (MDIS), which is managed by the Medical Device Division (MDD) under the Department of Health (DoH), Hong Kong SAR.

To register and apply for Class D medical device MDACS registration in Hong Kong, the application must be submitted through the Medical Device Information System (MDIS), which is managed by the Medical Device Division (MDD) under the Department of Health (DoH), Hong Kong SAR.

🏛️ Where to Register

✅ Registration Authority:

Medical Device Division (MDD)
Department of Health, Hong Kong SAR Government
Official Website: https://www.mdd.gov.hk

🌐 Online Registration Platform (MDIS)

As of April 2, 2024, all applications must be submitted online via MDIS (Medical Device Information System).
Paper-based submissions were officially phased out after October 14, 2024.

🔗 MDIS Portal:

https://www.mdd.gov.hk/en/mdacs/mdis/index.html

📌 MDIS Capabilities:

  • Online submission of MDACS applications

  • Tracking application status

  • Uploading supporting documents

  • Managing device listings

  • Managing Local Responsible Person (LRP) account details

🧾 Who Can Submit the Application?

Only a Local Responsible Person (LRP) based in Hong Kong can submit the registration on behalf of the manufacturer.

✅ LRP Requirements:

  • Must be a Hong Kong-registered business entity

  • Must have access to MDIS

  • Responsible for:

    • Regulatory correspondence

    • Post-market surveillance

    • Vigilance and recall reporting

🗂️ Submission Process Overview via MDIS

StepAction
Step 1Create an account on MDIS as a Local Responsible Person (if not already registered)
Step 2Prepare required documents (e.g. MD1 form, QMS, labeling, clinical data)
Step 3Upload documents via MDIS and fill in device details
Step 4Submit application for review
Step 5Track and respond to any MDD queries via the MDIS dashboard

🏢 Physical Address (for reference or communication)

Medical Device Division (MDD)
Office of the Director of Health
Room 3101, 31/F, Hopewell Centre,
183 Queen’s Road East, Wan Chai,
Hong Kong SAR

📞 Telephone: +852 3107 8484
📧 Email: mdd@dh.gov.hk

⚠️ Note: In-person or postal applications are no longer accepted for MDACS listing.

📝 Summary

ItemDetails
Where to Registerhttps://www.mdd.gov.hk
PlatformMDIS (Medical Device Information System)
Application MethodOnline submission only
Who Can ApplyLocal Responsible Person (LRP) based in Hong Kong
Responsible AuthorityMedical Device Division, Department of Health

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Contact Us：

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


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