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Where to register and apply for Class C medical device MDACS registration in Hong Kong?
Release time：2025-06-25 15:37:24 The author: source:
To register and apply for Class C medical device listing under the MDACS (Medical Device Administrative Control System) in Hong Kong, you must submit your application and supporting documents directly to the Medical Device Division (MDD) of the Department of Health.

To register and apply for Class C medical device listing under the MDACS (Medical Device Administrative Control System) in Hong Kong, you must submit your application and supporting documents directly to the Medical Device Division (MDD) of the Department of Health.

🏢 Where to Register and Submit the Application

🔹 Registration Authority:

Medical Device Division (MDD)
Department of Health, Hong Kong SAR Government

🔹 Submission Address:

Room 3101, 31st Floor, Hopewell Centre
183 Queen’s Road East, Wan Chai, Hong Kong

📞 Telephone: +852 3107 8451
📠 Fax: +852 3157 1286
📧 Email (general inquiries): mdd@dh.gov.hk
🌐 Official Website: https://www.mdd.gov.hk

📦 How to Submit the Application

As of now, MDACS applications must be submitted physically—no online submission platform is available.

🔹 Submit the following:

  • Form MD102 – Application for Device Listing

  • Form MD100 – Application for Local Responsible Person (if applicable)

  • Form MD101 – Manufacturer Listing Application

  • Technical documentation (hard copy)

  • Soft copy of the full submission on USB flash drive or CD-ROM

📎 Submit in a clearly labeled folder, with document index and labeling in English or Chinese.

✅ Who Can Submit the Application?

Only the Local Responsible Person (LRP) can legally submit the application on behalf of the manufacturer if the manufacturer is not located in Hong Kong.

Requirements for LRP:

  • Must be a legal entity registered in Hong Kong

  • Authorized by the manufacturer through a formal declaration or appointment letter

  • Must first register as an LRP with the MDD using Form MD100

🔐 The LRP is responsible for all regulatory communication, post-market surveillance, adverse event reporting, and notifications of changes.

📌 Optional: Pre-Submission Consultation

You may request a non-binding pre-submission consultation with the MDD to:

  • Clarify documentation requirements

  • Confirm device classification

  • Discuss reference market acceptance

📧 Contact MDD via email or phone to book an appointment.

🧾 Required Forms Summary

FormPurposeSubmitted By
MD100LRP RegistrationLRP
MD101Manufacturer RegistrationManufacturer or LRP
MD102Device Listing (Class C)LRP
MD151Adverse Event Report (Post-listing)LRP

📌 Quick Submission Checklist

ItemRequired
MD100 – LRP Registration✅
MD101 – Manufacturer Registration✅
MD102 – Device Listing Form✅
Technical dossier (paper)✅
Technical dossier (USB/CD)✅
Proof of reference market approval✅
ISO 13485 certificate✅
Labeling & IFU✅
Essential Principles Checklist✅
Signed Declaration of Conformity✅

📥 Need Templates or Samples?

Let me know if you'd like:

  • Sample completed Form MD102

  • A checklist PDF for submission

  • Sample LRP authorization letter

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Contact Us：

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


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