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How to apply for Class B medical device MDACS registration in Hong Kong? Where to handle the application?
Release time：2025-05-26 16:01:54 The author: source:
To apply for Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a structured submission process managed by the Medical Device Division (MDD) of the Department of Health. Below is a complete guide:

To apply for Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a structured submission process managed by the Medical Device Division (MDD) of the Department of Health. Below is a complete guide:

📝 How to Apply for Class B MDACS Registration

✅ Step-by-Step Application Process

StepActionDetails
1. Appoint Local Responsible Person (LRP)The manufacturer must appoint a Hong Kong-based entity or individual to act as the LRP.The LRP handles registration, communication with the MDD, and post-market duties.
2. Register the LRP (if not yet registered)Submit Form MD-TR to register the LRP.No fee required.
3. Classify the DeviceUse MDACS classification rules to confirm the device is Class B.Based on GHTF principles.
4. Prepare DocumentationCompile all required documents (e.g., Form MD1, CE/FDA approval, ISO 13485, IFU).Documents must be in English or Chinese.
5. Fill Out Form MD1This is the core application form for device listing.Signed by the LRP.
6. Submit Application PackageSubmit hard copies of Form MD1, supporting documents, and HK$500 fee to the MDD.No online or email submission is accepted.
7. Wait for MDD ReviewThe MDD may raise questions or request clarifications.Review time is usually 4–8 weeks.
8. Receive Listing ConfirmationUpon approval, the device is listed under the MDACS.No formal certificate is issued, but the device is shown in the public database.

📍 Where to Submit the Application

🔹 Submission Address:

Medical Device Division (MDD)
Department of Health
14th Floor, Guardian House
32 Oi Kwan Road
Wan Chai, Hong Kong

🔹 Contact Information:

📨 Note: You must submit the application in person or by courier/mail—electronic submission is not accepted.

📦 What to Include in the Application Package

  1. Form MD1 – signed by the LRP

  2. Application Fee – HK$500 per device (by cheque to “The Government of the HKSAR”)

  3. Required documents:

    • Regulatory approval (e.g., CE, FDA, TGA)

    • ISO 13485 certificate

    • Labeling, packaging, and IFU

    • Declaration of Conformity

    • LRP appointment letter

    • Manufacturer info & product details

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Contact Us：

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


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