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What materials are needed for Class A medical device registration under Hong Kong MDACS? How to prepare the application documents?
Release time：2025-05-14 14:07:43 The author: source:
To register a Class A medical device under Hong Kong’s MDACS (Medical Device Administrative Control System), you need to prepare and submit a complete set of documents to the Medical Device Division (MDD). Below is a full breakdown of the required materials and how to prepare each application document.

To register a Class A medical device under Hong Kong’s MDACS (Medical Device Administrative Control System), you need to prepare and submit a complete set of documents to the Medical Device Division (MDD). Below is a full breakdown of the required materials and how to prepare each application document.

✅ 1. Required Materials for Class A Medical Device Registration

DocumentDescriptionPreparation Tips
1. MD-TRF FormApplication form for listing a Class A medical deviceDownload the latest version from the MDACS website. Fill in all sections clearly, including device name, model, intended use, manufacturer, and Local Responsible Person (LRP) details.
2. Device DescriptionPhysical and functional description of the deviceProvide technical specifications, materials, dimensions, and product images or diagrams. Describe how the device works and what it is used for.
3. Classification JustificationRationale for why the device qualifies as Class AUse the classification rules in Guidance Note GN-01. Explain that the device is low-risk (e.g., non-invasive, non-sterile, no measuring function).
4. Labeling and PackagingCopies of labels, packaging, and Instructions for Use (IFU)Submit color scans of outer and inner labels. Labels must include: product name, model, manufacturer info, LRP info (if applicable), intended use, warnings, and batch/lot numbers. IFU should be in English or Traditional Chinese.
5. Manufacturer InformationCompany name, address, and contact detailsProvide proof of identity and contact details of the manufacturer, ideally including business registration or ISO certificate.
6. Regulatory Approval Evidence (Optional)CE Declaration of Conformity, FDA 510(k), ISO 13485, etc.Not mandatory for Class A, but strengthens the application. Helps demonstrate product safety and compliance with international standards.

✅ 2. How to Prepare the Application Documents

🔹 A. MD-TRF Form (Medical Device Listing Form)

  • Use the MDACS-provided format (Class A version).

  • Include:

    • Product trade name and model

    • Intended use

    • Manufacturer’s full name and address

    • LRP name and contact details

    • Device classification explanation

📌 Tip: Ensure all names, models, and contact details match across all documents.

🔹 B. Device Description Document

Include:

  • Clear product images

  • Technical specifications

  • Description of how it works

  • Materials used (if applicable)

📌 Tip: Keep it concise, 1–2 pages is usually sufficient for simple Class A devices.

🔹 C. Classification Justification

Explain which MDACS rule(s) apply from GN-01, e.g.:

"According to MDACS GN-01, Rule 1, the device is non-invasive and not intended for modification of body anatomy. It does not transmit energy or substances. Therefore, the product is correctly classified as a Class A device."

🔹 D. Labeling and Instructions for Use

Include:

  • Photos or scans of outer and inner packaging

  • IFU in English or Traditional Chinese

  • Labels showing:

    • Product name

    • Model number

    • Manufacturer name and address

    • Warnings and symbols

    • LRP name and address (if applicable)

📌 Tip: Use ISO 15223-1 and IEC 60601-1-2 labeling standards if available.

🔹 E. Manufacturer and Quality Info

Optional documents may include:

  • ISO 13485 certificate (if available)

  • Declaration of Conformity to CE/US FDA/other markets

📌 Tip: These are not required for Class A, but including them improves transparency and acceptance.

📬 Submission Method

  • Submit in person or by post (no online portal).

  • Address:

    Medical Device Division,
    Room 3101, 31/F, Hopewell Centre,
    183 Queen’s Road East,
    Wan Chai, Hong Kong

📌 Final Checklist for Submission

✅ MD-TRF Form (Class A version)
✅ Product Description
✅ Classification Justification
✅ Labeling and IFU
✅ Manufacturer’s Details
🔲 Optional: CE/FDA/ISO certificates

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


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