🇭🇰 Class A Medical Device Registration under Hong Kong MDACS – Overview and Application Process

🔹 What Is a Class A Medical Device?

Under the Medical Device Administrative Control System (MDACS) in Hong Kong, medical devices are classified into Classes A, B, C, and D according to risk level, with Class A representing the lowest risk.

🔸 Class A Devices – Examples:

• Manual wheelchairs

• Thermometers (non-electronic)

• Bandages and gauze

• Tongue depressors

• Surgical drapes (non-sterile)

• Examination gloves (non-sterile, non-measuring)

Devices must not be invasive, active, sterile, or measuring to qualify for Class A.

🔹 What Is MDACS?

The Medical Device Administrative Control System (MDACS) is a voluntary registration system managed by the Medical Device Division (MDD) of the Hong Kong Department of Health. It is designed to align with the International Medical Device Regulators Forum (IMDRF) framework.

🔹 Who Can Apply?

• Local Responsible Person (LRP): A person or company based in Hong Kong, appointed by the manufacturer to handle registration and regulatory compliance.

  • The LRP is mandatory for overseas manufacturers.

  • The LRP must be listed under MDACS before applying for device listing.

🔹 How to Apply for Class A Medical Device Registration

✅ Step 1: Confirm Device Classification

Refer to Guidance Note GN-01 to confirm the device is Class A based on:

• Intended use

• Invasiveness

• Whether it's sterile or measuring

✅ Step 2: Appoint an LRP (if required)

• The LRP handles submission and communication with the MDD.

• Must be based in Hong Kong and registered under MDACS.

✅ Step 3: Prepare Application Documents

Minimal requirements for Class A devices:

1. Completed Application Form [MD-TRF]

2. Device Description and intended use

3. Labeling and Instructions for Use (IFU)

4. Manufacturer’s Information

5. Conformity Assessment Certificate (if available)

   • e.g., CE Declaration of Conformity, FDA 510(k), ISO 13485

6. Justification for Class A classification

Reference documents:

• GN-01: Device Classification

• GN-02: Device Listing Requirements

✅ Step 4: Submit Application to MDD

• The application is submitted by the LRP via mail or in-person (electronic submissions may be supported in the future).

• No application fee is currently required.

✅ Step 5: Review and Listing

• MDD reviews the application and, if accepted, lists the device on the MDACS website.

• You will receive a Device Listing Number (no physical certificate).

🔹 Benefits of MDACS Listing

• Accepted in public hospital procurement

• Enhances market credibility

• Recommended for private hospital use

• Helps prepare for future mandatory regulations

📌 Summary Table

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