To handle Class C medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a structured process established by the Medical Device Division (MDD) of the Department of Health. Although MDACS is currently voluntary, it is required for participation in public hospital procurement and widely accepted in Hong Kong’s healthcare market.

Below is a step-by-step guide covering how to successfully prepare, apply, and manage Class C medical device registration in Hong Kong.

🔷 What Is a Class C Medical Device?

Under MDACS (aligned with the GHTF/IMDRF framework), Class C devices are medium to high-risk and often include:

• Infusion pumps

• Patient monitors

• Diagnostic imaging systems (e.g., ultrasound)

• Invasive surgical devices with short- to long-term use

Use Guidance GN-01 to confirm classification.

✅ Step-by-Step Guide: How to Handle MDACS Registration for Class C Devices

🔹 Step 1: Determine Device Classification

• Refer to GN-01 to confirm the device falls under Class C

• Document the rationale for classification

🔹 Step 2: Appoint a Local Responsible Person (LRP)

A Hong Kong-based Local Responsible Person (LRP) is mandatory if the manufacturer is located outside of Hong Kong.

The LRP will:

• Submit and maintain the registration

• Be the legal representative for regulatory matters

• Handle post-market surveillance and reporting

📄 Submit Form MD100 and a Letter of Authorization from the manufacturer.

🔹 Step 3: Ensure Reference Market Approval

The device must be approved in at least one of the following reference markets:

• European Union (CE marking under MDR or MDD)

• United States (FDA 510(k) or PMA)

• Australia (ARTG listing)

• Canada (MDL certificate)

• Japan (Shonin/PMDA approval)

📎 Prepare:

• Valid certificates

• Free Sale Certificate (if available)

• Declaration of Conformity

🔹 Step 4: Register the Manufacturer

If the manufacturer has not already been registered in Hong Kong, submit:

📄 Form MD101 with:

• Manufacturer details

• Valid ISO 13485 certificate

• Device manufacturing site info

• Manufacturer's Declaration of Conformity

🔹 Step 5: Compile the Technical Documentation

The dossier should be prepared following GN-02 and GN-03, including:

🖨️ Submit 1 printed copy and 1 USB/CD with identical content.

🔹 Step 6: Submit the Application (Form MD102)

• Fill and sign Form MD102 (device listing)

• Include all required documents and a submission letter

📬 Submit to:

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

📌 Note: There is currently no application fee for MDACS registration.

🔹 Step 7: Await Review and Respond to Queries

MDD will:

• Acknowledge your submission

• Conduct administrative and technical review

• Send Request for Further Information (RFI) if clarification is needed

⏱ Typical duration: 3–9 months
Respond to RFIs promptly to avoid delays.

🔹 Step 8: Device Listing and Maintenance

If approved:

• Your device will be listed on the MDACS website

• You’ll receive a Listing Confirmation Letter and HKMD No.

• The LRP becomes responsible for ongoing post-market obligations

🔄 Post-Registration Responsibilities

After approval, you must:

🧩 Key Documents and Forms

📝 Summary Checklist: Class C MDACS Registration

Contact Us：

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