Applying for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) involves a structured series of procedures governed by the Medical Device Division (MDD) of the Department of Health. Although MDACS is a voluntary system, it is essential for participating in public hospital procurement and widely recognized across the Hong Kong medical market.

Below is a detailed, step-by-step explanation of the procedures for Class C medical device MDACS registration:

🔷 Overview of the MDACS Class C Registration Procedures

The registration procedure for a Class C medical device under MDACS includes:

🔎 Step-by-Step Breakdown

✅ Step 1: Determine Device Classification

• Refer to MDACS Guidance Note GN-01

• Class C devices are medium to high-risk, including:

  • Invasive surgical tools

  • Infusion pumps

  • Diagnostic and monitoring systems

  • Life-supporting devices (short-term)

📄 Keep documentation of your classification rationale for submission.

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

If the manufacturer is not based in Hong Kong, a Hong Kong-registered company or person must be designated as the LRP.

📄 Required actions:

• Fill and submit Form MD100

• Provide a Letter of Authorization from the manufacturer

• Submit LRP’s business registration certificate

🛡 The LRP is legally responsible for device registration, updates, and post-market reporting.

✅ Step 3: Ensure Reference Market Approval

The device must already be approved in at least one reference market:

• EU (CE marking under MDR or MDD)

• US (FDA 510(k) or PMA)

• Australia (ARTG)

• Canada (MDL)

• Japan (PMDA or Shonin)

📎 Submit:

• Valid regulatory certificates

• Declaration of Conformity

• Free Sale Certificate (if available)

✅ Step 4: Register the Manufacturer

If the manufacturer has not yet registered in MDACS:

📄 Submit Form MD101 along with:

• Manufacturer’s ISO 13485 certificate

• Information on manufacturing sites

• Signed Declaration of Conformity

✅ Step 5: Prepare the Technical Dossier

Prepare your submission in line with GN-02 (Submission Format) and GN-03 (Essential Principles).

Include the following:

📦 Format:

• One printed copy

• One electronic copy (on USB drive or CD-ROM)

✅ Step 6: Submit the Listing Application

📄 Complete and submit Form MD102 (Device Listing Application) along with:

• Technical dossier (paper + digital)

• Cover letter summarizing contents

• Forms MD100, MD101 (if not submitted before)

📬 Submit to:

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

📝 There is no application fee as of now.

✅ Step 7: Await Review and Respond to Requests

MDD will:

• Conduct an administrative screening (2–4 weeks)

• Perform a technical evaluation (2–4 months)

If clarification or additional information is needed, MDD will issue a Request for Further Information (RFI). You should respond within 2–4 weeks, or request an extension.

📌 Tip: Prompt and complete responses reduce delays.

✅ Step 8: Receive Listing Confirmation

If approved:

• MDD will issue a Listing Confirmation Letter

• Your product will appear on the MDACS Listed Medical Device Database

• You’ll receive a Hong Kong Medical Device Number (HKMD No.)

There is no expiry date for the listing, but regular updates and post-market vigilance are required.

📦 Document Summary

🔄 Ongoing Obligations After Registration

Once the device is listed:

• 🔁 Update MDD of any changes to labeling, certificate, manufacturer, or LRP

• 🛡️ Report serious adverse events using Form MD151

• 📦 Notify MDD of recalls or field safety corrective actions (FSCAs)

• 🧾 Maintain documentation for at least 5 years

📝 Summary Flowchart

1. ✅ Confirm classification (Class C)

2. ✅ Appoint & register LRP (MD100)

3. ✅ Register manufacturer (MD101)

4. ✅ Gather reference market approval

5. ✅ Prepare technical dossier (GN-02 & GN-03)

6. ✅ Submit Form MD102 + documents

7. ✅ Respond to RFIs from MDD

8. ✅ Receive listing and maintain compliance

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