To register and apply for a Class D medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a clear and structured procedure governed by the Medical Device Division (MDD) of the Department of Health (DoH). Class D is the highest risk category, and therefore the registration demands detailed documentation and strict regulatory compliance.

✅ Overview: How to Register & Apply for Class D MDACS in Hong Kong

The full application process includes:

1. Confirm Device Classification (Class D)

2. Appoint a Local Responsible Person (LRP)

3. Prepare Technical Documentation

4. Register with MDIS & Submit Application

5. MDD Review and Clarification

6. Approval and Listing

7. Post-Market Compliance

🔷 Step-by-Step Guide

🔹 Step 1: Confirm Device Classification

Refer to:

• GN-01 – for general medical devices

• GN-02 – for in vitro diagnostic (IVD) devices

💡 Class D includes:

• Life-sustaining/life-supporting devices

• Implantables (e.g. pacemakers, orthopedic implants)

• High-risk IVDs (e.g. HIV, HBV detection)

👉 Tip: Keep a written classification justification for submission.

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

You must appoint an LRP who is:

• A Hong Kong-registered entity

• Authorized by the manufacturer (via Manufacturer Authorization Letter)

The LRP’s responsibilities:

• Submit and manage the MDACS application

• Maintain communication with MDD

• Handle post-market surveillance, adverse events, and FSCA

📑 Required for LRP registration:

• Business registration certificate (HK)

• Manufacturer Authorization Letter (signed)

• LRP application form (from MDACS)

🔹 Step 3: Prepare Technical Documentation

For Class D devices, a full technical dossier is required.

Key documents include:

💡 Tip: Organize files clearly (PDF format), label by section for MDIS upload.

🔹 Step 4: Submit Application via MDIS

Use the Medical Device Information System (MDIS):
👉 https://mdis.mdco.gov.hk

Steps:

1. LRP registers/logs in to MDIS

2. Select "Apply for Listing of Medical Device"

3. Fill in device information (model, risk class, intended use)

4. Upload all required documents (PDF)

5. Submit electronically

📌 There is currently no application fee under MDACS.

🔹 Step 5: MDD Review and Clarification

The MDD will:

• Perform an administrative check (2–4 weeks)

• Conduct a technical review (3–6 months)

• Issue requests for clarification if documents are missing or unclear

⏱ Response time for clarification is usually 10–30 calendar days.

🔹 Step 6: Approval and Listing

If approved:

• You receive a Letter of Acceptance

• Your device is listed under MDACS

• A Listing Number (e.g., MDXXXXXX) is issued

• Listing is published on the MDACS website

📌 Listing is valid for 5 years and can be renewed.

🔹 Step 7: Post-Market Compliance

Once listed, you must:

📑 Summary Flowchart

css复制编辑[Classify Device] → [Appoint LRP] → [Prepare Docs] → [Submit via MDIS]
↓↓↓[Admin Review] → [Tech Review] → [Clarifications] → [Approval & Listing]
↓[Post-Market Compliance & Renewal]

⏱ Estimated Timeline

🧰 Optional: Tools to Help You Apply

I can provide:

• ✅ Editable application checklist

• ✅ Essential Principles template (GN-01 / GN-02)

• ✅ Sample Declaration of Conformity

• ✅ Sample Risk File structure (ISO 14971)

• ✅ Response letter template for clarification (RFC)

Let me know your device type (e.g. general or IVD) and I’ll tailor these for your product.

Contact Us：

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