To register and apply for a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a detailed process administered by the Medical Device Division (MDD) of the Department of Health. Though the system is currently voluntary, it is essential for sales to public hospitals and is often required in local tenders.

✅ Overview: What Does Class C MDACS Registration Involve?

📝 Step-by-Step Guide: How to Apply for Class C MDACS Registration

🔹 Step 1: Confirm Classification of the Device

• Use MDACS Guidance GN-01 to determine if the product is Class C

• Typical Class C examples include:

  • Invasive surgical devices (short to long-term)

  • Diagnostic imaging systems

  • Infusion systems

  • Active monitoring devices

📌 Document your classification rationale as part of your technical file.

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

• The LRP must be a Hong Kong-registered company or entity

• If the manufacturer is not located in Hong Kong, the LRP acts as the legal contact point for the device

📄 Required Documents:

• Form MD100 (LRP Registration)

• LRP’s Business Registration Certificate

• Authorization Letter from the manufacturer

✅ The LRP is responsible for:

• Submitting the application

• Handling post-market surveillance

• Reporting incidents and maintaining compliance

🔹 Step 3: Obtain Reference Market Approval

The product must have valid regulatory approval in at least one recognized reference market, such as:

📎 Submit:

• CE/FDA/ARTG certificates

• Free Sale Certificate (if available)

• Declaration of Conformity

🔹 Step 4: Register the Manufacturer

If not already registered under MDACS:

📄 Submit Form MD101 with:

• Manufacturer’s ISO 13485 certificate

• Manufacturer details and location

• Device production site info

• Declaration of Conformity

🔹 Step 5: Prepare the Technical Documentation

Your technical file must comply with GN-02 (submission format) and GN-03 (Essential Principles).

Must include:

• Device description and intended use

• Classification rationale

• Labeling (IFU, packaging) in English or Chinese

• Clinical evaluation data or equivalence justification

• Safety & performance testing (ISO 10993, IEC 60601, EMC, etc.)

• Software validation (if applicable – IEC 62304)

• Essential Principles checklist (GN-03)

📁 Format:

• One printed copy

• One digital copy (CD-ROM or USB)

🔹 Step 6: Submit the Application

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

📬 Deliver to:

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

💰 Fees: Currently, no application fee is required.

🔹 Step 7: MDD Review and Clarification

Once submitted:

• Administrative screening: Check for completeness (2–4 weeks)

• Technical review: Evaluate safety, performance, and compliance (2–4 months)

• MDD may issue a Request for Further Information (RFI) if needed

📌 Tip: Respond to RFIs within 2–4 weeks to avoid delay.

🔹 Step 8: Listing Decision

If approved:

• The device receives a Hong Kong Medical Device Number (HKMD No.)

• It is published on the MDACS Listed Devices Database

• You receive an official listing confirmation letter

🕒 Total Time Estimate: 3–9 months (varies based on submission quality and response time)

📋 Summary Checklist for Application

🔄 After Listing: Maintenance Obligations

Contact Us：

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