Handling Class C medical device registration under the MDACS (Medical Device Administrative Control System) in Hong Kong involves a structured process established by the Medical Device Division (MDD) under the Department of Health (DoH). The MDACS is a voluntary listing system, but listing is often required for public hospital tenders and increases acceptance in private hospitals and clinics.

Here is a detailed guide to help you manage the registration of a Class C medical device under MDACS:

🔹 1. Understand Device Classification

According to the Guidance Notes GN-01, medical devices are classified into Classes A, B, C, and D based on risk.

• Class C: Medium-high risk devices (e.g., ventilators, infusion pumps, or certain diagnostic X-ray systems).
  You must confirm the classification before starting the registration.

➡️ Reference: GN-01 “Guidance Notes for Classification System for General Medical Devices”

🔹 2. Appoint a Local Responsible Person (LRP)

If you are not located in Hong Kong, you must appoint an LRP, who will:

• Act as your official representative

• Submit the application to MDACS

• Be responsible for post-market surveillance and adverse event reporting

✅ LRP Requirements:

• A legal entity in Hong Kong

• Knowledge of medical devices and regulations

• Must be registered with the MDD

🔹 3. Prepare Required Technical Documents

Your Class C device must have been approved in one or more reference markets (US, EU, Canada, Australia, Japan) and comply with Essential Principles of Safety and Performance (GN-03).

🗂️ Documents needed include:

• Proof of market authorization in reference countries (e.g., FDA 510(k), CE Certificate, TGA ARTG entry)

• ISO 13485 certificate of the manufacturer

• Declaration of Conformity

• Device description, intended use

• Risk analysis and clinical data

• Labels, IFU, packaging artwork

• QMS compliance documents

➡️ Reference: GN-02 “Technical Reference for Pre-Market Submission”

🔹 4. Submit the Listing Application for the Medical Device

You or your LRP must fill out and submit Form MD102 for listing your Class C device with the Medical Device Administrative Control System.

📝 Key information required in Form MD102:

• Device name and description

• Class and intended use

• Manufacturer details

• Conformity assessment certification

• Summary of clinical evidence

📌 Submission format: Physical submission at the Medical Device Division’s office (may also require an e-copy).

🔹 5. Wait for Listing Review and Approval

⏳ Review Time:

• Typically 4 to 6 months, depending on the completeness and complexity of the application.

📬 You will receive a listing certificate if approved. The device will be assigned a Device Listing Number and listed in the MDACS online database.

🔹 6. Post-Listing Obligations

Once listed, there are ongoing requirements:

• Adverse event reporting (Form MD151)

• Change notifications (e.g., labeling changes, design modifications)

• Recalls or safety alerts

• Renewal is not required, but you must inform MDD of major changes

🔹 7. Cost Considerations

💰 While MDACS does not charge a registration fee, you may incur costs for:

• Document preparation

• Translation (if applicable)

• LRP service fees

• Third-party certification (e.g., ISO 13485 audits)

🔹 8. Where to Submit

📍Medical Device Division – Department of Health
Room 3101, 31/F, Hopewell Centre,
183 Queen’s Road East, Wan Chai, Hong Kong
📞 Tel: +852 3107 8451
🌐 Website: https://www.mdd.gov.hk

✅ Summary Checklist

✳️ Tips for Success

• Use approved devices in reference markets for easier acceptance.

• Ensure document translations (e.g., IFU) are accurate and professionally done.

• Maintain close communication with your LRP—they are your gateway to MDACS.

• Prepare early; the process is voluntary, but critical for public hospital access.

Contact Us：

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