To register a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a set of structured procedures laid out by the Medical Device Division (MDD) under the Department of Health.

While MDACS registration is voluntary, it is often essential for:

• Supplying to public hospitals (Hospital Authority)

• Winning government tenders

• Gaining recognition in private hospitals and clinics

🧭 Step-by-Step Procedures for Class C Medical Device MDACS Registration in Hong Kong

🔹 Step 1: Confirm Classification as Class C

Determine your device’s classification using the GN-01 Guidance Notes:

• Class C devices are medium-high risk (e.g., anesthesia machines, dialysis systems, X-ray imaging systems).

• Classification is based on the intended use, mode of action, and degree of invasiveness.

📄 Reference: GN-01 - Classification Guidelines

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

If the manufacturer is not based in Hong Kong, an LRP must be designated.

🔑 The LRP is legally responsible for:

• Submitting the registration application

• Post-market surveillance

• Communication with the MDD

✅ Requirements for LRP:

• Registered business in Hong Kong

• Must register as an LRP using Form MD100

• Must have the manufacturer’s authorization letter

📎 Tip: A distributor, agent, or third-party consultant in Hong Kong can act as the LRP.

🔹 Step 3: Register the Manufacturer (Form MD101)

The manufacturer of the device must also be registered with the MDD.

📄 Submit Form MD101, including:

• Manufacturer name, address

• Quality Management System (e.g., ISO 13485)

• Declaration of conformity

🔹 Step 4: Prepare Technical Documentation

The application must include a complete technical dossier that demonstrates conformity with safety, quality, and performance standards, as required in GN-02 and GN-03.

📁 Key documents include:

1. Device description and intended use

2. Essential Principles Checklist (GN-03 compliance)

3. Conformity Assessment Documents (e.g., CE certificate, FDA 510(k), TGA ARTG entry)

4. QMS Certificate (e.g., ISO 13485)

5. Risk Analysis Report (ISO 14971-based)

6. Clinical Evaluation or Performance Data

7. Labels and Instructions for Use (IFU)

8. Declaration of Conformity

9. List of Reference Market Approvals (minimum one reference market: US, EU, Canada, Australia, or Japan)

📎 All documents must be in English or Chinese.

🔹 Step 5: Submit Application for Device Listing (Form MD102)

This is the core submission step.

📄 Complete and submit Form MD102 – Application for Listing of Medical Device.

📦 Submit with:

• A printed copy of the form

• One set of all technical documentation

• A digital copy (USB or CD) of the full dossier

📍 Submission Address:

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

🔹 Step 6: Application Review by MDD

The MDD will assess:

• Device classification

• Regulatory approval in reference markets

• Completeness and validity of technical documentation

🕒 Typical review time: 4–6 months
⏳ This may be longer if the documents are incomplete or if clarification is needed.

🔹 Step 7: Listing Decision and Approval

If approved, the MDD will:

• Issue an official listing letter

• Assign a Listing Number

• Add your device to the MDACS online listing database

🎯 Once listed, you are officially recognized by MDACS, increasing your chances of successful tender participation and import clearance.

🔹 Step 8: Fulfill Post-Listing Obligations

Once listed, you have ongoing responsibilities, including:

📌 Post-Market Surveillance:

• Monitor safety and performance

• Report adverse events using Form MD151

📌 Change Notifications:

• Notify MDD of any changes to the device, packaging, manufacturer, or labeling.

📌 Document Maintenance:

• Ensure all documents are updated

• Keep records of distribution and complaints

📋 Required Forms Summary

📌 Additional Information

• Fees: No government fee for MDACS listing, but LRP services and testing documentation may cost money.

• Renewal: No expiration date, but changes must be reported promptly.

• Language: Documentation must be in English or Chinese.

✅ Quick Process Flowchart

1. ✔ Confirm Class C classification

2. ✔ Appoint LRP and register with Form MD100

3. ✔ Register manufacturer with Form MD101

4. ✔ Compile technical dossier per GN-02

5. ✔ Submit Form MD102 + documents

6. ✔ Await MDD review (4–6 months)

7. ✔ Receive listing certificate

8. ✔ Perform post-market surveillance

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