Registering a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong involves clearly defined procedures, required documents, and important precautions. Although MDACS is voluntary, it is often essential for supplying devices to public hospitals, participating in government tenders, and gaining acceptance in private clinics and hospitals.

🔹 1. Procedures for Class C MDACS Registration

✅ Step 1: Confirm Classification

Use Guidance Note GN-01 to verify that the device is Class C (medium-high risk). Examples include:

• Infusion pumps

• Diagnostic imaging systems

• Certain types of surgical lasers

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

If the manufacturer is not based in Hong Kong, they must appoint an LRP:

• A legally registered entity in Hong Kong

• Acts on behalf of the manufacturer

• Handles regulatory submissions, adverse event reporting, and communications with MDD

📄 Form Required:

• MD100 – Application for LRP Registration

• Manufacturer Authorization Letter – authorizing the LRP

✅ Step 3: Register the Manufacturer

Before device listing, the manufacturer must be registered with the MDD.

📄 Form Required:

• MD101 – Application for Manufacturer Listing
  🧾 Attach:

• ISO 13485 certificate

• Declaration of Conformity

• Contact details of manufacturing site

✅ Step 4: Prepare the Technical Documentation

Compile a complete technical dossier demonstrating safety, quality, and performance.

📂 Documents Required:

• Device description and intended use

• Proof of reference market approval (e.g., CE, FDA, TGA, etc.)

• ISO 13485 certification

• Risk analysis per ISO 14971

• Clinical evidence or justification for equivalence

• Essential Principles checklist (per GN-03)

• Instructions for Use (IFU) and labels (in English/Chinese)

• Declaration of Conformity

• Design drawings and product photos

✅ Step 5: Submit Application for Device Listing

📄 Form Required:

• MD102 – Application for Listing of a Medical Device

📦 Submit the following:

• Printed application forms (MD100, MD101, MD102)

• Hard copy of technical dossier

• Electronic copy on USB drive or CD-ROM

📍 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: MDD Review and Approval

The MDD will:

• Check completeness and compliance

• Review technical documents

• Issue a Listing Certificate with a Device Listing Number upon approval

⏱️ Review Time: Approximately 4–6 months

✅ Step 7: Post-Listing Obligations

Once listed, the LRP must:

• Report adverse events (Form MD151)

• Notify the MDD of any device changes (labeling, manufacturer, specifications)

• Maintain records of distribution and complaints

📑 2. Required Materials Checklist

⚠️ 3. Precautions to Take During the Application

🔸 Ensure Reference Market Approval

At least one regulatory approval from:

• EU (CE Mark), USA (FDA), Canada (Health Canada), Australia (TGA), or Japan (PMDA)

📌 Tip: Devices approved in multiple reference markets get faster acceptance.

🔸 Maintain Labeling Accuracy

• Labels and IFU must be in English or Chinese

• They must match the reference market and Hong Kong requirements

🔸 Keep Dossier Well-Organized

• Include a document checklist

• Use section dividers and label everything clearly

• Ensure file names match the content descriptions on USB/CD

🔸 Respond Promptly to Queries

If the MDD requests clarification or additional data:

• Respond within the requested time

• Incomplete or delayed responses may result in rejection or longer review times

🔸 Choose a Qualified LRP

• The LRP must be familiar with Hong Kong’s regulatory framework

• An inexperienced LRP may cause submission delays or communication failures

📌 Summary Table

Would you like a downloadable checklist, editable versions of MD100/101/102, or a template for the Essential Principles Checklist? I can provide those to streamline your submission.

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