What Does Class C Medical Device MDACS Registration in Hong Kong Mean?

Under Hong Kong’s Medical Device Administrative Control System (MDACS), the registration (listing) of a Class C medical device refers to the voluntary inclusion of the device into a recognized list maintained by the Medical Device Division (MDD) of the Department of Health.

Although not legally mandatory, MDACS listing is required for government tenders (e.g., the Hospital Authority), and is widely recognized by private hospitals and clinics in Hong Kong as a quality assurance mechanism.

🔍 What Is a Class C Medical Device?

According to MDACS classification guidelines (GN-01), Class C medical devices are:

• Medium-High Risk devices

• Examples include:

  • Anesthesia machines

  • Dialysis equipment

  • Diagnostic X-ray systems

  • Some types of surgical lasers

Class C sits one level below the highest-risk Class D, and above Classes A and B.

📝 How to Apply for Class C Medical Device MDACS Registration?

Here’s a step-by-step guide for applying under MDACS:

📌 Step 1: Determine Device Classification

Refer to GN-01 (Guidance Notes for Classification System for General Medical Devices) to confirm your device is indeed Class C.

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

If the manufacturer is not based in Hong Kong, an LRP (Local Responsible Person) must be appointed.

The LRP is responsible for:

• Submitting the application

• Post-market surveillance

• Communication with the Department of Health

✅ LRP must be:

• A company or entity registered in Hong Kong

• Familiar with medical device regulations

• Registered as an LRP with MDD (using Form MD100)

📌 Step 3: Prepare the Technical Documentation

Compile a technical dossier that proves your device's safety, effectiveness, and quality. This should comply with GN-02 and GN-03.

📄 Required documents typically include:

• Declaration of Conformity (DoC)

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

• Regulatory approval in at least one reference market (EU CE Mark, US FDA, TGA, etc.)

• Device description and specifications

• Risk analysis (ISO 14971 compliance)

• Clinical data (if required)

• IFU (Instructions for Use), labels, and packaging artwork

• Essential Principles checklist (per GN-03)

📌 All documents must be in English or Chinese.

📌 Step 4: Submit Form MD102 – Application for Listing

The LRP submits Form MD102 to the MDD along with all supporting documents.

📌 Submit To:

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

📎 Note: You may also include a soft copy of the application on CD/DVD or USB drive.

📌 Step 5: Application Review by MDD

The Department of Health will review:

• Whether the device meets safety and performance requirements

• Completeness and authenticity of submitted documentation

• Approval status in reference markets

⏳ Review Time: Typically 4–6 months, depending on complexity and application quality.

📌 Step 6: Device Listing Approval

If the review is successful, you will receive:

• An official listing letter

• A device listing number

• Your product will appear in the MDACS Device List

🔁 Validity: No expiration, but you must:

• Notify the MDD of any changes

• Fulfill ongoing post-market duties (e.g., adverse event reporting using Form MD151)

📌 Summary of Application Forms

💰 Cost

• No official government fee for MDACS listing

• However, expect costs for:

  • Document preparation

  • Notarization or translation (if required)

  • LRP service fees

✅ Quick Summary Checklist

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