Registering a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong involves a structured, multi-step process. Although MDACS is currently voluntary (except for some public hospital procurements), it is widely used and accepted by the Department of Health and required by many public healthcare buyers.

Here is a complete breakdown of the process and steps for applying for Class C MDACS registration:

🔹 Overview of the MDACS Registration Process for Class C Devices

There are 7 key steps in the application process:

🔎 Step-by-Step Guide

✅ Step 1: Determine Device Classification (Class C)

Use MDACS Guidance Note GN-01 to classify your device.

Class C typically includes:

• Devices with moderate to high risk

• Invasive or surgically invasive short-term devices

• Active devices controlling or monitoring other devices (e.g., infusion pumps, patient monitors)

📄 You should document your classification rationale.

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

If the manufacturer is not located in Hong Kong, an LRP must be appointed.

Actions:

• Submit Form MD100: Local Responsible Person registration

• Submit a letter of authorization from the manufacturer

• Provide business registration certificate of the LRP in Hong Kong

✅ The LRP is legally responsible for registration, updates, and post-market surveillance.

✅ Step 3: Ensure Reference Market Approval

To be eligible for MDACS listing, your device must already be approved in at least one reference market:

📎 Also provide: Free Sale Certificate (if available), Declaration of Conformity, and labeling from the reference market.

✅ Step 4: Register the Manufacturer with MDD

If not already registered, the manufacturer must be listed.

Submit:

• Form MD101: Manufacturer registration

• Manufacturer’s ISO 13485 certificate

• Device production site information

• Declaration of Conformity

✅ Step 5: Compile the Technical Dossier

Follow MDACS GN-02 and GN-03 for dossier structure.

Dossier contents:

• Device description

• Intended use

• Risk classification rationale

• Essential Principles checklist (GN-03)

• Clinical evaluation or summary

• Performance testing reports (e.g., IEC 60601, ISO 10993)

• Labeling and Instructions for Use (English or Chinese)

• Software validation (if applicable)

• Reference market approval documents

📁 Format:

• 1 printed copy

• 1 digital version (USB or CD-ROM)

✅ Step 6: Submit Application – Form MD102

This is the official application form for listing a Class C device.

Submit:

• Form MD102

• Technical dossier (paper + electronic)

• All supporting documents (CE/FDA approval, labels, etc.)

• Application cover letter

📬 Submission address:

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

✅ No application fee is currently required under MDACS.

✅ Step 7: Application Review and Listing Outcome

The Medical Device Division will:

• Review the dossier for completeness and accuracy

• May request clarifications or additional documents

• Evaluate the conformity with Essential Principles

• Verify LRP and manufacturer information

📅 Estimated timeline: 3–6 months (can vary depending on complexity and quality of documentation)

✅ If approved:

• The device is listed on the MDACS website

• The LRP will receive an official confirmation

• The device receives a Listing Number (HKMD No.)

📌 Summary Checklist

🧾 Optional but Recommended

Would you like:

• A pre-filled sample of Form MD102?

• A technical dossier folder structure?

• A submission checklist template?

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